Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) has recruited 87 of the 168 subjects required for its Phase 3 Serenta trial, marking the halfway point in enrollment for the registrational study evaluating eRapa in familial adenomatous polyposis (FAP).
The double-blind, placebo-controlled trial, registered as NCT06950385, is currently active at 29 clinical sites across the United States and five European countries, with three additional sites in Canada expected to commence recruitment shortly. Subjects are being randomized in a 2:1 ratio between the investigational drug and placebo.
The trial’s primary endpoint is Progression Free Survival (PFS), with a planned futility analysis after 25 PFS events and a final database lock following 75 events. The protocol incorporates a composite endpoint to define PFS events. Biodexa’s eRapa is a proprietary oral capsule formulation of rapamycin, an mTOR inhibitor previously granted Orphan Drug Designation in both the U.S. and Europe.
FAP, a rare genetic condition characterized by polyp proliferation in the colon and rectum, typically emerges in mid-adolescence. Incidence is estimated at 1 in 5,000 to 10,000 in the U.S. and 1 in 11,300 to 37,600 in Europe, with no approved therapeutic options currently available. Standard care relies on active surveillance and surgical resection.
The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas. Biodexa also maintains a pipeline including MTX240 for gastrointestinal stromal tumors and tolimidone for type 1 diabetes.
