Proactiveinvestors United Kingdom ImmuPharma PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom ImmuPharma PLC RSS feed en Wed, 12 Dec 2018 21:09:45 +0000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - ImmuPharma says managed access programme for Lupozor progressing as planned ]]> https://www.proactiveinvestors.co.uk/companies/news/210762/immupharma-says-managed-access-programme-for-lupozor-progressing-as-planned-210762.html ImmuPharma PLC (LON:IMM) shares rose on Friday as the biopharma firm revealed that the managed access programme (MAP) for Lupozor, its late-stage treatment for auto-immune disease Lupus is progressing as planned.

In an update on corporate activities, the AIM-listed firm said that following analysis of the regulatory processes in EU countries, it is planned to begin patient recruitment for the programme in France and UK and then roll out to other EU countries.

WATCH: ImmuPharma firmly committed to Lupuzor ahead of managed access programme

Tim McCarthy, ImmuPharma’s chairman, said: "We are delighted to be progressing the necessary activities for the Managed Access Programme, allowing Lupus patients early access to Lupuzor.

 “In conjunction, in the medium term we remain focused on achieving the full regulatory approval of Lupuzor, which we are confident has the potential to be a ground-breaking drug for Lupus patients.”

The company also said that, further to the ‘Heads of Terms’ agreement announced on 7 September 2018 regarding a clinical development collaboration for its Nucant cancer programme with specialist oncology development company, Incanthera Limited, the two companies are making good progress in finalising the 'Definitive Licence Agreement' within the exclusivity period up to 31 December 2018.

Ureka evaluation process

ImmuPharma also stated in its announcement of 7 September that it would commence a process of considering all opportunities to divest its Ureka business, and said today that, following this period of review, the firm intends to engage the services of a leading specialist R&D and advisory firm in the sector, to support the evaluation of Ureka's technologies and drug candidates and the development activities for the progression of its assets and the business.

It added: “This process is ongoing and further updates will be announced as appropriate.”

McCarthy commented: "Our Nucant programme and Ureka subsidiary continue to progress with their separate strategies, both having the ultimate goal of achieving value for all stakeholders going forward.”

McCarthy also said that active discussions regarding the appointment of a new NOMAD are ongoing and added: “We look forward to updating the market and shareholders again in the near future."

In early morning trading, ImmuPharma shares were 6% higher at 13p.

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Fri, 07 Dec 2018 08:56:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/210762/immupharma-says-managed-access-programme-for-lupozor-progressing-as-planned-210762.html
<![CDATA[RNS press release - Update on Corporate Activities ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181207070005_13895038/ Fri, 07 Dec 2018 07:00:05 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181207070005_13895038/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181129164041_13885842/ Thu, 29 Nov 2018 16:40:41 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181129164041_13885842/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181129163514_13885833/ Thu, 29 Nov 2018 16:35:14 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181129163514_13885833/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181128164049_13884157/ Wed, 28 Nov 2018 16:40:49 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181128164049_13884157/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181128163513_13884144/ Wed, 28 Nov 2018 16:35:13 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181128163513_13884144/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181123164048_13879122/ Fri, 23 Nov 2018 16:40:48 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181123164048_13879122/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181123163539_13879110/ Fri, 23 Nov 2018 16:35:39 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181123163539_13879110/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181121164039_13876045/ Wed, 21 Nov 2018 16:40:39 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181121164039_13876045/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181121163537_13876067/ Wed, 21 Nov 2018 16:35:37 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181121163537_13876067/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181107163516_13859040/ Wed, 07 Nov 2018 16:35:16 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181107163516_13859040/ <![CDATA[RNS press release - Nominated Adviser Status ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181101133800_13851796/ Thu, 01 Nov 2018 13:38:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20181101133800_13851796/ <![CDATA[News - ImmuPharma boss excited by “blockbuster potential” of Lupuzor ]]> https://www.proactiveinvestors.co.uk/companies/news/205719/immupharma-boss-excited-by-blockbuster-potential-of-lupuzor-205719.html The chief executive of ImmuPharma PLC (LON:IMM) has told investors he is excited by the “blockbuster potential” of the company’s flagship lupus treatment, Lupuzor.

Earlier this month, ImmuPharma signed an agreement which will see it progress with a managed access programme, giving up to 500 lupus sufferers access to Lupuzor for a minimum of two years.

