IMMUPHARMA PLC 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, as previously notified *.
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 infrastructure to market and distribute the products.
Discussions are to be progressed as to the legal, regulatory and commercial aspects of such a collaboration and we will provide further details in due course.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:
"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. 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."
Responding, Art Deas, CEO of Avion, said:
"We continue to be very supportive of Lupuzor™ and to work with ImmuPharma to find the optimum way forward for Lupuzor™ in its clinical program. As a supportive and involved partner with ImmuPharma, we will continue to look at new initiatives to create value by working effectively and diligently with the team at ImmuPharma."
This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation no 596/2014 which is part of English law by virtue of the European (withdrawal) Act 2018, as amended. On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.
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Immupharma plc published this content on 18 November 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 November 2022 12:18:01 UTC.
