Revance reports positive results from ASPEN-1 phase III trial of daxibotulinumtoxinA for injection in cervical dystonia.

Revance Therapeutics, Inc. , announced positive topline results from its ASPEN-1 Phase III randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia , a chronic and debilitating neurologic condition affecting the muscles of the neck. This pivotal study enrolled a total of 301 subjects at 60 sites in the U.S., Canada and Europe. Subjects were randomized 3:3:1 to receive a single treatment of either 125 Units or 250 Units of DaxibotulinumtoxinA for Injection, or placebo and were followed for up to 36 weeks. The drug was generally safe and well-tolerated at both doses, with an encouraging safety profile. The study met its primary efficacy endpoint at both doses, demonstrating a clinically meaningful improvement in the signs and symptoms of cervical dystonia at the average of Weeks 4 and 6. Compared to placebo, subjects treated with either 125 Units or 250 Units showed a statistically significant greater change from baseline (12.7 and 10.9 respectively vs. 4.3, p<0.0001 and p="0.0006)" as measured on the toronto western spasmodic torticollis rating scale (twstrs) total score. median duration of effect was 24.0 and 20.3 weeks, for the 125 unit and 250 unit dose groups respectively, based on the median time to loss of 80% of the peak treatment effect. the median duration of effect was 24.0 weeks for the 125 unit dose, and 20.3 weeks for the 250 unit dose, as measured by the time to loss of 80% of the peak treatment effect. two of the secondary endpoints measured the percentage of responders showing improvement with at least a 2-point improvement based on the clinical global impression of change (cgic) and patient global impression of change (pgic) at week 4 or 6. both the clinician and patient results were consistent and showed a statistically significant improvement greater than placebo (p><0.001).. the company expects results from the companion aspen-ols phase iii open-label, long-term safety trial, which enrolled 354 subjects, in 2021.>