Biodexa Announces Enrolment of First European Patients into Pivotal Phase 3 Serenta Trial in FAP

Core Viewpoint - Biodexa Pharmaceuticals has initiated the enrollment of the first three patients in Europe for its pivotal Phase 3 Serenta trial of eRapa, 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 products for various conditions [2][9]. Trial Details - The Serenta trial (NCT06950385) is a double-blind, placebo-controlled study involving 168 patients, with a randomization ratio of 2:1 for drug versus placebo, aimed at evaluating the safety and efficacy of eRapa in FAP patients [4]. - The trial has identified all study sites and is onboarding additional European sites in the Netherlands, Spain, Denmark, and Italy, with nine more expected to activate in the next 2-3 months [4]. - The trial is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas [4]. Disease Context - Familial adenomatous polyposis (FAP) is a rare inherited disorder leading to the development of numerous colorectal polyps and a near-100% lifetime risk of colorectal cancer if untreated, with a prevalence of 1 in 5,000 to 10,000 in the US and 1 in 11,300 to 37,600 in Europe [5]. - Current treatment options for FAP are limited, primarily involving surgical resection, highlighting the need for effective and less invasive therapies [5]. Product Information - eRapa is an oral capsule formulation of rapamycin (sirolimus), an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing rapamycin formulations [6][10]. - The rationale for using eRapa in FAP treatment is supported by the over-expression of mTOR in FAP polyps, indicating its potential effectiveness [6]. Funding and Support - The Cancer Prevention and Research Institute of Texas has awarded $2.9 billion in grants to support cancer research, with a total investment of $6 billion approved by Texas voters for cancer research and prevention [7].