Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP

Core Insights - Biodexa Pharmaceuticals announced a successful Type C meeting with the FDA regarding the Phase 3 program for eRapa in familial adenomatous polyposis (FAP) [1][2] - The Phase 3 study is substantially funded by a $17.0 million grant from CPRIT and an$8.5 million company match [1][3] 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 programs for type 1 diabetes and rare brain cancers [7][11] - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing rapamycin formulations [4][8] Phase 3 Study Details - The planned Phase 3 study will be a double-blind placebo-controlled trial involving 168 patients, randomized in a 2:1 ratio of drug to placebo, conducted across approximately 30 clinical sites in the US and Europe [3][4] - The US component will be managed by LumaBridge, while the European component will be conducted by Precision for Medicine LLC [3] Regulatory Pathway - The Type C meeting followed a productive End of Phase 2 meeting and discussions on the statistical plan, safety database, and composite endpoint for the Phase 3 study [2][4] - The agreement on the composite endpoint allows the company to finalize the protocol and begin patient recruitment in the US [4] Clinical Data - Phase 2 data showed eRapa to be safe and well-tolerated, with a median 17% reduction in total polyp burden at 12 months and a 75% non-progression rate overall [4][8] - In cohort 2, patients experienced an 89% non-progression rate and a 29% median reduction in polyp burden at 12 months [4]