Proactiveinvestors United Kingdom Motif Bio PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Motif Bio PLC RSS feed en Fri, 19 Jul 2019 08:43:33 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[RNS press release - Motif Bio-Receipt of Deficiency Notice from Nasdaq ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190719070002_14155466/ Fri, 19 Jul 2019 07:00:02 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190719070002_14155466/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190718163046_14155201/ Thu, 18 Jul 2019 16:30:46 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190718163046_14155201/ <![CDATA[News - Motif Bio PLC requests meeting with US regulator to discuss trial design ]]> https://www.proactiveinvestors.co.uk/companies/news/223871/motif-bio-plc-requests-meeting-with-us-regulator-to-discuss-trial-design-223871.html Motif Bio PLC (LON:MTFB) has requested a second meeting with the US drug regulator as part of its bid to win marketing approval for its antibiotic, iclaprim.

The company has been asked by the Food & Drug Administration to perform a further clinical trial before it signs off the drug.

Motif therefore wants to arrange what’s called a Type-B meeting with the watchdog to discuss just which types of patient will take part in the new study along with its design.

It typically takes around 60 days from the time of request to schedule a face to face of this kind.

Along with the request, the company has also submitted an information package.

Motif chief executive Graham Lumsden said: “As we continue our discussions with potential US commercial partners and evaluate potential funding options for the iclaprim clinical programme, we expect to gain greater clarity from the Agency during the Type-B meeting on the pathway forward for iclaprim."

The FDA in an earlier discussion encouraged Motif to carry out a further trial to allay concerns over liver toxicity, which emerged following the submission of trial data from two phase III assessments of the drug.

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Mon, 15 Jul 2019 07:24:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/223871/motif-bio-plc-requests-meeting-with-us-regulator-to-discuss-trial-design-223871.html
<![CDATA[RNS press release - US FDA meeting request and package submitted ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190715070004_14148474/ Mon, 15 Jul 2019 07:00:04 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190715070004_14148474/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190628171306_14129964/ Fri, 28 Jun 2019 17:13:06 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190628171306_14129964/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190628164058_14129907/ Fri, 28 Jun 2019 16:40:58 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190628164058_14129907/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190628163604_14129893/ Fri, 28 Jun 2019 16:36:04 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190628163604_14129893/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190626120748_14125562/ Wed, 26 Jun 2019 12:07:48 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190626120748_14125562/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190626120232_14125546/ Wed, 26 Jun 2019 12:02:32 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190626120232_14125546/ <![CDATA[News - Motif Bio presents new iclaprim data at industry conference in California ]]> https://www.proactiveinvestors.co.uk/companies/news/222643/motif-bio-presents-new-iclaprim-data-at-industry-conference-in-california-222643.html Motif Bio PLC (LON:MTFB) has released new data for its iclaprim antibiotic at a major industry conference in San Francisco, California.

The AIM- and Nasdaq-listed biopharma presented three posters at the American Society for Microbiology (ASM) Microbe 2019 meeting over the weekend.

READ: US drugs regulator encourages Motif to carry further icalprim study

The first presentation focused on dosage, with data showing that the 80mg fixed doses given to patients in the most recent REVIVE phase III trial were more efficacious than the weight-based doses given in earlier studies.

“The fixed dose regimen may help reduce the resources required in hospitals, since dosage adjustment by clinicians is avoided, and overall treatment costs may be lower, especially in patients with obesity or renal impairment,” said Motif.

A second poster highlighted the diverse patient population in the REVIVE and earlier ASSIST phase III studies.

In total, 1,093 patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) were treated with icplarim in the studies, with older patients and those with co-morbidities such as obesity, diabetes and renal impairment were “well-represented”.

In the REVIVE and ASSIST trials, respectively:  12% and 16% of patients treated with iclaprim were 65 or older; 15% and 8% were obese; 9% and 12% had diabetes; and 15% and 41% had renal impairment.

Antibiotic resistance a major global issue

In the third poster, Motif showed off iclaprim’s “potent activity” against various Gram-positive multi-drug resistant streptococci – the bacteria that can cause disorders such as pneumonia.

Streptococci is known for its resistance to azithromycin, clindamycin and tetracycline – three of the most common antibiotics currently used to fight bacterial infections.