WATCH: ImmuPharma committed to Lupuzor ahead of managed access to programme

In addition to helping patients, the AIM-quoted drug developer expects to collect more valuable data on Lupuzor, which will be useful if and when it decides to press ahead with regulatory filings.

In April, the drug missed its primary endpoint in a late-stage study, but the outcome was more nuanced than the top line results suggested and actually showed that Lupuzor worked well in certain patients, chiefly those who were antibody-positive.

After the end of the phase III trial, 62 patients took part in a ‘follow-up’ study – called an open-label extension study. Results from this are expected in the second quarter of 2019.

Full regulatory approval

“It has been a busy period for the board following the announcement of the phase III trial results for Lupuzor in April 2018,” said chief executive Tim McCarthy.

“We were obviously disappointed with the outcome of the phase III trial results but are excited to be progressing the managed access programme with a new strategic partner, which allows lupus patients early access to Lupuzor.

“In the medium term, we remain focused on achieving the full regulatory approval of Lupuzor which we believe has the potential to be a ground-breaking drug for lupus patients with blockbuster potential in commercial terms.”

Nucant cancer programme making progress

Lupuzor isn’t ImmuPharma’s only drug going through the clinic. Its Nucant cancer treatment has yielded “promising results” in two phase I safety and dose-finding studies.

The company has signed heads of terms on a clinical development collaboration with oncology specialist Incanthera, in which ImmuPharma has taken a £2mln stake.

A licence agreement between the two is expected to be signed by the end of the year, a deal which is likely to see Incanthera pay an upfront licence fee of £1mln in shares and cover all of the development costs for the Nucant programme.

All future commercialisation revenues will be shared equally, ImmuPharma said.

Ureka to be divested

As for the firm’s Ureka subsidiary, which is looking to develop treatments for type II diabetes and NASH, the decision was recently made to sell it.

Despite having “exciting and innovative technologies”, the board does not see as part of the long-term strategy.

As a result, the plan is to divest the Bordeaux-based subsidiary whilst still retaining an interest should any of its drugs achieve some commercial success further down the line.

“Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years.  We are equally excited by the potential of both,” said McCarthy.

“We believe the strategy we announced earlier this month, together with a robust financial position, will create enhanced value for shareholders going forward.”

Well-funded

Speaking of that “robust financial position”, thanks to a £10mln fundraise in January, ImmuPharma had £9.0mln of cash in the bank (H1 17: £2.7mln) at the end of June. Net assets grew to £9.9mln (H1 17: £3.6mln).

The company posted a loss for the six months to June 30 of £4.1mln, up from £3.0mln a year ago, reflecting a slight rise in R&D costs.

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Wed, 26 Sep 2018 07:40:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/205719/immupharma-boss-excited-by-blockbuster-potential-of-lupuzor-205719.html
<![CDATA[RNS press release - Interim Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180926070002_13804481/ Wed, 26 Sep 2018 07:00:02 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180926070002_13804481/ <![CDATA[News - Managed access programmes offer an alternative way forward for drug companies ]]> https://www.proactiveinvestors.co.uk/companies/news/205331/managed-access-programmes-offer-an-alternative-way-forward-for-drug-companies-205331.html Managed access programmes (MAPs) have been around for some time, offering poorly people access to drugs that aren’t currently fully licensed or are unavailable in a particular country.

Patients often receive the new, unapproved medication on compassionate grounds, while the MAPs themselves tend to be overseen by specialist drugs firms.

Here in the UK, Clinigen has run over 250 programmes providing ‘off-label’ treatments to those in acute medical need.

Eighteen of the top 20 big pharmaceutical companies now provide early access to their drugs.

Source of rich data 

In fact, MAPs are becoming a rich data source with patient-reported outcome information bundled up with the stats gleaned from clinical trials, which is then submitted to the regulator.

“Merck ran a MAP programme for Keytruda that formed an invaluable part of the regulatory filing that they were able to get reimbursement on,” said Tim McCarthy, chairman of ImmuPharma (LON:IMM).

Keytruda is one of a new breed of immunotherapy drugs that could help revolutionise the treatment of the killer disease.

McCarthy’s reference to the Merck breakthrough was by way of example as of what can be achieved using MAPs as ImmuPharma prepares to go down the same route.

500 patients to be treated

It will offer 500 patients with the autoimmune disease lupus access to Lupuzor, which generated mixed data in phase III clinical trial.

“We can get valuable data on the drug,” McCarthy told Proactive’s, Andrew Scott.

