HD Insights™

Vol. 10 v.9 FINAL

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H D I N S I G H T S HD Insights, Vol. 10 2 Auspex, cont... Copyright © Huntington Study Group 2015. All rights reserved. H D I N S I G H T S Dr. Francis Walker, Professor of Neurology at Wake Forest University School of Medicine and unaffiliated with the study, told HD Insights, "SD-809 may have advantages over tetrabenazine in that it is taken twice instead of four times daily and seems to have a positive effect on function…by preliminary findings, [SD-809] seems to improve upon an existing treatment for HD related chorea." He cautioned, however, that, "Yet to be reported is the effect of SD-809 on cognition, an area where tetrabenazine has a mild negative effect." Dr. Frank highlighted several novel elements of the trial's design, saying, "This trial… [had] many novel aspects that we may be able [to] apply to other HD trials including capacity assessment in the context of a clinical trial, easy swallowing assessment and direct shipping of study drug to participants…[Additionally], we demonstrated that deuterated compounds penetrate the blood brain barrier, a concept that may be applied to other deuterated compounds used for other neurological conditions." Full results of First-HD are expected in 2015, and Arc-HD is scheduled to conclude in mid-2015. Auspex CEO Dr. Pratik Shah indicated that the company will submit a New Drug Application to the FDA by mid-2015 for SD-809 as a treatment for chorea in HD. Auspex continues to evaluate SD-809 in other conditions, including tardive dyskinesia and Tourette syndrome. Auspex announces positive topline results from registration trial of SD-809 for chorea associated with Huntington's disease. [Internet]. Auspex Pharmaceuticals; [updated 2014 Dec 31; cited Dec 31 2014]. Available from: investor.auspexpharma.com/releasedetail.cfm?releaseid=887958. The Huntington Study Group thanks the Fox Family Foundation for their support of HSG 2014 Table 1. SD-809 clinical trials in HD Trial Name Design Sample Size Primary Endpoint First-HD Randomized, double-blind, placebo controlled 12 week trial of SD-809 vs. placebo 90 Total maximal chorea score ARC-HD Open label, long-term safety study of SD-809 116 Overall incidence of adverse events ARC-HD Rollover First-HD participants who have completed First-HD and continue on SD-809 after 1 week washout 80 Overall incidence of adverse events ARC-HD Switch Four week trial to evaluate safety, tolerability and efficacy after switching patients from tetrabenazine to SD-809 at half the dose 36 Overall incidence of adverse events Source: clinicaltrials.gov

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