Enrollment completes in European idebenone trial

Santhera Pharmaceuticals, a Swiss specialty drugmaker focused on orphan neuromuscular diseases, says that recruitment has completed for its 12-month European Phase III trial evaluating SNT-MC17/idebenone in Friedreich's Ataxia, a severe and degenerative neuromuscular disorder.

The 13 study centers in six European countries have enrolled a total of 232 adult patients. The completion of recruitment in Europe follows shortly after Santhera announced a similar milestone for its six-month pivotal Phase III trial in the USA in the same indication. SNT-MC17/idebenone is approved by Health Canada for the treatment of FA and is available under the brand name Catena.

The European Phase III MICONOS trial is a double-blind, randomized, placebo-controlled study investigating the efficacy of three doses of SNT-MC17/idebenone compared to placebo. The primary endpoint is the change in the International Cooperative Ataxia Rating Scale, a neurological scale where the difference between baseline and end of treatment for each of the dosing groups will be compared with the change in the placebo group.