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.
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.”
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.