Biodexa Pharmaceuticals receives orphan drug designation in Europe for eRapa

Biodexa Pharmaceuticals (BDRX) announced the European Commission has granted Orphan Drug Designation for eRapa in familial adenomatous polyposis, a largely inherited precancerous disease of the colon for which there is currently no pharmaceutical intervention. “This Orphan Drug Designation is another important step as we move our FAP program forward into a registrational Phase 3 study.” said Stephen Stamp, CEO and CFO of Biodexa Pharmaceuticals PLC. “We are committed to providing global access to eRapa for as many patients as may benefit. This designation is an important step in our collaboration with EMA for our marketing authorization in the EU.” The Phase 3 study of eRapa in FAP is in the final stages of implementation. It will be a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo. It is expected the study will be conducted in approximately 30 clinical sites across the US and Europe. The US component of the study will be conducted by LumaBridge, based in San Antonio, Texas and the European component will be conducted by Precision for Medicine LLC. The Phase 3 study is supported by a $17M grant from the Cancer Prevention Research Institute of Texas and a company match of $8.5M which has already been paid, in full, into escrow.