Revance Announces Positive Topline Phase 2 Data Supporting Advancement of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity - Seite 2

On a key secondary endpoint, DaxibotulinumtoxinA for Injection delivered a median duration of at least 24 weeks across all three doses. Duration of effect was defined as the time from injection (in weeks) until the loss of improvement as measured by the MAS (for the suprahypertonic muscle group or SMG) and the PGIC, or a request for retreatment by the subject.

All three doses of DaxibotulinumtoxinA for Injection were generally safe and well tolerated with no increase in the incidence of adverse events observed in the higher dose treatment groups. The majority of treatment-related adverse events were mild or moderate in severity and were similar to or lower than those reported in prior botulinum toxin studies in adult upper limb spasticity.

“I am very proud of our team and their efforts to successfully complete our Phase 2 trial during what has proven to be a very challenging time for trial enrollment and follow up,” said Mark J. Foley, President and Chief Executive Officer at Revance. “Although we reduced the subject enrollment size in response to COVID-19 concerns, we were able to generate sufficient data to inform our dosing strategy for our Phase 3 program, while also demonstrating a long duration profile that is consistent across our therapeutic and aesthetic clinical programs. Our next step is to schedule an end-of-Phase 2 meeting with the FDA prior to finalizing a Phase 3 program. I want to thank the patients, investigators, CROs and the Revance team for their time and commitment in making this trial possible.”

Conference Call

The company plans to discuss the results today during its Fourth Quarter / Year End 2020 Earnings Conference Call at 4:30 p.m. ET. Individuals interested in listening to the conference call may do so by dialing [phone] for domestic callers, or [phone] for international callers and reference conference ID: 1678310; or from the webcast link in the investor relations section of the company’s website at: www.revance.com. A replay of the call will be available beginning February 22, 2021 at 4:30 p.m. PT/7:30 p.m. ET to February 23, 2021 at 4:30 p.m. PT/7:30 p.m. ET. To access the replay, dial [phone] or [phone] and reference conference ID: 1678310.