Biodexa Secures FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis

Biodexa Pharmaceuticals PLC, a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced that the US Food and Drug Administration (“FDA”) has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

The designation was requested based on the potential for eRapa to address an unmet medical need for FAP, a condition which left untreated universally leads to colorectal cancer. Today, the only treatment option is surgical resection of the colon and/or rectum. Data from the Phase 2 study of eRapa in FAP showed eRapa to be safe and well-tolerated with a median 17% reduction in total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. Patients in cohort 2 experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The dosing given to cohort 2 – daily every other week — is the preferred dosage regimen for the upcoming registrational Phase 3 study.