Core Insights - Biodexa Pharmaceuticals PLC announced promising results from a Phase 2 clinical trial of eRapa™ for Familial Adenomatous Polyposis (FAP), showing a 75% non-progression rate at 12 months and a median reduction in polyp burden of 17% [1][4][5] Group 1: Clinical Trial Results - The Phase 2 study reported that 21 out of 28 patients (75%) were non-progressors at 12 months, with a median reduction in polyp burden of 17% [4][5] - In Cohort 2, 89% of patients were non-progressors with a median reduction in polyp burden of 29% [5][12] - The study was partially funded by a $3 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) [2] Group 2: Future Studies and Funding - A Phase 3 registrational study is planned, which will be a double-blind placebo-controlled trial involving approximately 140 high-risk patients [6] - The Phase 3 study is supported by a $17 million grant from CPRIT [2][6] - The primary endpoint for the Phase 3 study will focus on the first progression-free survival event, including major surgery and diagnosis of high-grade dysplasia or cancer [6] Group 3: Drug Information - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [7][19] - eRapa has received Orphan Designation in the US, with plans to seek similar designation in Europe [15] Group 4: 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 products for different indications [23][25]
Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP)