Santhera's FA drug misses endpoints in US Ph III trial

Swiss drugmaker Santhera says that its US Phase III trial evaluating Catena (idebenone) for Friedreich's Ataxia missed its primary endpoint  as measured by the International Cooperative Ataxia Rating Scale. The  study also did not show statistical significance on the second  neurological endpoint, the FA Rating Scale. While a consistent  improvement over baseline and placebo was seen, effect size was lower  than expected and patients on placebo improved unexpectedly, the firm  noted. Company chief executive  Klaus Schollmeier said: "the results  have not dampened our confidence in the drug's potential in Friedreich's  Ataxia. Because of its larger patient population and longer study  duration, we expect that the ongoing European Phase III MICONOS study  will finally provide the efficacy data necessary to support marketing  approval in the USA and Europe."