Biodexa announces approval of CTA by EMA of Phase 3 trial in FAP

Biodexa Pharmaceuticals (BDRX) announced the approval of a Clinical Trial Application, CTA, by the European Medicines Agency, EMA, of its Phase 3 Serenta trial in patients with familial adenomatous polyposis, FAP, a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. The only current treatment option is sequential resection of much of the gastrointestinal tract. Commenting, Dr Gary Shangold, Chief Medical Officer of Biodexa, said “Approval of our CTA by EMA is the latest in a series of important milestones for our eRapa Phase 3 program in FAP. We expect to accelerate recruitment by opening sites initially in four European countries. Thanks to the combined efforts of our team, our collaborators at Emtora Biosciences and our European CRO, Precision for Medicine”.