Biodexa says Phase 3 Serenta trial in FAP two-thirds enrolled, GIST trial prep advances

Biodexa Pharmaceuticals reported on November 9, 2026 that the company has enrolled 112 of an expected 168 participants in its registrational Phase 3 trial of eRapa, the company's reformulation of rapamycin, in familial adenomatous polyposis (NCT06950385).¹ The trial, branded "Serenta," is recruiting at 29 clinical sites across the US and five countries in Europe, with further sites in North America and Continental Europe expected to be initiated shortly.¹

The Serenta protocol provides for a pre-specified futility analysis after 25 progression free survival events and database lock after 75 PFS events.¹ Based on the current rate of PFS event accrual, the futility analysis could take place early in 2027 with database lock potentially occurring around the end of 2027, both significantly sooner than originally anticipated, the company said.¹

On the GIST program, Biodexa said it is planning a Phase 1a dose escalation study followed immediately by a Phase 1b dose optimization study to establish a maximum tolerated dose and, based on efficacy signals, an optimized dose for MTX240, with both phases recruiting patients who have demonstrated TKI-resistance.¹ The company said GMP drug substance has been manufactured by its CDMO partner, which is moving ahead with GMP finished product, and that a preferred CRO has been identified with Phase 1a expected to begin recruiting in South Korea mid-2027.¹ A pre-IND meeting with the FDA is scheduled for December 10, 2026.¹

CEO Stephen Stamp said database lock and topline data for the registrational FAP trial around the end of next year is now "tantalizingly close," and that around the same time the company should know whether it has a viable dose for MTX240 in TKI-resistant patients, which, if achieved, has the potential to alter standard of care for all GIST patients.¹