“We call this real-world data. I should stress, this is not a clinical study. All patients will get the drug, there will be no comparator group, blinding or randomisation.”

The MAP will be around a tenth of the cost of the last ImmuPharma clinical with patients receiving the medication free of charge for two years.

“This approach is getting a lot of traction now in our industry,” said McCarthy.

FOR THE FULL PROACTIVE INTERVIEW CLICK THIS LINK 

Despite the phase III setback for Lupuzor, ImmuPharma still plans to make a regulatory filing.

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Thu, 20 Sep 2018 12:49:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/205331/managed-access-programmes-offer-an-alternative-way-forward-for-drug-companies-205331.html
<![CDATA[RNS press release - Appointment of Joint Brokers ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180919070005_13795823/ Wed, 19 Sep 2018 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180919070005_13795823/ <![CDATA[Media files - ImmuPharma firmly committed to Lupuzor ahead of managed access programme ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/10512/immupharma-firmly-committed-to-lupuzor-ahead-of-managed-access-programme-10512.html Tue, 18 Sep 2018 14:31:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/10512/immupharma-firmly-committed-to-lupuzor-ahead-of-managed-access-programme-10512.html <![CDATA[News - ImmuPharma’s flagship lupus drug to be made available to patients ahead of regulatory filing ]]> https://www.proactiveinvestors.co.uk/companies/news/204410/immupharmas-flagship-lupus-drug-to-be-made-available-to-patients-ahead-of-regulatory-filing-204410.html Some lupus patients will soon have access to a potentially “ground-breaking” new treatment after Immupharma PLC (LON:IMM) signed an agreement which will see it press ahead with a managed access programme (MAP).

The deal with a specialist provider will allow up to 500 sufferers ongoing access to Immupharma’s flagship drug, Lupuzor, for a minimum of two years.

In addition to helping patients, the AIM-quoted drug developer expects to collect more valuable data on Lupuzor, which will be useful if and when it decides to press ahead with regulatory filings.

WATCH: ImmuPharma firmly committed to Lupuzor ahead of managed access programme

Earlier this year, the drug missed its primary endpoint in a late-stage study, but the outcome was more nuanced than the top line results suggested and actually showed that Lupuzor worked well in certain patients, chiefly those who were antibody-positive.

After the end of the phase III trial, 62 patients took part in a ‘follow-up’ study – called an open-label extension study. Results from this are expected in the second quarter of 2019.

READ: ImmuPharma says pre-clinical study points to other indications for Lupuzor

“The board has been focused on delivering a business strategy which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, resources and know-how,” said chairman Tim McCarthy.

“We are excited as a team to be progressing the MAP programme which allows Lupus patients early access to Lupuzor.

“In the medium term, we remain focused on achieving the full regulatory approval of Lupuzor which we believe has the potential to be a ground-breaking drug for Lupus patients and in turn has blockbuster potential in commercial terms.”

Nucant cancer programme making progress

Lupuzor isn’t ImmuPharma’s only drug going through the clinic. Its Nucant cancer treatment has yielded “promising results” in two phase I safety and dose-finding studies.

The company has signed heads of terms on a clinical development collaboration with oncology specialist Incanthera, in which ImmuPharma has taken a £2mln stake.

A licence agreement between the two is expected to be signed by the end of the year, a deal which is likely to see Incanthera pay an upfront licence fee of £1mln in shares and cover all of the development costs for the Nucant programme.

All future commercialisation revenues will be shared equally, ImmuPharma said.

Ureka to be divested

As for the firm’s Ureka subsidiary, which is looking to develop treatments for type II diabetes and NASH, the decision has been made to sell it.

Despite having “exciting and innovative technologies”, the board does not see as part of the long-term strategy.

As a result, the plan is to divest the Bordeaux-based subsidiary whilst still retaining an interest should any of its drugs achieve some commercial success further down the line.

“Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years,” added McCarthy.

“We are equally excited by the potential of both. We believe the strategy we have announced today for both, will create enhanced value for shareholders going forward.”

