Biodexa Pharmaceuticals PLC Submits Clinical Trial Application for Phase 3 Serenta Trial in Familial Adenomatous Polyposis in Europe

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). If approved, the trial will proceed in Denmark, Germany, Netherlands, Spain, and Italy. The Serenta trial aims to evaluate the safety and efficacy of eRapa in FAP patients, with the first US site already open for enrollment. European sites are expected to begin enrolling in Q4 of this year.

Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) has taken a significant step forward in its quest to develop innovative treatments for rare diseases by filing a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Serenta trial in patients with familial adenomatous polyposis (FAP). If approved, the trial will proceed in Denmark, Germany, the Netherlands, Spain, and Italy.

The Serenta trial (NCT06950385) is designed as a randomized, double-blind, placebo-controlled Phase 3 study to evaluate the safety and efficacy of eRapa, a proprietary oral formulation of rapamycin, in FAP patients. The first site in the United States has already begun enrolling participants. The European sites are expected to commence enrollment in the fourth quarter of this year.

Biodexa's progress with the eRapa program, which includes FDA Fast Track Designation, European Orphan Drug designation, and initiation of the first US clinical site, underscores the company's commitment to addressing the significant unmet medical need for effective therapies in FAP. The program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

Biodexa's CTA filing with the EMA represents a significant regulatory milestone for the company, building on its previous achievements and expanding its international footprint. The trial aims to assess the potential of eRapa in treating FAP, a rare, inherited disorder characterized by the development of hundreds to thousands of colorectal polyps and a near-100% lifetime risk of colorectal cancer if left untreated.

For more information about the Serenta trial, including eligibility criteria and specific site locations, please visit [Serenta Trial Website](https://serentatrial.com/).

References:
[1] https://www.globenewswire.com/news-release/2025/07/14/3114750/0/en/Biodexa-Announces-Filing-of-CTA-in-Europe-for-Phase-3-Serenta-Trial-in-Familial-Adenomatous-Polyposis-FAP.html
[2] https://www.stocktitan.net/news/BDRX/biodexa-announces-filing-of-cta-in-europe-for-phase-3-serenta-trial-amhkmw7ntxy4.html