Biodexa Pharmaceuticals PLC(US:BDRX) GlobeNewswire News Room·2025-07-14 12:30Core Viewpoint - Biodexa Pharmaceuticals has filed a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Phase 3 Serenta trial targeting familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer if untreated [2][4]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other conditions [2][11]. - The company has received Fast Track Designation from the FDA and Orphan Drug designation in Europe for its eRapa program [4]. Clinical Trial Details - The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled Phase 3 study aimed at evaluating the safety and efficacy of eRapa in FAP patients [5]. - The trial will initially cover clinical sites in Denmark, Germany, Netherlands, and Spain, with Italy expected to be added later [3]. Funding and Support - The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $20 million in grant funding to support the eRapa program [4]. - CPRIT has a history of significant investment in cancer research, having awarded $2.9 billion in grants to date [9]. Disease Context - Familial adenomatous polyposis (FAP) is characterized by the development of hundreds to thousands of colorectal polyps, leading to a near-100% lifetime risk of colorectal cancer if untreated [7]. - There is a significant unmet need for effective therapies for FAP, as current treatment options primarily involve surgical resection [7]. Product Information - eRapa is a proprietary oral formulation of rapamycin (sirolimus), an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing formulations [8][12]. - The product is protected by multiple patents extending through 2035, with additional applications pending [8].