ImmuPharma still banking on Lupuzor even after failed trial

Specialist drug discovery and development company ImmuPharma announced its interim results for the six months ended 30 June on Wednesday - a period in which its revenue remained negligible at £0.07m, but its drug candidate ‘Lupuzor’ demonstrated a superior response rate over placebo in its primary analysis on the full set of 202 patients.

The AIM-traded firm did note that, due to the high response rate in the placebo group, that superior response did not allow statistical significance to be reached, with the trial's primary endpoint not met.

It said that across the whole study population, in those patients who had anti-dsDNA autoantibodies, Lupuzor did demonstrate a superior response rate over placebo.

Although those results were not statistically significant, further data analysis demonstrated that in the Europe cohort of 130 patients, Lupuzor plus standard of care showed statistically significant reductions in disease activity compared to placebo plus standard of care in 79 patients who were anti-dsDNA autoantibody positive.

ImmuPharma said the study confirmed the “outstanding” safety profile of Lupuzor, with no serious adverse events reported.

As it announced on 7 September, an agreement had been signed with a specialist provider to enter Lupuzor into a 'managed access programme'.

Looking at its other programmed, ImmuPharma said its ‘Nucant’ cancer programme had entered a clinical development collaboration with Incanthera, and its peptide platform programme was to be divested via its Ureka subsidiary.

On the financial front, the company completed a £10m fundraising before expenses in January, saying it was in a “stable” financial performance over the period, in line with market expectations.

Net assets stood at £9.9m, up from £3.6m on 31 December, with the loss for the period widening to £4.1m from £3.0m year-on-year.

Research and development expenses grew to £2.5m from £2.3m.

ImmuPharma’s basic and diluted losses per share were 2.94p, compared to 2.34p a year ago.

“It has been a busy period for the Board following the announcement of the Phase III trial results for Lupuzor in April,” said chairman Tim McCarthy.

“We remain focussed on delivering a business strategy which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, resources and knowhow.

“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, McCarthy said the company remained focussed on achieving the full regulatory approval of Lupuzor, which it believed had the potential to be a “groundbreaking” drug for lupus patients with “blockbuster potential” in commercial terms.

“Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years,” he added, saying the board was “equally excited” by the potential of both.

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