(RTTNews) - Biodexa Pharmaceuticals PLC (BDRX), a clinical-stage biopharmaceutical company, Thursday announced that its collaboration partner, Emtora Biosciences, has been awarded an additional $3.0 million grant from the Cancer Prevention & Research Institute of Texas or CPRIT to support the registrational Phase 3 trial of eRapa for familial adenomatous polyposis or FAP.
This award increases total CPRIT funding for the eRapa program to $20.0 million, accelerating efforts to bring the investigational therapy to FAP patients who currently face surgical removal of the colon or rectum as the only option.
The upcoming Phase 3 trial will evaluate eRapa, a proprietary oral formulation of rapamycin and mTOR inhibitor, in 168 FAP patients across approximately 30 clinical sites in the US and Europe.
The trial will follow a randomized, double-blind, placebo-controlled design and is expected to begin recruiting participants in the coming weeks.
Data from an earlier Phase 2 study showed eRapa to be safe and well-tolerated, with meaningful reductions in polyp burden and high non-progression rates in FAP patients.
FAP is a rare genetic disorder affecting up to 1 in 10,000 individuals in the U.S. It is characterized by the growth of numerous polyps in the colon and rectum, which, if untreated, can lead to colorectal cancer.
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