Core Viewpoint - Biodexa Pharmaceuticals is advancing its clinical development of eRapa for Familial Adenomatous Polyposis (FAP) by appointing Precision for Medicine as the CRO for the European component of a Phase 3 study, which is set to begin next quarter [1][2]. Group 1: Study Details - The Phase 3 study of eRapa will be a double-blind placebo-controlled trial involving 168 patients, with a randomization ratio of 2:1 for drug versus placebo [2]. - The study is expected to take place at approximately 30 clinical sites across the US and Europe [2]. Group 2: Company Background - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs, including eRapa for FAP and other conditions [5]. - The company is headquartered in Cardiff, UK, and is listed on NASDAQ under the ticker BDRX [5][9]. Group 3: eRapa Overview - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, which plays a significant role in regulating cellular metabolism and is over-expressed in FAP polyps [4][6]. - The formulation aims to improve bioavailability and reduce toxicity associated with existing rapamycin products [4]. Group 4: Precision for Medicine - Precision for Medicine, appointed as the CRO, specializes in rare diseases and has conducted 333 clinical trials, employing over 700 staff across 11 locations in Europe [3].
Biodexa Announces Appointment of Precision for Medicine LLC as CRO for European Component of Phase 3 Study of eRapa in FAP