Biodexa Announces Award of Additional $3.0M Grant from CPRIT to Support Registrational eRapa Phase 3 Program in FAP Brings Total CPRIT Grant Funding for eRapa Phase 3 Program to $20.0M

Core Viewpoint - Biodexa Pharmaceuticals has received an additional $3.0 million grant from CPRIT, bringing the total funding for the eRapa Phase 3 program to $20.0 million, aimed at treating familial adenomatous polyposis (FAP) [1][2]. Group 1: Grant and Funding - The additional grant from CPRIT will facilitate the inclusion of more clinical sites and accelerate patient recruitment for the eRapa Phase 3 program [2]. - CPRIT has awarded a total of $2.9 billion in grants to Texas research institutions, supporting various research programs and generating over $5.7 billion in additional investments [2]. Group 2: eRapa Phase 3 Program - The Phase 3 study of eRapa in FAP will involve 168 patients in a double-blind placebo-controlled trial, with a 2:1 randomization of drug to placebo [3]. - The study is expected to be conducted across approximately 30 clinical sites in the US and Europe, with recruitment anticipated to begin in the coming weeks [3]. Group 3: Familial Adenomatous Polyposis (FAP) - FAP is characterized by the proliferation of polyps in the colon and/or rectum, typically starting in mid-teens, with no approved therapeutic options currently available [4]. - The prevalence of FAP is reported to be between 1 in 5,000 to 10,000 in the US and 1 in 11,300 to 37,600 in Europe, indicating a significant hereditary component [4]. Group 4: Market Opportunity - The combined addressable market for eRapa in FAP is estimated at approximately $7.3 billion, based on the lowest prevalence estimates and the adult populations in the US and Europe [5]. Group 5: About eRapa - eRapa is an oral tablet formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [6][7]. - Data from the Phase 2 study indicated eRapa was safe and well-tolerated, showing a median 17% reduction in total polyp burden at 12 months compared to baseline [7].