Santhera's US Ph III FA drug trial completes recruitment

The USA's Santhera Pharmaceuticals has completed recruitment for its six-month pivotal Phase III trial with SNT-MC17 (idebenone) in Friedreich's Ataxia in the USA. The two study centers have enrolled a total of 70 patients. Strong support from patient advocacy groups helped the trial exceed the original recruitment target of 51 individuals, the firm said.

The IONIA trial is a double-blind, randomized, placebo-controlled study of six month's duration investigating the efficacy of two 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 featuring endpoints on activities of daily living and cardiac outcomes.