Revance Therapeutics, Inc. announced publication in the peer reviewed journal, Dermatologic Surgery of positive data from its Phase 1/2 study of RT002 injectable botulinum toxin type A for the treatment of moderate to severe glabellar (frown) lines. RT002 is Revance's proprietary, injectable botulinum toxin investigational product that incorporates the patented TransMTS® technology and is designed to provide a longer lasting duration of effect. Initial results from the study were announced last April and showed RT002 met its efficacy and safety endpoints with an extended duration of action.

The open-label, dose escalating, Phase 1/2 study enrolled 48 adults in four cohorts. All subjects had Severe or Moderate wrinkles at baseline, measured using the 4-point Global Line Severity Scale (GLSS). Clinical investigators rated 96% of subjects with None or Mild wrinkle severity at maximum frown 4 weeks post-treatment using the GLSS.

At the same time point, 83% of the subjects assessed themselves as achieving None or Mild wrinkles at maximum frown. In the final cohort, the only one where duration of effect was measured, RT002 achieved a median duration of 29.4 weeks, or 7 months, based on both investigator and subject assessments. In this final cohort, 60% of subjects maintained None or Mild wrinkle severity at 6 months.

RT002 was well tolerated, and there was no evidence of spread beyond the treatment site at any dose; additionally, adverse event rates did not change in frequency, severity, or type with increasing doses. Based on the results of this study and previous findings from pre-clinical data, Revance initiated BELMONT, a Phase 2 active comparator study. BELMONT is a double-blind, dose ranging, active and placebo controlled multi-center study.

Top-line data is expected in late 2015.