Biodexa Announces Approval of CTA in Europe for Phase 3 Serenta Trial in FAP First European patient expected to be enrolled in 4Q 2025 Addressable US - European Market Put at $7 Billion

Core Viewpoint - Biodexa Pharmaceuticals has received approval from the European Medicines Agency (EMA) for a Clinical Trial Application (CTA) to initiate the Phase 3 Serenta trial for eRapa in patients with familial adenomatous polyposis (FAP), targeting a significant unmet medical need in a $7 billion market [2][5]. 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 programs for type 1 diabetes and rare brain cancers [10][14]. Clinical Trial Details - The Serenta trial is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of eRapa in FAP patients, with an expected enrollment of 168 patients in a 2:1 drug to placebo ratio [5]. - The trial will initially take place in Denmark, Germany, the Netherlands, and Spain, with Italy expected to be added later [3][4]. Market Potential - The addressable market for FAP treatment is estimated at $7 billion, highlighting the significant opportunity for Biodexa to be a first mover in this space [5]. Disease Background - Familial adenomatous polyposis (FAP) is a rare inherited disorder that leads to a near-100% lifetime risk of colorectal cancer if untreated, with no approved therapeutic options currently available [7]. - The prevalence of FAP is reported to be between 1 in 5,000 to 10,000 in the US and 1 in 11,300 to 37,600 in Europe, indicating a significant need for effective treatments [7]. Product Information - eRapa is an oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [8][11].