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Fri, 07 Sep 2018 08:05:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/204410/immupharmas-flagship-lupus-drug-to-be-made-available-to-patients-ahead-of-regulatory-filing-204410.html
<![CDATA[RNS press release - Corporate Update ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180907070003_13782249/ Fri, 07 Sep 2018 07:00:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180907070003_13782249/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180710164026_13712790/ Tue, 10 Jul 2018 16:40:26 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180710164026_13712790/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180710163513_13712782/ Tue, 10 Jul 2018 16:35:13 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180710163513_13712782/ <![CDATA[RNS press release - Result of AGM ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180628121612_13697701/ Thu, 28 Jun 2018 12:16:12 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180628121612_13697701/ <![CDATA[News - ImmuPharma says pre-clinical study points to other indications for lead drug ]]> https://www.proactiveinvestors.co.uk/companies/news/198848/immupharma-says-pre-clinical-study-points-to-other-indications-for-lead-drug-198848.html Pre-clinical work by ImmuPharma PLC (LON:IMM) on P140, the peptide currently being developed as Lupuzor for the treatment of people with lupus, reveals it may have other potential indications.  

The company's co-founder, Professor Sylviane Muller, and her team believe the drug could be deployed to treat an autoimmune disease called chronic inflammatory demyelinating polyneuropathy, or CIDP.

This a condition where medication is currently lacking and which is characterised by fatigue, diminished or absent tendon reflexes and sensory deficits, usually starting in the hands and feet.

CLICK HERE: For the full announcement 

The results of the pre-clinical study have been published in the Journal of Autoimmunity.

"Over the last couple of years we have provided further evidence of the role the P140 peptide can take in the potential treatment of other autoimmune diseases in addition to Lupus," said Muller.

"We are delighted that these results demonstrate positive pre-clinical data in a murine model of CIDP, which has no available disease-specific treatment.  We look forward to providing a further update on the progress of our CIDP programme in due course."

 

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Thu, 14 Jun 2018 08:02:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/198848/immupharma-says-pre-clinical-study-points-to-other-indications-for-lead-drug-198848.html
<![CDATA[RNS press release - Results of CIDP Pre-Clinical Data ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180614070002_13678967/ Thu, 14 Jun 2018 07:00:02 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180614070002_13678967/ <![CDATA[RNS press release - Notice of AGM & Posting of Annual Report ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180606070013_13668380/ Wed, 06 Jun 2018 07:00:13 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180606070013_13668380/ <![CDATA[Media files - ImmuPharma chairman more optimistic on results for its Lupuzor drug ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9392/immupharma-chairman-more-optimistic-on-results-for-its-lupuzor-drug-9392.html Tue, 29 May 2018 15:56:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9392/immupharma-chairman-more-optimistic-on-results-for-its-lupuzor-drug-9392.html <![CDATA[News - ImmuPharma shares jump as chairman upbeat after phase III data review for flagship drug ]]> https://www.proactiveinvestors.co.uk/companies/news/197804/immupharma-shares-jump-as-chairman-upbeat-after-phase-iii-data-review-for-flagship-drug-197804.html ImmuPharma PLC (LON:IMM) shares jumped 6.5% higher on Tuesday after its chairman Tim McCarthy said he believes Lupuzor has the potential to offer lupus sufferers a much needed treatment after researchers took a deeper dive into the data generated by its phase III clinical trial of the company's flagship drug candidate.

Top line results from the study issued last month revealed the treatment missed its primary endpoint. It was efficacious, just not at a level that could be described as statistically significant.

However, the outcome was more nuanced than binary and the latest update perhaps underlines the chairman's optimism.

WATCH: ImmuPharma chairman more optimistic on results for its Lupuzor drug

The analysis revealed that, in the European group of lupus sufferers, Lupuzor had a statistically significant 71.1% response rate against a 48.8% rate in the control group, which received a dummy pill plus the standard of care.

Mixed results in the US

It should be noted, and this is important to the analysis, that in the European group 79 patients, or just under 61% of the group, were anti-body positive, which is a biomarker of the disease. 

In the US study group only 40% were was antibody positive where you'd expect 60-70% to be in this category. This may explain why the out-turn for the US could best be described as "mixed".

So, in the American cohort there were 72 patients, of which 28 were antibody positive, split equally between the active and placebo group. Five people were "responders" in the group receiving medication, while in the control group six responded.

The  anti-body positive result in particular "could allow identification of patients that are more likely to respond positively to treatment with Lupuzor", ImmuPharma said.

Disease modifying agent

Chief scientific officer Robert Zimmer added: "Current treatments (monoclonal antibodies, steroids etc) prescribed to Lupus patients are essentially symptomatic treatments acting irrespectively of the antibody status of the patients. 

