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Santhera’s study shows safety profile of idebenone at higher dose than now approved for Raxone in Leber’s hereditary optic neuropathy

Santhera CEO, Chief Executive Officer (CEO) of Santhera

An investigator-initiated trial at the National Institutes of Health (NIH) in an exploratory Phase I/II clinical trial in primary progressive multiple sclerosis (PPMS) has confirmed the safety profile of idebenone at a dose of 2,250 mg daily over a treatment period of two years. In assessing the efficacy of idebenone on disease progression, no difference between the active treatment group and placebo was observed, Santhera Pharmaceuticals said Monday.

The National Institute of Neurological Disorders and Stroke (NINDS), part of the US NIH, sponsored this investigator-initiated, double-blind, placebo-controlled Phase I/II trial (IPPoMS) investigating the safety and therapeutic efficacy of idebenone in PPMS.
The primary outcome to explore the efficacy of idebenone was the change in the CombiWISE.
Thomas Meier, CEO of Santhera, said that the long-term study in patients with PPMS confirms the favorable safety profile of idebenone given at higher dose than the currently approved dose for Raxone in Leber’s hereditary optic neuropathy. Meier said that the small sample size is a limitation when studying a therapeutic intervention in such a complex, relentlessly progressing neurological disease.
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