Biodexa Announces Activation of First Clinical Study Site for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)

Core Viewpoint - Biodexa Pharmaceuticals has activated the first clinical study site for its Phase 3 Serenta trial targeting familial adenomatous polyposis (FAP), marking a significant milestone in developing a new treatment option for this condition [1][3]. Group 1: Clinical Trial Details - The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of eRapa in individuals diagnosed with FAP [2]. - The first clinical site in the US is now open and actively screening eligible participants for the trial [2]. Group 2: Company Achievements and Support - Biodexa's CEO, Stephen Stamp, highlighted the importance of the first clinical site activation following the Fast Track Designation and a positive Type C Meeting, emphasizing the collaborative efforts with Emtora Biosciences and LumaBridge [3]. - The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $20 million in grant funding to support the eRapa program, showcasing significant financial backing for the initiative [3][6]. Group 3: Background on Familial Adenomatous Polyposis (FAP) - FAP is a rare inherited disorder characterized by the development of hundreds to thousands of colorectal polyps, with a near-100% lifetime risk of colorectal cancer if untreated [4]. - There is a significant unmet need for effective and less invasive therapies for FAP patients, as current standard care involves active surveillance and surgical resection [4]. Group 4: About eRapa - eRapa is a proprietary oral formulation of rapamycin (sirolimus), an mTOR inhibitor, which plays a crucial role in regulating cellular metabolism, growth, and proliferation [5][8]. - The formulation is designed to improve bioavailability and reduce toxicity associated with existing rapamycin forms, with patent protection extending through 2035 [5][11].