Success for SD 809 in Phase III trial for Chorea associated with Huntington's disease- Auspex
Auspex Pharmaceuticals, Inc. announced positive topline efficacy and safety results from its Phase III - First-HD.-registration trial evaluating SD-809 for the treatment of Chorea associated with Huntington's disease (HD).In addition to meeting the primary efficacy endpoint, significant improvements in both patient and clinical global impressions of change and quality of life were observed. Importantly, the study showed a favourable safety and tolerability profile, including low rates of depression, somnolence, akathisia/restlessness and anxiety.
In addition, Auspex announced results from an analysis of the completed four-week Switch portion of the ARC-HD study, which also has an ongoing long-term safety component. Data from the study show that patients who switched from the current standard of care, tetrabenazine, to SD-809 maintained Chorea control at both week one and week four.
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