“Given the growing public health concern about antibiotic resistance, it is important to continue to monitor the activity of iclaprim against these bacteria,” Motif added.

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Mon, 24 Jun 2019 07:45:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/222643/motif-bio-presents-new-iclaprim-data-at-industry-conference-in-california-222643.html
<![CDATA[RNS press release - Motif Bio Presents New Iclaprim Data - ASM Microbe ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190624070013_14120921/ Mon, 24 Jun 2019 07:00:13 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190624070013_14120921/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190620163558_14118926/ Thu, 20 Jun 2019 16:35:58 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190620163558_14118926/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190619170826_14117315/ Wed, 19 Jun 2019 17:08:26 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190619170826_14117315/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190618160547_14115560/ Tue, 18 Jun 2019 16:05:47 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190618160547_14115560/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190614090454_14111319/ Fri, 14 Jun 2019 09:04:54 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190614090454_14111319/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190612175228_14108843/ Wed, 12 Jun 2019 17:52:28 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190612175228_14108843/ <![CDATA[News - Motif Bio says US drugs regulator has encouraged it to carry out further study on antibiotic ]]> https://www.proactiveinvestors.co.uk/companies/news/221611/motif-bio-says-us-drugs-regulator-has-encouraged-it-to-carry-out-further-study-on-antibiotic-221611.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB) said the US drug regulator has encouraged the company to carry out a further trial on its antibiotic to allay concerns over possible liver toxicity.

At the moment it’s unclear what form the additional assessment will take. The company, in an update, said it had requested a meeting with US Food & Drug Administration to discuss the design of the fresh clinical evaluation, including the appropriate patient population.

Motif is developing iclaprim to treat acute bacterial skin and skin structure infections, and the interaction with the drugs watchdog follows the completion of a phase III trial.

Initial feedback

Initial feedback came in the form of a complete response letter following the trial and then from the minutes of a meeting with the FDA on May 3.

Motif chief executive Graham Lumsden said he thought the drug had a future as he mapped out the next steps, while confirming talks with potential commercial partners were ongoing.

“We intend to meet with the agency to agree on the specific requirements of the trial, which will enable us to estimate its size and scope and, therefore, the costs and funding requirements,” he explained.

Potential alternative indications

As well as a potential new treatment for hospitalised people with acute skin infections, iclaprim could be developed for use in patients with cystic fibrosis or in ophthalmology under what’s called an orphan indication, CEO Lumsden said.

“Completing the steps necessary to provide the additional trial data to respond to the complete response letter is our top priority,” he added.

“We are also continuing our business development activities to position Motif Bio for long-term growth by building a robust development pipeline.

“In parallel with our focus on iclaprim, we continue to pursue a variety of attractive opportunities in the anti-infectives space, as well as in other key therapeutic areas."

In an update on its finances, the company said it had a cash runway “into September”. Unsurprisingly then, it said it is looking to secure additional cash either via an equity raise through other non-dilutive sources.

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Thu, 06 Jun 2019 07:37:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/221611/motif-bio-says-us-drugs-regulator-has-encouraged-it-to-carry-out-further-study-on-antibiotic-221611.html
<![CDATA[RNS press release - Receipt of FDA Meeting Minutes ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190606070007_14100505/ Thu, 06 Jun 2019 07:00:07 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190606070007_14100505/ <![CDATA[RNS press release - Result of AGM ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190531151504_14094653/ Fri, 31 May 2019 15:15:04 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190531151504_14094653/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190531102845_14094102/ Fri, 31 May 2019 10:28:45 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190531102845_14094102/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190529113652_14090973/ Wed, 29 May 2019 11:36:52 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190529113652_14090973/ <![CDATA[Media files - Motif Bio's Graham Lumsden updates on FDA discussions and iclaprim potential ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13472/motif-bio-s-graham-lumsden-updates-on-fda-discussions-and-iclaprim-potential-13472.html Fri, 24 May 2019 08:48:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/13472/motif-bio-s-graham-lumsden-updates-on-fda-discussions-and-iclaprim-potential-13472.html <![CDATA[News - Motif Bio boss “very confident” in potential of flagship antibiotic ]]> https://www.proactiveinvestors.co.uk/companies/news/220805/motif-bio-boss-very-confident-in-potential-of-flagship-antibiotic-220805.html Motif Bio PLC (LON:MTFB) boss Graham Lumsden is “very confident” in the potential of iclaprim, the drug developer’s next-generation antibiotic.

