Biodexa files CTA for Serenta trial in familial adenomatous polyposis.

Biodexa Pharmaceuticals has filed a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Serenta trial in patients with familial adenomatous polyposis (FAP), a genetic disorder leading to colorectal cancer if left untreated. The trial aims to evaluate the efficacy and safety of Serenta in treating FAP. If approved, it would permit the trial to proceed in Europe. The filing is similar to the IND application process in the US.

Biodexa Pharmaceuticals PLC ("Biodexa") has filed a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Serenta trial, targeting Familial Adenomatous Polyposis (FAP), a genetic disorder that, if left untreated, almost invariably leads to colorectal cancer. The CTA filing is a significant milestone for Biodexa, following previous regulatory achievements such as FDA Fast Track Designation and European Orphan Drug designation. The Serenta trial aims to evaluate the efficacy and safety of eRapa, a proprietary oral formulation of rapamycin, in treating FAP patients.

The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the safety and efficacy of eRapa in FAP patients. If approved, the trial will initially cover clinical sites in Denmark, Germany, the Netherlands, and Spain, with Italy expected to be added later. The first site in the US is already open and actively screening participants.

The filing of the CTA represents a major step forward in Biodexa's eRapa program, which is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). This funding underscores the significant external validation of the program and its potential to address the substantial unmet medical need in FAP patients.

FAP is characterized by the development of hundreds to thousands of colorectal polyps and a near-100% lifetime risk of colorectal cancer if left untreated. Currently, the standard of care for FAP patients is active surveillance and surgical resection of the colon and/or rectum. The approval of eRapa as a non-surgical intervention for this rare inherited condition could significantly improve patient outcomes and reduce the burden of disease.

Biodexa's CTA filing positions the company to expand its international clinical footprint beyond its already initiated US site, which is actively screening participants. If approved following the standard 106-day review timeline, European enrollment could begin in the fourth quarter of 2025.

References:
[1] https://uk.finance.yahoo.com/news/biodexa-announces-filing-cta-europe-123000302.html
[2] https://www.stocktitan.net/news/BDRX/biodexa-announces-filing-of-cta-in-europe-for-phase-3-serenta-trial-amhkmw7ntxy4.html