"The potential efficacy of Lupuzor seems to be correlated with the presence of anti-dsDNA auto-antibodies, a biomarker for Lupus, and we hope to confirm that Lupuzor will come to be considered as a disease modifying agent.

"We believe this is in line with what healthcare practitioners are seeking: precision medicines to target therapies, using biomarkers that reference precisely those patients who could benefit from the treatment options available. This should reduce healthcare costs and improve patient outcomes."

Chairman McCarthy said the ImmuPharma treatment had a "compelling product profile", adding that he was "highly encouraged" by the anti-body positive result.

"We continue to believe Lupuzor has the potential to bring a much needed treatment to Lupus sufferers around the world. We look forward to providing our shareholders with further updates as we move forward with this programme," he went on.

By mid-morning trading, Immupharma shares were ahead 6.5% at 29.4p.

In a note to clients, analysts at ‘house’ broker Northland Capital said: “These findings are a positive for the Company and the potential commercial value of Lupuzor.

“The anti-dsDNA autoantibody is a significant biomarker within the lupus population and indicates a potential target population for Lupuzor.”

-- Adds analysts comment, updates share price --

 

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Tue, 29 May 2018 08:25:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/197804/immupharma-shares-jump-as-chairman-upbeat-after-phase-iii-data-review-for-flagship-drug-197804.html
<![CDATA[RNS press release - Update on Pivotal Phase III Trial of Lupuzor ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180529070015_13657074/ Tue, 29 May 2018 07:00:15 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180529070015_13657074/ <![CDATA[RNS press release - Final Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180529070014_13657077/ Tue, 29 May 2018 07:00:14 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180529070014_13657077/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180424115922_13616562/ Tue, 24 Apr 2018 11:59:22 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180424115922_13616562/ <![CDATA[News - ImmuPharma chairman and chief executive upbeat on Lupuzor; industry interest remains strong ]]> https://www.proactiveinvestors.co.uk/companies/news/195553/immupharma-chairman-and-chief-executive-upbeat-on-lupuzor-industry-interest-remains-strong-195553.html If it’s been a roller-coaster week for investors in the drug developer ImmuPharma PLC (LON:IMM), the stress doesn’t show in the demeanour of its two principals – chief executive Dimitri Dimitriou and Tim McCarthy, the chairman.

“Do we look down in the dumps?” asks McCarthy, before answering his own question. “Of course, we don’t.”

You’d suppose from the share price action there were more reasons to be fearful than cheerful following the publication of top-line data from the phase III clinical trial of Lupuzor, for the treatment of the autoimmune disease, lupus.

WATCH: ImmuPharma pair confident on dr​ug's future

On the face of it, the result wasn’t good as the drug missed its primary endpoint. It was efficacious, just not at a level that could be described as statistically significant; however, the devil was very much in the detail of the trial with a number of positives in the results that suggest the 67% fall in the share price this week was something of a knee-jerk reaction.

WATCH: Analyst gives his reaction to Lupuzor news

And these ‘positives’ also provide a very broad hint as to why Messrs Dimitriou and McCarthy were fairly relaxed when they joined Proactive 48 hours after the update.

First, there is more than a slim chance that the product will still make it to market and crucially, potential commercial partners are still interested in Lupuzor.

“We are at pains to point out this isn’t a failed drug,” said McCarthy.

“These are results for a drug that didn’t meet its primary end-point and that’s a difficult concept for a lot of people to understand.” 

As mentioned above, the data were nuanced rather than binary. As is normal for trial of this magnitude and importance, the ImmuPharma phase III study was a double-blind placebo-controlled study.

This is a simple concept: the doctors treating patients don’t know who is receiving the medication and who is being administered a pill or solution with no medical benefit at all – the placebo. Only at the end is it revealed who had what.

Nuanced results

The ImmuPharma trial was a little different. Patients in each group received the standard of care, which is normally some sort of steroid treatment, plus either the placebo or the Lupuzor.

So, while the response rate among the Lupuzor group was 52.5%, the placebo cohort showed an unusually strong response at 44.6%.

The latter number was higher than expected, based on what had been observed in phase II where the number was below 40%.

“If we had the same efficacy as we achieved in phase III and got the lower placebo response we saw in phase II then we would have seen statistical significance. That’s the subtle point,” said McCarthy.

And remember, patients in the placebo group probably weren’t responding to the placebo; rather, they were responding to the ongoing treatment they were receiving.

