Biodexa hopes to help with eRapa, a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. "Too much mTOR has ...

The company recently received Fast Track designation from the FDA for eRapa, held a productive Type C meeting to finalize the Phase 3 protocol, and appointed clinical research organizations (CROs ...

Biodexa Pharmaceuticals (BDRX) is making progress in readying the launch of a phase 3 trial for eRapa, its proprietary encapsulated form of rapamycin being developed for the treatment of familial ...

"With no approved products for FAP, we were pleased to collaborate with FDA and our US CRO, LumaBridge, to define the regulatory pathway for eRapa in FAP. Agreement on the composite endpoint ...

Biodexa Pharmaceuticals announced a successful Type C meeting with the FDA, which has cleared the way to finalize the Phase 3 protocol for its drug eRapa in treating familial adenomatous polyposis ...

Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP Clears the way to finalize Phase 3 protocol and recruit sites for U.S. Phase 3 ...

The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data at ...

The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data ...

The planned registrational Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted ...