Biodexa hits 100-patient enrollment in Phase 3 FAP trial of eRapa

Biodexa Pharmaceuticals PLC announced on October 13, 2026 that it has enrolled 100 patients in its registrational Phase 3 trial of eRapa for Familial Adenomatous Polyposis (FAP), a study registered as NCT06950385. The company is developing eRapa for the treatment or prevention of gastrointestinal cancers, and this marks a milestone in the trial it calls "Serenta."¹

The trial is currently running across 29 clinical sites in the US and five European countries, with two additional sites in Canada expected to open soon.¹

Under the study design, a futility analysis is set to occur once 25 Progression Free Survival (PFS) events have accrued, with the database locking after 75 such events.¹ The protocol defines PFS events through a composite endpoint.¹

CEO Stephen Stamp said enrollment of the 100th patient reflects what he called strong recruitment performance at participating sites. He said that given the current pace of PFS event accrual, the futility analysis might occur in early 2027 and the database lock around the end of 2027, timelines he described as notably earlier than first expected.¹

There is currently no approved drug therapy for FAP, with patients relying on active surveillance and surgical removal of affected colon or rectal tissue.¹ Left untreated, FAP commonly progresses to colorectal cancer.¹ eRapa, an oral capsule formulation of rapamycin (sirolimus), holds Orphan Drug Designation in both the US and Europe.¹

Based on prior Phase 2 data, Biodexa launched this double-blind, placebo-controlled Phase 3 trial in the US and Europe, with plans to enroll 168 subjects in a 2:1 drug-to-placebo randomization.¹ The Phase 3 program is backed by a $20 million grant from the Cancer Prevention and Research Institute of Texas.¹