It is worth pointing out that 153 of the initial 202-strong patient group finished the 12-month course. In that smaller group, the response rate for Lupuzor was almost 70%, compared with 59% for the placebo.

Deep dive into the data 

In some cases, where patients possessed certain biomarkers, the response was statistically significant; indeed a small handful of patients went into full remission.

The plan now is to take a deep dive into the data. Then there are also conversations to be had with the regulators, who are likely to be a little more understanding than investors who bailed out.

“We need to have a discussion with the FDA [Food & Drug Administration] and EMA [European Medicines Agency] to see what they think because there have been trials where the end-point strictly speaking wasn’t met but the FDA understands what’s good for the patient and they understand context,” said CEO Dimitriou.

“You could have an optimistic scenario where you have conditional approval to make it [Lupuzor] freely available for the patient without having the formal approval. That’s the discussion to be had.”

More than 10 NDAs

At the same time, talks with potential industry partners are ongoing, with more than ten having signed non-disclosure agreements with ImmuPharma. The latest results don’t appear to have rattled potential collaborators.

“We sent them the top-line numbers to the people who we signed confidentiality agreements with. A lot came back the same day and some that didn’t have CDAs [confidentiality agreements] in place sent through CDAs the same day,” said Dimitriou.

McCarthy added: “The message to take away is we have done an awful lot of groundwork with these companies before we got these results. Within 48 hours we have shared the data and already had responses back.”

Agreeing a licensing deal traditionally takes around a year, though the competition can be a catalyst. And remember, Lupuzor has already been through the validation process having earlier in its history been licensed to Cephalon before the takeover of the US biotech saw the rights handed back.

But just why would big pharma be interested in Lupuzor?

Well, lupus sufferers, of whom there are around 5mln worldwide, are incredibly poorly served. The standard treatment is steroid-based, which has many side-effects, while the GlaxoSmithKline-made Benlysta, the first drug in the space for 50 years, also has significant drawbacks. This and the cost of Benlysta means that probably no more than around 13,000 patients have been treated.

A side-effect free alternative?

Even with that limited group, the GSK drug generated US$400mln of revenues. Imagine if you could get a side-effect-free alternative to market. One would assume the take-up rate would be much higher.

“Lupuzor is still a potential multi-billion dollar selling drug. The trial hasn’t done anything to alter that,” said chairman McCarthy.

“In fact, if anything it has proven what we have always been saying about its product profile. It does no harm and benefits patients.”

And all of this is said with a smile.

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Mon, 23 Apr 2018 11:18:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195553/immupharma-chairman-and-chief-executive-upbeat-on-lupuzor-industry-interest-remains-strong-195553.html
<![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180420082406_13612356/ Fri, 20 Apr 2018 08:24:06 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180420082406_13612356/ <![CDATA[Media files - Immupharma PLC still confident on Lupuzor's future ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9106/immupharma-plc-still-confident-on-lupuzor-s-future-9106.html Thu, 19 Apr 2018 12:34:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9106/immupharma-plc-still-confident-on-lupuzor-s-future-9106.html <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180419080524_13610648/ Thu, 19 Apr 2018 08:05:24 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180419080524_13610648/ <![CDATA[Media files - ImmuPharma drug could still have a role in treating lupus – City analyst ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9078/immupharma-drug-could-still-have-a-role-in-treating-lupus-city-analyst-9078.html Tue, 17 Apr 2018 16:15:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9078/immupharma-drug-could-still-have-a-role-in-treating-lupus-city-analyst-9078.html <![CDATA[News - ImmuPharma drug needs further analysis; it could still have a role in treating lupus – City analyst ]]> https://www.proactiveinvestors.co.uk/companies/news/195172/immupharma-drug-needs-further-analysis-it-could-still-have-a-role-in-treating-lupus-city-analyst-195172.html ImmuPharma PLC's (LON:IMM) drug Lupuzor needs further analysis and certainly isn’t a bust, according to Vadim Alexandre, analyst at Northland Capital.

With shares down sharply on Tuesday, the reaction to phase III trial results for the lupus drug has been “knee-jerk” and probably not fully reflective of the outlook for the treatment, he said in an interview with Proactive’s Andrew Scott.

The readout from the study showed Lupuzor didn’t have a statistically significant impact on patients compared with the placebo plus the standard of care.

WATCH: Immupharma PLC still confident on Lupuzor's future

However, there are two points to grasp, Alexandre said. First, patients responded particularly well to the placebo plus standard of care because the cortical steroids worked. Second, the drug actually worked well in certain patient groups.

