newsfilter
← Latest News
GlobeNewswire·

Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress

BDRX
  • Biodexa Pharmaceuticals PLC received approval from Health Canada to expand its Serenta Phase 3 registrational trial for Familial Adenomatous Polyposis (FAP) into Canada.
  • The trial is currently active across 29 centers in the US & five European countries, with 3 to 4 additional centers expected in Canada.
  • The Serenta study aims to enroll 168 patients, of which 73 have been enrolled as of June 29, 2026.
  • CEO Stephen Stamp noted accelerated enrollment due to recent European center openings & confirmed Canada will support enrollment goals for this life-altering condition with no approved therapies.
  • FAP involves colon polyp proliferation typically appearing in mid-teens, often leading to cancer if untreated, with a hereditary incidence of 1 in 5,000 to 10,000 in the US.
  • eRapa, a proprietary oral capsule of rapamycin (sirolimus), acts as an mTOR inhibitor shown to be over-expressed in FAP polyps, providing the scientific rationale for its use.
  • The Phase 3 program is double-blind & placebo-controlled with a 2:1 drug-to-placebo randomization, supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
  • eRapa holds Orphan Drug Designation in the US, with plans to seek similar status in Europe.
  • Biodexa's other development programs include MTX240 for Gastrointestinal Stromal Tumors (GIST) & tolimidone for type 1 diabetes.
  • Biodexa is headquartered in Cardiff, UK, with R&D operations there.