Biodexa Expands Serenta Phase 3 Trial into Canada — Biodexa Pharmaceuticals PLC

Event summary

Biodexa Pharmaceuticals received approval from Health Canada to expand its Serenta Phase 3 trial for Familial Adenomatous Polyposis (FAP) into Canada.
The trial, already running in 29 centers across the US and Europe, will add 3-4 new centers in Canada.
As of June 29, 2026, 73 out of 168 planned patients have been enrolled in the study.

The big picture

Biodexa's expansion into Canada underscores its strategy to broaden the Serenta trial's geographic reach, potentially expediting regulatory approval for eRapa. The move comes amid a competitive landscape where FAP patients lack approved therapeutic options, positioning Biodexa as a key player in addressing this unmet need. With CPRIT's $20 million grant backing the Phase 3 program, the company is well-funded to pursue its clinical and commercial objectives.

What we're watching

Trial Momentum: Whether the addition of Canadian sites will accelerate patient enrollment and meet Biodexa's registration goals.
Regulatory Strategy: How Health Canada's approval may influence similar expansions in other regions or future trial designs.
Competitive Positioning: The pace at which Biodexa can differentiate eRapa in the FAP market, where surgical resection remains the standard of care.