Biodexa Pharma Files CTA With EMA For Serenta Trial In Patients With Familial Adenomatous Polyposis

Biodexa Announces Filing of CTA in Europe for Phase 3 Serenta Trial in

Familial Adenomatous Polyposis (FAP)

Biodexa Pharmaceuticals PLC ("Biodexa" or "the Company"), (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced the filing of a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Serenta trial in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. The only current treatment option is sequential resection of much of the gastrointestinal tract.

A CTA is the formal regulatory submission required to obtain approval to begin a clinical trial in Europe and is similar to the Investigational New Drug (IND) application process in the United States. if approved, it would permit the Serenta trial to proceed in Europe, initially covering clinical sites in Denmark, Germany, Netherlands and Spain with Italy expected to be added in due course.

The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled Phase 3 registrational study designed to evaluate the safety and efficacy of eRapa in patients diagnosed with FAP. The first site, in the US, is now open and actively screening eligible participants. Following the 106 day approval timeline for the CTA, it is expected the European sites will begin enrolling in the fourth quarter of this year.