Auspex Pharmaceuticals announced today that the first patient has been enrolled in a multi-center Phase 3 pivotal trial of its lead investigational drug, SD-809 for the treatment of involuntary movements (chorea) associated with Huntington's Disease (HD). Top-line data from the trial, designated the First-HD study, are expected in 2014.
"SD-809 is a deuterated form of tetrabenazine with pharmacokinetic properties that allow for more c
.onsistent blood levels and less frequent dosing. This may lead to improved medication compliance and patient outcomes," said David A. Stamler, MD, Auspex Chief Medical Officer. "We are enthusiastic to be conducting this study in partnership with the Huntington Study Group, an international network of experienced clinical trial investigators at leading academic centers that care for HD patients and families."
First-HD, or "First time use of SD-809 in HD", is a randomized, double-blind, placebo-controlled study that will test the efficacy, safety and tolerability of SD-809 in the management of chorea symptoms in 90 HD patients who have not previously taken tetrabenazine. The primary endpoint for the study will be Total Maximal Chorea (TMC) score. Secondary endpoints will include treatment success measurements based on patient and clinical global impressions of change. Participants will be involved in this trial for approximately four months. In parallel with First-HD, Auspex will be conducting an open-label study of SD‑809 in experienced tetrabenazine users and subjects who complete First-HD (Alternatives for Reducing Chorea in HD or ARC-HD Trial).