Revance Therapeutics Inc (RVNC)

[floblu14]

Revance to Showcase Phase 3 Results Evaluating DaxibotulinumtoxinA for Injection for the Treatment of Cervical Dystonia at the American Academy of Neurology Annual 2021 Virtual Meeting

NASHVILLE, Tenn.--(BUSINESS WIRE)--Apr. 1, 2021-- Revance Therapeutics (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the company will present an ePoster at the 2021 American Academy of Neurology (AAN) Virtual Annual Meeting taking place from April 17-22, 2021. Revance will present results from its ASPEN-1 Phase 3 clinical trial evaluating the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults.

“We’re pleased to present the efficacy and safety findings from the ASPEN-1 Phase 3 clinical trial evaluating DaxibotulinumtoxinA for Injection at this year’s 2021 AAN Virtual Meeting, specifically, the median duration of effect of up to 24 weeks, as determined by time to loss of 80% peak treatment benefit, suggested that DaxibotulinumtoxinA for Injection has the potential to reduce frequency of cervical dystonia treatments by up to 50% annually, while being generally safe and well tolerated,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “The findings being presented are part of a growing body of clinical evidence that supports DaxibotulinumtoxinA for Injection’s differentiated performance profile and underscores the potential of our therapeutics pipeline for the treatment of muscle movement and pain disorders for patients who suffer from these debilitating conditions.”

The abstracts are available online via the AAN website at www.aan.com.

ePoster Presentation:

Title: A Phase 3 Trial Evaluating the Efficacy, Duration of Effect, and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Cervical Dystonia
Authors and Affiliations: Joseph Jankovic, Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, TX; Cynthia Comella, Rush University Medical Center, Chicago, IL; Robert A. Hauser, Director of the University of South Florida Parkinson’s Disease and Movement Disorders Center, Tampa, FL; Atul T. Patel, Kansas City Bone & Joint Clinic, Overland Park, KS; Todd M. Gross, Roman G. Rubio, Domenico Vitarella, Revance Therapeutics, Newark, CA
ASPEN Phase 3 Clinical Program in Cervical Dystonia

In 2017, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for DaxibotulinumtoxinA for Injection to treat cervical dystonia, which provides certain developmental and financial benefits to trial sponsors.

The company’s ASPEN Phase 3 clinical program consists of two trials to evaluate the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults: 1) ASPEN-1, a randomized, double-blind, placebo-controlled, parallel group trial and 2) ASPEN-OLS, an open-label, long-term safety trial.

Randomized Trial (ASPEN-1): Patients were randomized to a single treatment of either 125 Unit or 250 Unit dose of DaxibotulinumtoxinA for Injection, or placebo. Post-treatment, patients are followed for a maximum of 36 weeks. The primary efficacy endpoint of the trial was the mean change from baseline in the TWSTRS Total Score at the average of Weeks 4 and 6. Key secondary endpoints include the duration of treatment effect, measurement of treatment response on the Clinical and Patient Global Impression of Change assessments, and adverse events. Further, the trial featured exploratory efficacy assessments including the Cervical Dystonia Impact Profile (CDIP-58), a disease-specific, patient-rated questionnaire that measures quality of life.

Open-Label Study (ASPEN-OLS): Patients receive up to four sequential treatment cycles of DaxibotulinumtoxinA for Injection over the 52-week observation period. Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with DaxibotulinumtoxinA for Injection. Key secondary endpoints are the change from baseline in TWSTRS Total Score and the duration of treatment effect, as well as overall treatment response based on the Clinical and Patient Global Impression of Change. The ASPEN-OLS trial is fully enrolled with a total of 354 patients at sites located in the United States, Canada, and Europe.

Additional information about the ASPEN Phase 3 program is available at www.clinicaltrials.gov.

https://investors.revance.com/news-releases/news-release-details/revance-showcase-phase-3-results-evaluating-daxibotulinumtoxina