ARTICLE | Clinical News

Santhera's idebenone misses in Phase I/II for primary progressive MS

March 9, 2018 7:09 PM UTC

Santhera Pharmaceuticals Holding AG (SIX:SANN) said idebenone (SNT-MC17) missed the primary endpoint in an NIH-sponsored Phase I/II trial to treat primary progressive multiple sclerosis (PPMS). In 66 evaluable patients, a once-daily 2,250 mg dose of the drug failed to significantly slow disease progression as measured by the CombiWISE rating scale during the 2-year treatment period compared with placebo.

Santhera said the study's small sample size was a "limitation" when studying a "complex, relentlessly progressing" disease. NIH's National Institute of Neurological Disorders and Stroke (NINDS) developed CombiWISE, a combinatorial weight-adjusted disability scale...