Iclaprim has already gone through clinical trials as a potential treatment for acute bacterial skin and skin structure infections (ABSSSI).

WATCH: Motif Bio's Graham Lumsden updates on FDA discussions and iclaprim potential

AIM-quoted Motif is currently trying to get US regulators to approve the antibiotic, although they have so far declined to do so, citing the need for additional data on liver toxicity.

Bosses met with Food and Drug Administration officials at the beginning of the month (May) to chart the next steps in the process, and feedback is expected in early June.

Motif has acknowledged that additional data will “likely be required to address the agency’s concern about a risk of liver toxicity”, although it will wait to hear what the FDA has to say before deciding the size and scope of any study.

The plan remains to win marketing approval in the US and then find a partner to help commercialise iclaprim in the States and other global markets.

The company said it is "sufficiently funded" to reach a decision point regarding iclaprim based on the outcome of its meeting with the FDA. Beyond that, it will look at its options to determine the "funding strategy that is most favourable to shareholders".

More than one string to iclaprim’s bow

Some other opportunities have presented themselves of late, though.

Motif has partnered up with Lamellar Biomedical to explore the use of iclaprim as part of a combination treatment for lung infections in people with cystic fibrosis.

The pair will carry out an in vivo study evaluating iclaprim in combination with LMS-611, one of Lamellar’s drugs that has mucus-clearing properties and can boost the performance of antibiotics.

Based on the data from each drug so far, the companies believe combining the two could create a “promising potential treatment” for CF patients with lung infections.

On top of that, Motif thinks its antibiotic has potential as a treatment for toxoplasma chorioretinitis, a rare blindness-causing disease.

It has signed an agreement with the Otto-von-Guericke University Magdeburg in Germany which is to carry out a series of lab tests to see if iclaprim can help people affected by toxoplasma chorioretinitis.

READ: Motif Bio to see if iclaprim can help patients with rare eye disease

“We are very confident in our lead compound Iclaprim's broad potential as a differentiated and targeted anti-infective agent, based on the strong clinical safety and efficacy data we have generated and the important unmet medical and health-economic needs we believe Iclaprim may fulfill within the hospital-based antibiotic landscape and other indications,” said CEO Lumsden.

“In addition to pursuing our first potential approval and commercial partnership for Iclaprim, we are committed to maximizing opportunities to further expand the value of this asset.

“We recently announced two collaborative agreements to evaluate Iclaprim's ability to address high-need orphan diseases within lung disease and ophthalmology.”

Shares were down 6.8% to 6.9p on Wednesday afternoon.

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Wed, 22 May 2019 15:14:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/220805/motif-bio-boss-very-confident-in-potential-of-flagship-antibiotic-220805.html
<![CDATA[RNS press release - AGM Statement ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190522135003_14083870/ Wed, 22 May 2019 13:50:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190522135003_14083870/ <![CDATA[News - Motif Bio teams up with German university to see if iclaprim can help patients with rare eye disease ]]> https://www.proactiveinvestors.co.uk/companies/news/220750/motif-bio-teams-up-with-german-university-to-see-if-iclaprim-can-help-patients-with-rare-eye-disease-220750.html Motif Bio PLC (LON:MTFB) is to explore the possibility of using its iclaprim next-generation antibiotic to treat people with a rare blindness-causing disease called toxoplasma chorioretinitis.

AIM-quoted Motif has tested iclparim in patients with acute bacterial skin and skin structure infections (ABSSSI), for which it is now looking to get regulatory approval.

READ: Motif bosses meet with FDA

But the company has today signed an agreement with the Otto-von-Guericke University Magdeburg in Germany which is to carry out a series of lab tests to see if iclaprim can help people affected by toxoplasma chorioretinitis.

The orphan disease that is a type of ocular toxoplasmosis – a parasitic disease that may result in severe life-threatening infections and/or blindness.

The work will be carried out by professor Ildiko Rita Dunay, a director at the university’s Institute of Inflammation and Neurodegeneration.

“We are very pleased to work with Dr Dunay, who is an expert in the area of toxoplasmosis. In vitro data indicate that iclaprim has activity against toxoplasma,” said chief medical officer David Huang.

