ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said its US partner Avion has confirmed its support for a revised clinical program for lupus treatment Lupuzor and wants to broaden the collaboration between the two companies.
Plans for Lupuzor in the US had to be redrawn after regulator the US Food and Drug Administration (FDA) advised higher dosing levels given the safety profile of the drug.
As a result, ImmuPharma/Avion are now considering either a Phase 2 dose-ranging study to identify the optimum dose level followed by a Phase 3 study based on that or alternatively a Phase 2/3 adaptive study.
The chosen route will be agreed upon with the FDA, the statement said.
In addition, ImmuPharma said discussions have started about introducing some Avion products into the European market.
That “would generate top-line product sales revenue for the first time in its history and contribute net positive cash flow to the company”, it added.
A European group has already been identified to market and distribute the products with discussions over an agreement already underway.
Tim McCarthy, ImmuPharma’s chief executive, said: "We have had extremely positive discussions with Avion over the last month.
“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."