ImmuPharma upbeat after meeting with US partner Avion

11th Nov 2022 13:04

(Sharecast News) - Drug discovery and development specialist ImmuPharma updated the market on a recent meeting in Atlanta with its United States partner Avion Pharmaceuticals on Friday, for strategic discussions around its 'Lupuzor' clinical programme.

The AIM-traded firm said Avion confirmed its support for the Lupuzor clinical programme in lupus at the meeting, following the receipt of a written response from the US Food and Drug Administration (FDA) to the 'type C' meeting in September.

In its written response, the FDA provided "significant and extremely valuable" guidance on the study protocol, that could be amended, to improve the regulatory outcome.

The board said it primarily focussed on a recommendation to explore higher dosing levels, given the robust safety profile of Lupuzor, than were used in the clinical programme so far, to enhance the probability of meeting the primary endpoint of statistically significant efficacy.

ImmuPharma and Avion, together with external advisors, were now preparing a proposed updated clinical programme.

The company said the update was considering either a phase 2 dose ranging study to identify the optimum dose level, followed by a phase 3 study with that optimum dose, or alternatively a phase 2 and 3 adaptive study which would encompass the same dose ranging within one continuous study.

It said the chosen route would be agreed with the FDA, with further details on the study design and progress to be communicated once the FDA was consulted and a response provided.

ImmuPharma said it also agreed to explore the opportunity of a mutually-beneficial route to allow ImmuPharma to introduce certain Avion products into the European market.

If that was successful, it would generate top-line product sales revenue for the first time in ImmuPharma's history and contribute net positive cash flow to the company.

In turn, the board said the firm had identified an established European partner that could provide the infrastructure to market and distribute the products.

Discussions were to be progressed as to the legal, regulatory and commercial aspects of such a collaboration, the directors added.

"We have had extremely positive discussions with Avion over the last month and, following receipt of the written response from the FDA, we have agreed to redesign the clinical program for Lupuzor to encompass the recommendations from the FDA, with a view to enhancing the probability of success," said chief executive officer Tim McCarthy.

"In addition, our discussions have developed the potential of a much broader collaboration whereby we would be working in partnership to introduce certain Avion products into the European market."

At 1300 GMT, shares in ImmuPharma were down 13.77% at 2.85p.

Reporting by Josh White for Sharecast.com.