Clinical TrialJun 29, 2026, 08:32 AM
Biodexa gets Health Canada nod to expand Serenta Phase 3 trial
AI Summary
Biodexa Pharmaceuticals Plc received approval from Health Canada to expand its registrational Phase 3 trial for Serenta in Familial Adenomatous Polyposis (FAP) into Canada. The Serenta trial is already active in 29 centers across the US and Europe, with Canada expected to add 3-4 new centers. Currently, 73 out of 168 target patients have been enrolled, with an acceleration in enrollment recently. Serenta, an eRapa formulation, targets FAP, a condition with no approved therapeutic options, and has Orphan Designation in the US.
Key Highlights
- Health Canada approved expansion of Serenta Phase 3 trial for FAP.
- Trial to add 3-4 new clinical centers in Canada.
- Currently 29 active recruiting centers in the US and Europe.
- 73 patients enrolled out of a target of 168 for the Serenta trial.
- Enrollment has accelerated in recent months.
- Serenta (eRapa) has Orphan Designation in the US for FAP.
- Phase 3 program is supported by a $20 million grant from CPRIT.
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