Biodexa Pharmaceuticals (NASDAQ:BDRX) has announced that eRapa, a form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP), has been granted Fast Track Designation by the FDA.
According to Biodexa, the designation was requested based on eRapa’s potential to address an unmet medical need for FAP, a condition that, if left untreated, universally progresses to colorectal cancer. Currently, the only treatment for FAP is surgical resection of the colon or rectum.
The company further reports that data from the Phase 2 study of eRapa in FAP demonstrated that eRapa is safe and well-tolerated, with a median 17% reduction in total polyp burden at 12 months compared to baseline and an overall 75% non-progression rate. Patients in Cohort 2 achieved an 89% non-progression rate and a 29% median reduction in polyp burden at 12 months compared to baseline. The dosing regimen used in Cohort 2—daily every other week—has been selected as the preferred dosage for the upcoming registrational Phase 3 study.
