One year anniversary of last years RNS10 Nov 2023 08:05
As you can all see so much has happened in 12 months or as Tim likes to now say H1 & H2 of 2023
11 Nov 2022 07:31
RNS Number : 1192G
Immupharma PLC
11 November 2022
11 November 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
Avion confirms its continued support to the Lupuzor™ clinical program in Lupus
whilst exploring broader collaboration opportunities
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to update the market on a recent meeting in Atlanta, USA with our US partner, Avion Pharmaceuticals, LLC ("Avion") for strategic discussions around ImmuPharma's Lupuzor™ clinical program.
This included Avion continuing its support to the clinical program of Lupuzor™ for Lupus, as well as a wider discussion on how the two companies could potentially further collaborate.
Key highlights:
· Lupuzor™ for Lupus clinical program to be redesigned on key protocols following written response from FDA, in order to enhance the probability of success.
· Potential of product sales revenues for ImmuPharma by introducing certain Avion drugs into the European market.
Lupuzor™ for Lupus
At the recent meeting in Atlanta, Avion confirmed its support for the Lupuzor™ clinical program in Lupus. This follows on from the receipt in September of the written response from the Food and Drug Administration ("FDA") to the Type C meeting.
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. This primarily focussed on a recommendation to explore higher dosing levels (given the robust safety profile of Lupuzor™) than have been used in the clinical program to date, to enhance the probability of meeting the primary endpoint of statistically significant efficacy. The ImmuPharma/Avion team, together with external advisors, are preparing a proposed updated clinical programme. This is 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 2/3 adaptive study which would encompass the same dose ranging, albeit within one continuous study. The chosen route will be agreed with the FDA. Further details on the study design and progress of the program will be communicated to the market once the FDA has been consulted and their response has been provided.
Potential Distribution Agreement
We have agreed to explore the opportunity of a mutually beneficial route to allow ImmuPharma to introduce certain Avion products into the European market. If this is successful, this would generate top-line product sales revenue for the first time in ImmuPharma's history and contribute net positive cash flow to the Company.
We in turn, have identified an established European partner who could provide the infrastruct