Revance Reports Positive 6-Month Duration for RT002 in BELMONT Study

Revance Therapeutics, Inc., shared positive 24-week results from its multi-center BELMONT Phase 2 active comparator study of injectable RT002. The ongoing study for the treatment of glabellar lines in 268 subjects compared the safety, efficacy, and duration of effect of three doses of RT002 against placebo, and current market leader, BOTOX Cosmetic/VISTABEL®. The topline interim data showed that RT002, a botulinum toxin type A investigational drug product candidate for injection, achieved its primary efficacy measurement for all three doses at four weeks. The study demonstrated 6-month RT002 median duration of effect based upon at least 1-point improvement in glabellar lines at maximum frown on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale. 

Key Interim Results of the BELMONT Trial

• The four-week primary efficacy measurement of at least 1-point improvement in frown lines based on the IGA-FWS scale for all three doses (20 Units, 40 Units and 60 Units) of RT002 was highly statistically significant (p < 0.001) as compared to placebo for all three doses.
• All doses of RT002 achieved a 100 percent response rate of at least 1-point improvement in frown lines, based on the IGA-FWS scale at four weeks versus a 95 percent response rate for BOTOX Cosmetic.
• RT002 efficacy showed a dose response. RT002 40U was statistically significant to BOTOX Cosmetic on all three responder definitions for the IGA-FWS median duration of effect. On the IGA-FWS duration of response. RT002 demonstrated a 23.6-week median duration versus BOTOX Cosmetic with an 18.8-week median duration (p=0.020).  
• More than twice as many RT002 40U and 60U subjects in the study maintained none or mild wrinkles on the IGA-FWS scale as compared to BOTOX Cosmetic at Week 16 (p≤0.002).
• Subject-reported outcomes were consistent with investigator findings of duration and efficacy of RT002.
• Across all cohorts, RT002 appeared to be generally safe and well-tolerated. Adverse events were generally mild, localized and transient. For RT002 20U and 40U, no subjects experienced ptosis (eyelid droop). There were no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated.

"The BELMONT study, using some of the top botulinum toxin injectors, was designed to further demonstrate the effectiveness and duration of RT002 versus BOTOX Cosmetic, the current market leader. The interim results are compelling," said Dan Browne, President and Chief Executive Officer at Revance. "The results clearly support that 40U is the right dose to take forward. We plan to report BELMONT's final study results and to conduct an End-of-Phase 2 meeting with the FDA in the first half of next year. We expect to begin Phase 3 clinical studies in the second half of 2016. Assuming the duration observed in our Phase 3 studies is consistent with the results reported today, we believe the collective data should support a 6-month duration label."

"Botulinum toxin use for frown lines is one of the most popular procedures requested by patients in my practice," said Jean D. Carruthers, MD, Clinical Professor, at University of British Columbia, Medical Director at Jean Carruthers Cosmetic Surgery Inc., a lead investigator for the RT002 BELMONT trial, and one of the world's foremost leaders in aesthetic botulinum toxin use. "With BELMONT, Revance has done something that has never been done before in a neurotoxin Phase 2 clinical program in terms of demonstrating superior duration of effect in an active comparator study. The 100 percent achievement of at least a 1-point improvement on the Facial Wrinkle Severity Scale seen as early as two weeks in all dose groups is impressive. The 6-month duration makes this a likely game changer in our aesthetic practices. Currently many of my patients come in year after year on a quarterly basis for botulinum toxin injections. With RT002 they could get their botulinum toxin treatments on a bi-annual basis, which conveniently coincides with a large percentage of my patients who receive fillers or other treatments for pan facial uses."