Santhera Announces Start of US Phase III Clinical Trial with SNT-MC17 in Friedreich’s Ataxia and Provides Details on Study Design
Initiation of a six month study with 51 FRDA patients and ICARS as primary endpoint expected shortly. Fast-track designation granted by FDA.
Liestal, Switzerland, September 28, 2007 – Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical company focused on neuromuscular diseases, announced today that it has reached an agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure relating to the Phase III clinical trial to evaluate SNT-MC17 (INN: idebenone) for the treatment of Friedreich’s Ataxia (FRDA). The protocol incorporates advice provided by the FDA on the design of the study, its endpoints, statistical analysis and conduct. The FDA granted a fast track designation to Santhera’s compound in FRDA.