Biodexa Announces Enrolment of First Patients into Pivotal Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)

Core Insights - Biodexa Pharmaceuticals has enrolled the first two patients in its pivotal Phase 3 Serenta trial for eRapa, targeting familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer [2][3] - The company aims to be the first mover in a $7.3 billion addressable market for FAP treatments, with eRapa being the only drug candidate currently in Phase 3 trials [3][8] Company Overview - Biodexa Pharmaceuticals 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 different conditions [2][10] - The company has received $20 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Serenta trial [3][9] Trial Details - The Serenta trial is a double-blind, placebo-controlled study involving 168 patients, with a randomization ratio of 2:1 for drug versus placebo [5] - The trial will be conducted across multiple sites, including 20 in the US and 10 in Europe, managed by LumaBridge and Precision for Medicine, respectively [5] Disease Context - Familial adenomatous polyposis (FAP) is characterized by the development of numerous colorectal polyps and a near-100% lifetime risk of colorectal cancer if untreated, highlighting the urgent need for effective therapies [6] - Current treatment options are limited to surgical interventions, underscoring the significance of developing non-surgical alternatives like eRapa [4][6] Market Opportunity - The estimated addressable market for eRapa in FAP is approximately $7.3 billion, based on prevalence rates and the median annual cost of approved non-biologic orphan drugs [8]