GlobeNewswire·Nov 9, 2026, 8:30 AM ET

Biodexa provides R&D Update

Biodexa Pharmaceuticals has recruited 112 of 168 expected participants in the Phase 3 Serenta trial for eRapa in familial adenomatous polyposis (FAP).
The Serenta trial is recruiting at 29 clinical sites across the US & five European countries, with additional sites in North America & Continental Europe expected soon.
Based on current accrual rates, the futility analysis for the Serenta trial could occur early in 2027, with a database lock potentially around the end of 2027.
Biodexa is advancing preparations for a Phase 1a dose escalation & Phase 1b dose optimization study of MTX240 in tyrosine kinase inhibitor (TKI)-resistant gastrointestinal stromal tumors (GIST).
GMP drug substance & finished product for MTX240 are being manufactured by a CDMO partner, & a preferred contract research organization (CRO) has been identified.
The Phase 1a trial for MTX240 is expected to begin recruiting in South Korea mid-2027.
A pre-IND meeting with the FDA for MTX240 is scheduled for December 10, 2026.
CEO Stephen Stamp stated that top-line data for the FAP trial is expected around the end of next year, with MTX240 viability data anticipated around the same time.
Biodexa also develops tolimidone for type 1 diabetes, which acts as a selective activator of Lyn kinase to modulate blood glucose.

Company: Biodexa Pharmaceuticals PLC
Keywords: Nasdaq:BDRX, Biodexa Pharmaceuticals PLC, BDRX, Serenta, Phase 3, Familial Adenomatous Polyposis, FAP, GIST, MTX240, eRapa