Biodexa Pharmaceuticals Enrolls 100 Patients In Its Registrational Phase 3 Serenta Trial Of eRapa In Familial Adenomatous Polyposis; Trial Is Recruiting At 29 Clinical Sites In U.S., Canada And Europe And Is Expected To Be Initiated Shortly

Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) ("Biodexa" or "the Company"), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has enrolled 100 patients in its registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis (FAP), NCT06950385. The trial, branded "Serenta" is recruiting at 29 clinical sites across the US and five countries in Europe with a further two sites in Canada expected to be initiated shortly.

The Serenta protocol provides for a pre-specified futility analysis after 25 Progression Free Survival (PFS) events and database lock after 75 PFS events in the Serenta trial. The Serenta protocol includes a composite endpoint which defines the nature of the PFS events.