“The data generated from Dr Dunay's lab will be important in understanding whether iclaprim can play a role in this potentially devastating, progressive and recurring necrotizing retinitis, including vision-threatening complications.”

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Wed, 22 May 2019 07:50:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/220750/motif-bio-teams-up-with-german-university-to-see-if-iclaprim-can-help-patients-with-rare-eye-disease-220750.html
<![CDATA[RNS press release - Orphan Disease Opportunity for Iclaprim ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190522070006_14082732/ Wed, 22 May 2019 07:00:06 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190522070006_14082732/ <![CDATA[News - Motif Bio to present three iclaprim posters at industry conference in San Francisco next month ]]> https://www.proactiveinvestors.co.uk/companies/news/220653/motif-bio-to-present-three-iclaprim-posters-at-industry-conference-in-san-francisco-next-month-220653.html UK biopharma Motif Bio PLC (LON:MTFB) is to present three posters on its iclaprim next-generation antibiotic at an upcoming industry conference in San Francisco.

The American Society for Microbiology (ASM) Microbe 2019 meeting runs from 20 to 24 June. Motif bosses will be presenting their posters on 21 and 22 June.

READ: Motif bosses meet with FDA

AIM- and Nasdaq-listed Motif met with the US Food and Drug Administration (FDA) earlier this month as it looks to secure regulatory approval for iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).

The company sought talks after the FDA declined to give the antibiotic the green light, citing in a document the need for additional data on liver toxicity.

As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’. The firm has always said it was keen to discuss potential deficiencies with the information provided.

The latest meeting, which took place on 3 May, offered that chance, with feedback expected within 30 days.

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Tue, 21 May 2019 07:54:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/220653/motif-bio-to-present-three-iclaprim-posters-at-industry-conference-in-san-francisco-next-month-220653.html
<![CDATA[RNS press release - Iclaprim Data presented at ASM Microbe 2019 ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190521070025_14081007/ Tue, 21 May 2019 07:00:25 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190521070025_14081007/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190520181422_14080784/ Mon, 20 May 2019 18:14:22 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190520181422_14080784/ <![CDATA[News - Motif Bio meets FDA ]]> https://www.proactiveinvestors.co.uk/companies/news/219763/motif-bio-meets-fda-219763.html Motif Bio PLC (LON:MTFB, NASDAQ:MTFB) is expected to be able to chart a “path forward” for its lead drug iclaprim in the next month after a meeting with the US regulator went ahead as planned.

The company sought talks after the Food & Drug Administration declined to give the antibiotic the green light, citing in a document the need for additional data on liver toxicity.

As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’.The firm has always said it was keen to discuss potential deficiencies with the information provided.

The latest meeting offered that chance, with feedback expected in the next 30 days.

“After Motif Bio has received the [FDA’s] minutes, the company will be in a position to provide an update to the market on the path forward for iclaprim,” the company said in a short investor update.

iclaprim is being developed as a treatment for acute skin infection.

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Tue, 07 May 2019 07:39:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219763/motif-bio-meets-fda-219763.html
<![CDATA[RNS press release - Meeting with US FDA held as planned ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190503182503_14063296/ Fri, 03 May 2019 18:25:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190503182503_14063296/ <![CDATA[News - Motif Bio partners up with Scottish biotech to develop iclaprim as cystic fibrosis lung infection treatment ]]> https://www.proactiveinvestors.co.uk/companies/news/219454/motif-bio-partners-up-with-scottish-biotech-to-develop-iclaprim-as-cystic-fibrosis-lung-infection-treatment-219454.html Motif Bio PLC (LON:MTFB) shares gained on Wednesday as the firm revealed that it has partnered up with Scottish biotech Lamellar Biomedical to develop a treatment for lung infections in patients with cystic fibrosis (CF).

AIM-quoted Motif already owns a next generation antibiotic called iclaprim, while Lamellar’s LMS-611 is known to have mucus-clearing properties and has been shown to boost the performance of antibiotics.

READ: Motif Bio seeks talks with US drugs regulator

Iclaprim has been granted orphan drug designation in the US for Staphylococcus aureus pneumonia in patients with CF, and LMS-611 has a European orphan drug designation for the disorder.