READ: Today's news

“We need to see more data,” Alexandre said. “There is a major unmet medical need and there has only been one drug out in the market in the last 50 years and that itself is not a perfect drug.”

On the news ImmuPharma is talking to potential partners, the Northland analyst added: “The primary end-point has not been met, but I think they will be looking at what the possibilities are for doing further and future trials.”

 

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Tue, 17 Apr 2018 14:55:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195172/immupharma-drug-needs-further-analysis-it-could-still-have-a-role-in-treating-lupus-city-analyst-195172.html
<![CDATA[News - ImmuPharma sees "significant opportunity" for lupus drug after phase III trial readout ]]> https://www.proactiveinvestors.co.uk/companies/news/195121/immupharma-sees-significant-opportunity-for-lupus-drug-after-phase-iii-trial-readout-195121.html ImmuPharma PLC (LON:IMM) said it believes there is a “significant opportunity” for its drug Lupuzor, used to treat autoimmune disease lupus, following the release of top-line results from a phase III trial.

The data revealed Lupuzor was more effective than the placebo (52.5% versus 44.6%). But because the response rate for those taking the non-active medication plus the “standard of care” was so high the end-point of the study was not achieved. That 'end-point' was a statistically significant beneficial impact from Lupuzor.

This initial readout was based on 202 patients, including those who withdrew from the trial.

WATCH: Drug needs further analysis, City analyst

The effectiveness among the 153 that got to the end of the course of treatment was 68.8% (versus 59.2% for the placebo).

Importantly, in patients who had a certain type of lupus biomarker called anti-dsDNA autoantibodies, Lupuzor worked well when compared with the placebo. Added to that, 7.6% of this group went into full remission, while none did in the placebo group.

The safety profile remained good with no adverse effects

Chairman Tim McCarthy said: “Lupuzor has demonstrated, in this study, a superior response rate over placebo and its exceptional safety, giving it, we believe, a compelling product profile.

“Whilst we are disappointed at the high response in the placebo plus standard of care group that resulted in statistical significance not being reached between the two treatment groups, we believe Lupuzor has the potential to bring a much needed safe treatment to the millions of Lupus sufferers around the world.

“We look forward to providing our shareholders with further updates in due course."

Further investigation merited

ImmuPharma said it believes the top line results “provide evidence for the continued investigation into the development and commercialisation of Lupuzor”. It thinks the drug has the potential to offer patients and physicians a much needed effective and safe treatment for lupus.

Following requests from both investigators and patients, ImmuPharma has begun a further study. This will allow all patients who took part in the phase III trial to receive Lupuzor plus the ‘standard of care’ medication for six months in what’s called an open-label scheme.

The results will be gathered independent of the pivotal trial just completed.

The plan is to look at the full dataset before making a decision, but the company said there is demand for a new lupus treatment.

Expressions of interest

It also said there had been “expressions of interest” in the Lupuzor programme and the phase III study.

“ImmuPharma is in ongoing discussions with a number of larger pharmaceutical companies,” it added.

“The results of this study will now be shared with those potential commercial partners. There can be no certainty as to the outcome or timing of these discussions.”

The shares fell 76%.

----adds share price---

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Tue, 17 Apr 2018 07:31:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195121/immupharma-sees-significant-opportunity-for-lupus-drug-after-phase-iii-trial-readout-195121.html
<![CDATA[RNS press release - Topline results of Lupuzor Pivotal Phase III Trial ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180417070005_13606648/ Tue, 17 Apr 2018 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180417070005_13606648/ <![CDATA[RNS press release - Appointment of Joint Broker ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180328070007_13584105/ Wed, 28 Mar 2018 07:00:07 +0100 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180328070007_13584105/ <![CDATA[News - ImmuPharma passes significant milestone; expects top line phase III data on flagship drug by the middle of next month ]]> https://www.proactiveinvestors.co.uk/companies/news/193677/immupharma-passes-significant-milestone-expects-top-line-phase-iii-data-on-flagship-drug-by-the-middle-of-next-month-193677.html ImmuPharma PLC (LON:IMM) said the database lock of its phase III clinical trial of Lupuzor, for the autoimmune disease lupus, is expected on April 6.

This is a significant milestone. It denotes the end of the pivotal study, but also prevents unauthorised or unintended changes to the information garnered.

