Biodexa Pharmaceuticals announces outcome of a Type C meeting with FDA on eRapa

Biodexa Pharmaceuticals (BDRX) 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.