Based on the data from each drug so far, the companies believe combining the two could create a “promising potential treatment” for CF patients with lung infections.

As part of the tie-up, Motif Bio will carry out an in vivo study evaluating iclaprim in combination with LMS-611.

“We have been looking for a way to optimise the development of iclaprim in patients with CF,” said chief executive Motif Bio.

“We are excited about the preliminary data we have seen with Lamellar's technology and look forward to evaluating it in combination with iclaprim.”

In afternoon trading, shares in Motif Bio were 7.6% higher at 9.34p.

In a note to clients, analysts at ‘house’ broker Peel Hunt commented: “This is an incremental positive for iclaprim, reminding investors of its wider potential as an antibiotic but – as a reminder – we await Motif’s perspective following the FDA meeting on 3 May in respect of icalprim’s CRL for ABSSSI (14th Feb) and, perhaps more importantly, the receipt of the meeting minutes expected c30 days afterwards (c3 June).”

 -- Adds analyst comment, updates share price --

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Wed, 01 May 2019 08:45:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219454/motif-bio-partners-up-with-scottish-biotech-to-develop-iclaprim-as-cystic-fibrosis-lung-infection-treatment-219454.html
<![CDATA[RNS press release - Motif Signs Agreement with Lamellar Biomedical ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190501070014_14058482/ Wed, 01 May 2019 07:00:14 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190501070014_14058482/ <![CDATA[RNS press release - Notice of AGM ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070103_14052824/ Fri, 26 Apr 2019 07:01:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070103_14052824/ <![CDATA[RNS press release - Appointment of Andrew Powell to Board of Directors ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070011_14052781/ Fri, 26 Apr 2019 07:00:11 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190426070011_14052781/ <![CDATA[News - Motif Bio higher as it presents data from Phase III iclaprim trial ]]> https://www.proactiveinvestors.co.uk/companies/news/218650/motif-bio-higher-as-it-presents-data-from-phase-iii-iclaprim-trial-218650.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB) shares rose on Tuesday as the firm delivered new data on its lead drug, iclaprim, at the European Congress of Clinical Microbiology and Infectious Diseases, in Amsterdam.

The presentation provided a drill-down into the results from the company’s REVIVE Phase III study of people with skin and skin structure infections.

READ: Motif Bio receives vote of confidence as it raises £2.7mln

Among the headlines was an analysis by lesion size, which showed the antibiotic had comparable efficacy to vancomycin, the current standard of care.

Delegates heard the bacteremia rates were comparable between the two drugs, while the pharmacokinetics of iclaprim (the way the drug moves around the body) supported the use of a fixed dosing regimen.

Finally, Motif provided details of a recent lab-based data supporting iclaprim’s activity against Gram-positive bacteria collected from patients.

“Data are being presented that show that iclaprim continues to be active against a variety of antibiotic-resistant pathogens like methicillin-resistant (MRSA), methicillin-susceptible (MSSA) Staphylococcus aureus, and other Gram-positive skin and soft structure pathogens collected during 2017 from Europe and the US,” Motif said.

In early afternoon trading in London, Motif Bio shares were 4.9% higher at 8.82p.

 -- Adds share price --

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Tue, 16 Apr 2019 07:46:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218650/motif-bio-higher-as-it-presents-data-from-phase-iii-iclaprim-trial-218650.html
<![CDATA[RNS press release - Motif Presents New Iclaprim Data at ECCMID 2019 ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190416070015_14042103/ Tue, 16 Apr 2019 07:00:15 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190416070015_14042103/ <![CDATA[News - Motif Bio still hopeful of reaping the benefit from a productive year ]]> https://www.proactiveinvestors.co.uk/companies/news/218554/motif-bio-still-hopeful-of-reaping-the-benefit-from-a-productive-year-218554.html Securing approval in the US for iclaprim remains the top priority for Motif Bio PLC (LON:MTFB), the company said in its full-year results statement.

The company, which is scheduled to meet the US Food and Drug Administration (FDA) in early May to discuss concerns over the risk of liver toxicity for patients taking iclaprim, stressed that securing US approval is but part of a broader plan for iclaprim's long-term success.

READ: Motif Bio receives vote of confidence as it raises £2.7mln

“We expect to be joined at the meeting by two external experts and anticipate a collaborative discussion and hopefully an acceptable path forward. We believe that iclaprim can be a valuable option for patients and their providers who are in need of new antibiotic treatment options,” said Dr Graham Lumsden, the chief executive officer of Motif.