This particularly important when the drug assessment is double-blind, which simply means the physicians don’t know whether patients are receiving the drug or a placebo with no medical benefits.

For more a fuller explanation of database lock, click here

Top-line results from the trial are expected by mid-April, ImmuPharma said after being updated by Simbec-Orion, the contract research firm carrying out the work.

Chairman Tim McCarthy said: "With the continued robust safety record of Lupuzor achieved over this trial, we look forward with confidence to reporting top line results in the near future."

A total of 200 lupus patients took part in the study, which it is hoped will provide a breakthrough for sufferers.

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

Strong cash position

According to the Lupus Foundation of America, around 1.5mln in the States have the condition, with 90% of those estimated to be women.

In a note to clients, analysts at ‘house’ broker Northland Capital said a £10mln raise completed in January, ImmuPharma is in a strong cash position.

“Should Lupuzor successfully meet the trial endpoints, the company will be in a strong negotiating position with potential partners,” it added.

Northland repeated its ‘buy’ rating and 181p target price on the stock.

In late afternoon trading, Immupharma shares were 2.4% lower at 124.5p.

 -- Adds broker comment, share price --

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Fri, 23 Mar 2018 07:24:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/193677/immupharma-passes-significant-milestone-expects-top-line-phase-iii-data-on-flagship-drug-by-the-middle-of-next-month-193677.html
<![CDATA[RNS press release - Lupuzor Pivotal Phase III Study Update ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180323070004_13578412/ Fri, 23 Mar 2018 07:00:04 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180323070004_13578412/ <![CDATA[RNS press release - AIM Notice (17) ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180305161338_13555318/ Mon, 05 Mar 2018 16:13:38 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180305161338_13555318/ <![CDATA[RNS press release - London Investor Evening ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180215070006_13533834/ Thu, 15 Feb 2018 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180215070006_13533834/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180209140002_13528385/ Fri, 09 Feb 2018 14:00:02 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180209140002_13528385/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180207093546_13524636/ Wed, 07 Feb 2018 09:35:46 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180207093546_13524636/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180205070005_13520841/ Mon, 05 Feb 2018 07:00:05 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180205070005_13520841/ <![CDATA[Media files - Exciting start to 2018 for ImmuPharma with pivotal data 'weeks away' ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/8696/exciting-start-to-2018-for-immupharma-with-pivotal-data-weeks-away--8696.html Fri, 02 Feb 2018 13:25:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/8696/exciting-start-to-2018-for-immupharma-with-pivotal-data-weeks-away--8696.html <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180131102314_13516168/ Wed, 31 Jan 2018 10:23:14 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180131102314_13516168/ <![CDATA[News - ImmuPharma says it received strong institutional backing for £10mln City fundraiser ]]> https://www.proactiveinvestors.co.uk/companies/news/190525/immupharma-says-it-received-strong-institutional-backing-for-10mln-city-fundraiser-190525.html ImmuPharma PLC (LON:IMM) said it received strong backing from existing and new institutional investors for its £10mln City fundraiser.

The cash, raised by issuing shares at 144p each, will support future investment in the P140 peptide platform. It will also be used to meet the drug developer’s working capital requirements.

READ: ImmuPharma confident of topline results from Phase III Lupuzor trial this quarter

P140 is the bedrock for the company’s lead product, Lupuzor, on which a phase III clinical study was recently completed. Investors expect an initial read-out from the trial later this quarter.

Investment for the next period of growth

"We were approached by new institutions, introduced by Turner Pope Investments, keen to support ImmuPharma over the next period of growth,” said chairman Tim McCarthy of the additional funding.

ImmuPharma confirmed last week it had completed the pivotal phase III study of its Lupuzor, for the autoimmune disease lupus, leaving it on track to publish top-line data from the trial in the current quarter.

The last of the 200 patients recently attended their final assessment and data from the trial is being collected, checked and analysed.

AIM-quoted ImmuPharma said Lupuzor demonstrated a “robust safety profile” during the 12 month long trial, in keeping with what was seen in the successful phase IIb study.

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Wed, 24 Jan 2018 07:53:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/190525/immupharma-says-it-received-strong-institutional-backing-for-10mln-city-fundraiser-190525.html
<![CDATA[RNS press release - Successful Placing to Raise £10 Million ]]> https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180124070004_13507061/ Wed, 24 Jan 2018 07:00:04 +0000 https://www.proactiveinvestors.co.uk/companies/rns/463/LSE20180124070004_13507061/