Biodexa Pharmaceuticals PLC(US:BDRX) Newsfilter·2024-05-21 12:30Core Insights - Biodexa Pharmaceuticals PLC announced positive Phase 2 clinical trial results for eRapa™ in treating Familial Adenomatous Polyposis (FAP), with an overall 83% non-progression rate at six months and a statistically significant 24% reduction in polyp burden (p=0.04) [2][6][7] 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 treatments for type 1 diabetes and rare brain cancers [12][13] Clinical Trial Details - The Phase 2 study was an open-label trial conducted across seven U.S. centers, involving 30 adult patients with a median age of 43 years, assessing safety, tolerability, and polyp burden changes over a 12-month treatment period [4][5] - Patients were divided into three dosing cohorts, with the primary endpoints being safety and percentage change in polyp burden at six months [5] Results Summary - At six months, 78% of patients in the duodenum and 86% in the colorectum were classified as non-progressors, with a significant number showing partial response [6][7] - Only two drug-related Grade 3 Serious Adverse Events were reported, and 97% of patients remained on treatment at the six-month mark [6][7] About eRapa - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing rapamycin formulations [8][14] - The drug has received Orphan Designation in the U.S. and plans to seek similar designation in Europe, targeting a significant unmet need in FAP treatment [9] Funding and Support - The study received partial funding of $20 million from the Cancer Prevention and Research Institute of Texas, which has invested significantly in cancer research and prevention initiatives [3][10]