Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP

Core Insights - Biodexa Pharmaceuticals has activated its first European site for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP), marking a significant milestone in expanding treatment options for European patients [1][2] Company Overview - 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 therapies for type 1 diabetes and rare brain cancers [7] Clinical Trial Details - The Serenta trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy of eRapa in preventing disease progression in FAP patients, who face a near-100% risk of colorectal cancer by age 50 if untreated [3][4] - The trial began enrolling patients in the US in August 2025, with nine additional European sites expected to activate in the next 2-3 months across the Netherlands, Spain, Denmark, and Italy [3] Treatment Context - FAP is a rare inherited disorder characterized by the development of numerous colorectal polyps, leading to a significant unmet need for effective, less invasive therapies, as current standard care involves surgical resection [4] - eRapa, a proprietary oral formulation of rapamycin, is an mTOR inhibitor that targets the over-expression of mTOR in FAP polyps, providing a rationale for its use in treatment [5][8] Funding and Support - The advancement of the Serenta trial has been supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas, alongside collaborations with Emtora Biosciences and Precision for Medicine [2][6]