Biodexa Announces Outcome Of Type C Meeting With FDA Regarding The Phase 3 Program For eRapa In FAP; Clears The Way To Finalize Phase 3 Protocol And Recruit Sites For U.S.

Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP

Clears the way to finalize Phase 3 protocol and recruit sites for U.S.

Phase 3 substantially funded by $17.0 million CPRIT grant and $8.5 million Company match

Biodexa Pharmaceuticals PLC ("Biodexa" or the "Company") (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the results of its Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding the protocol for the planned registrational Phase 3 study of eRapa in familial adenomatous polyposis ("FAP").

The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data at InSight, Barcelona in June 2024. The Type C meeting included a discussion of the statistical plan, the safety database and, most importantly, a composite endpoint for the Phase 3 study. FDA representatives from both Gastroenterology and Oncology Divisions provided valuable input into the proposed program and the Company believes there is a clear path forward for initiation of the registrational Phase 3 study in FAP in the U.S. next quarter.

The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted in approximately 30 clinical sites across the US and Europe. The US component of the study will be conducted by LumaBridge, based in San Antonio, Texas and the European component will be conducted by Precision for Medicine LLC. The Phase 3 study is supported by a $17.0 million grant from the Cancer Prevention Research Institute of Texas ("CPRIT") and a Company match of $8.5 million which has already been paid, in full, into escrow.