eRapa (rapamycin, sirolimus) - (Serenta)

August 19, 2026: Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) said its registrational Phase 3 Serenta trial of eRapa in Familial Adenomatous Polyposis (FAP; NCT06950385) has passed the halfway enrollment mark, with 87 of 168 planned subjects recruited.

Serenta is a double-blind, placebo-controlled study recruiting at 29 sites across the US and five European countries; three additional Canadian sites are expected to open shortly. The trial plans a futility analysis after 25 progression-free survival (PFS) events and database lock after 75 PFS events; the protocol uses a composite endpoint to define PFS events.

The company said eRapa has Orphan Drug Designation in the US and Europe. It also noted that open-label Phase 2 data were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, and that those data supported initiation of the Phase 3 program. The Phase 3 program is backed by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

The release also lists other pipeline programs: eRapa in non-muscle invasive bladder cancer, MTX240 in GIST, and tolimidone in type 1 diabetes.