In the meantime, the company is keeping a tight watch on costs, having posted a sharply reduced loss of US$14.0mln for 2018 compared to a loss of US$44.8mln in 2017.

Research and development expenses decreased to US$11.0mln from US$29.5mln in 2017. This decrease was primarily attributable to a US$22.1 million reduction in expense for the iclaprim Phase III clinical trial programme, which was completed in 2017, although this was partially offset by a US$3.6mln increase in costs relating to regulatory and clinical operating activities, chemistry manufacturing and control requirements and other non-clinical development activities.

Cash and cash equivalents stood at around US$12.3mln at the end of 2018; since then, the company has raised US$3.3mln through a share issue.

Way forward for iclaprim

As previously mentioned, the company has enough money to get it beyond the meeting with the FDA next month and tide it over while it formulates a plan for the way forward for iclaprim after the meeting.

In a note to clients, analysts at ‘house’ broker Peel Hunt pointed out: “Our forecasts, recommendation and TP remain U/R and we await the company’s perspective following the FDA meeting on 3 May where it will discuss the points raised in the complete response letter (received 14 February) for iclaprim’s NDA.”

They added: “We note that the company has previously described that – assuming a viable route to approval can be found beyond the FDA meeting – it expects further funds to be required to resubmit an NDA, meet all obligations and reach a new approval date.”

In afternoon trading, Motif Bio shares were trading at 8.68p, down 1% on Friday’s close.

 -- Adds analyst comment, share price --

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Mon, 15 Apr 2019 07:39:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218554/motif-bio-still-hopeful-of-reaping-the-benefit-from-a-productive-year-218554.html
<![CDATA[RNS press release - Fiscal Year 2018 Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190415070007_14040326/ Mon, 15 Apr 2019 07:00:07 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190415070007_14040326/ <![CDATA[RNS press release - Motif Bio to Present Iclaprim Data at ECCMID 2019 ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190404070013_14028240/ Thu, 04 Apr 2019 07:00:13 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190404070013_14028240/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190402174355_14026227/ Tue, 02 Apr 2019 17:43:55 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190402174355_14026227/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401152807_14024074/ Mon, 01 Apr 2019 15:28:07 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401152807_14024074/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401141735_14023907/ Mon, 01 Apr 2019 14:17:35 +0100 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190401141735_14023907/ <![CDATA[News - Motif Bio receives vote of confidence as it raises £2.7mln ]]> https://www.proactiveinvestors.co.uk/companies/news/217201/motif-bio-receives-vote-of-confidence-as-it-raises-27mln-217201.html Motif Bio PLC (LON:MTFB, NASDAQ:MTFB) received a monetary boost – and by extension a vote of confidence in its prospects – as it raised £2.7mln via a share placing.

The cash will fund the business through the coming months as it meets with officials at the US Food & Drug Administration (FDA) to discuss the future of its antibiotic, iclaprim.

The treatment, which was developed to tackle acute bacterial skin infections, was knocked by the FDA last month.

The watchdog wants additional data so it can “further evaluate the risk for liver toxicity” before it decides whether or not to grant new drug approval. As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’. So there may still be some hope.

Of course, Motif is keen “to discuss potential options to address the deficiencies” with the information it had furnished. But ahead of the fundraiser, there had been real concerns the business might run out of cash.

Meeting scheduled

A meeting with the FDA is scheduled for May 3, and the company expects a response a month later.

Proceeds from the placing, which was completed at 6p a share, will provide a financial runway long enough to see it past the date it receives the minutes from the regulator in June.

Chief executive Graham Lumsden said: "We are encouraged by the support shown by both new and existing investors as we strengthen our balance sheet.

“The company now expects to be funded through completion of the FDA meeting and receipt of the minutes, which should provide guidance regarding the path forward for iclaprim."

