Auspex Announces Results From Thorough QT Clinical Trial Of SD-809

(RTTNews) - Auspex Pharmaceuticals Inc. (ASPX) announced favorable topline safety results from its thorough QT or TQT clinical trial evaluating the effects of SD-809 on cardiac repolarization, based on placebo-corrected, time-matched changes from baseline in the corrected QT or QTc interval.

The TQT clinical trial demonstrated that at two different dose levels, SD-809 had no clinically significant effect on cardiac repolarization as assessed by the QT interval.

A tetrabenazine arm was included for comparison and demonstrated an increase in QTc that is consistent with the effect reported in the FDA label for Xenazine. The clinical trial's assay sensitivity was established by the observation of characteristic QTc prolongation following dosing with moxifloxacin.

In December 2014, Auspex reported positive topline results from a Phase 3 clinical trial evaluating SD-809 in chorea associated with Huntington's disease, demonstrating robust efficacy, supported by significant improvements in patient global impression of change, clinical global impression of change and quality of life as well as a favorable safety and tolerability profile.

Based on these positive SD-809 data, Auspex provided one-time guidance regarding its planned spending in 2015. Auspex intends to incur $85 million -$90 million in research and development (R&D) expense and $25 million -$30 million in general and administrative (G&A) expense in 2015. These two ranges include $14 million of non-cash stock-based compensation expense.