Revance Announces Late-Breaking Podium Presentation of Positive 6-Month Duration Results for BELMONT Phase 2 Active Comparator Study of Injectable RT002 at the 74th Annual Meeting of the American Academy of Dermatology
Revance Therapeutics, Inc
39 minutes ago
GlobeNewswire
- Findings confirm statistically significantly greater duration of effect for RT002 compared to BOTOX® Cosmetic -
- 40U dose of RT002 planned to enter pivotal Phase 3 study in the second half of 2016 -
NEWARK, Calif., March 05, 2016 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that clinical results from the company’s BELMONT Phase 2 active comparator study of DaxibotulinumtoxinA for Injection (RT002) were reported in a podium presentation at the American Academy of Dermatology (AAD) annual meeting, which is being held in Washington, DC, March 4-8, 2016. Confirming interim clinical results previously reported in October 2015, all three study dose levels of RT002 achieved the Phase 2 study’s primary efficacy measurement demonstrating at least 1-point improvement in frown lines based on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale at 4 weeks. This measurement showed a statistically significantly greater response as compared to placebo for each dose level of RT002 (100% investigator-determined response for all three RT002 dose levels vs. 3% response for placebo). In addition, Revance’s study demonstrated a 6-month median duration of effect for RT002 based upon at least 1-point improvement in glabellar lines at maximum frown on the IGA-FWS scale.
For the mid-dose level of RT002 Injectable 40U, the duration of effect was statistically significantly greater (23.6 weeks) compared to BOTOX® Cosmetic (BOTOX® 20U) (18.8 weeks; p=0.02). RT002 40U is the dose Revance intends to bring forward in Phase 3 clinical studies, which are expected to commence in the second half of 2016.
For RT002 Injectable 40U, investigator assessment of None or Mild wrinkles was statistically superior at the majority of time points when compared to BOTOX® Cosmetic. As an example, at 6 months, 31% of subjects receiving RT002 40U maintained None or Mild wrinkles compared to 12% receiving BOTOX® (p<0.05).
Across all cohorts, RT002 appeared to be generally safe and well-tolerated. Adverse events were predominantly localized, transient, and mild. There were no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated.