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Tue, 26 Mar 2019 08:10:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/217201/motif-bio-receives-vote-of-confidence-as-it-raises-27mln-217201.html
<![CDATA[RNS press release - Motif Bio Raises £2.7m (US$3.55m) ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190326070017_14015167/ Tue, 26 Mar 2019 07:00:17 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190326070017_14015167/ <![CDATA[News - Motif Bio PLC says it is in the advanced stages of concluding a proposed placing to institutional and other investors ]]> https://www.proactiveinvestors.co.uk/companies/news/217110/motif-bio-plc-says-it-is-in-the-advanced-stages-of-concluding-a-proposed-placing-to-institutional-and-other-investors-217110.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB) has confirmed that it needs to raise additional capital in the near term and said it is in the advanced stages of concluding a proposed placing of new ordinary shares to institutional and other investors.

The AIM-listed clinical-stage biopharmaceutical company, specialising in developing novel antibiotics, said the net proceeds of the proposed placing, when taken together with its existing cash resources are expected to be sufficient to fund the business beyond its meeting with the US Food & Drug Administration (FDA) scheduled for 3 May 2019.

READ: Motif Bio surges as US FDA agrees to a meeting to discuss new drug application for novel antibiotic iclaprim

At that meeting, Motif Bio will discuss the Complete Response Letter received in respect of the company's New Drug Application (NDA) for its lead novel antibiotic, iclaprim, which said additional data was needed.

The company said it expects to be able to provide guidance as to a route to approval for iclaprim upon receipt of the minutes from this meeting, which would typically be approximately 30 days from the meeting date.

The group added that assuming a viable route to approval, it is expected that further additional funds will be required to resubmit an NDA and reach a new approval date.

Motif Bio concluded: “Whilst there can be no certainty that the Proposed Placing will proceed, nor as to the quantum, pricing, or timing of any such placing the Board is seeking to conclude the process shortly and will update shareholders accordingly.”

In mid-morning trading, Motif Bio shares were 4.6% lower at 7.50p.

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Mon, 25 Mar 2019 10:06:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/217110/motif-bio-plc-says-it-is-in-the-advanced-stages-of-concluding-a-proposed-placing-to-institutional-and-other-investors-217110.html
<![CDATA[RNS press release - Proposed Equity Fundraise ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190325094953_14014125/ Mon, 25 Mar 2019 09:49:53 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190325094953_14014125/ <![CDATA[News - Motif Bio surges as US FDA agrees to a meeting to discuss new drug application for novel antibiotic iclaprim ]]> https://www.proactiveinvestors.co.uk/companies/news/216830/motif-bio-surges-as-us-fda-agrees-to-a-meeting-to-discuss-new-drug-application-for-novel-antibiotic-iclaprim-216830.html Motif Bio PLC (LON:MTFB) (NASDAQ:MTFB), saw its shares surge on Wednesday after the biopharmaceutical company said the US Food & Drug Administration (FDA) has agreed to a meeting to discuss its need for additional data related to the new drug application for Motif’s novel antibiotic, iclaprim

The AIM-listed firm said the meeting with the US watchdog is scheduled to take place on 3 May 2019, with official meeting minutes typically received from the FDA within 30 days of a meeting. 

READ: Motif Bio seeks talks with FDA after iclaprim setback

After this, Motif Bio said it will be in a position to provide an update to the market on the path forward for iclaprim, which has been developed for the treatment of acute bacterial skin and skin structure infections.

Graham Lumsden, Motif Bio’s chief executive officer said:  "We are pleased that the FDA has granted our meeting request and that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts.

“We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval."

Financing

As previously announced, the company also reaffirmed that it needs to raise additional capital in the near term, with a further update regarding financing to be made in due course.

In early afternoon trading in London, Motif Bio shares were 52% higher at 9.00p.

The company said on 14 February that it had requested a meeting after the FDA said it wouldn’t be giving the regulatory green light to the company’s antibiotic, iclaprim.

In what is called a complete response letter, the FDA indicated additional data would be required “to further evaluate the risk for liver toxicity” before granting approval.

 -- Updates share price --

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Wed, 20 Mar 2019 09:51:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/216830/motif-bio-surges-as-us-fda-agrees-to-a-meeting-to-discuss-new-drug-application-for-novel-antibiotic-iclaprim-216830.html
<![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070010_14008316/ Wed, 20 Mar 2019 07:00:10 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070010_14008316/ <![CDATA[RNS press release - Motif Bio Granted Meeting with U.S. FDA ]]> https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070006_14008292/ Wed, 20 Mar 2019 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/10670/LSE20190320070006_14008292/