Revance Therapeutics Inc (NASDAQ: RVNC) is a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions. On Tuesday shares of the Revance jumped about 10% a after the company announced its next-generation neuromodulator DaxibotulinumtoxinA for Injection (RT002) delivered positive top-line results in alleviating moderate-to-severe glabellar lines in two pivotal SAKURA Phase 3 trials. RT002 appeared generally safe and well-tolerated in both studies.
If approved by the U.S. Food and Drug Administration (FDA), Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months. Marketed neuromodulators have demonstrated duration of three to four months in treating glabellar lines.
Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines, i.e., the frown lines or wrinkles between the brows. The percent of RT002-treated patients who had none or mild wrinkles and achieved at least a two-point improvement from baseline on both validated physician and patient assessments were 73.6 percent in SAKURA 1 and 74.0 percent in SAKURA 2 compared to placebo (p < 0.0001) at Week 4. Also at that time point, 88 percent of RT002-treated patients in SAKURA 1 and 91 percent of RT002 patients in SAKURA 2 said they were very satisfied or satisfied with their treatment experience.
All secondary endpoints measuring reduction in severity of glabellar lines with RT002 compared to placebo were highly statistically significant at every time point evaluated to 24 weeks. On an additional key secondary endpoint, median duration for patients treated with RT002 to return to baseline wrinkle severity was nearly 27 weeks (SAKURA 1: 27.7 weeks and SAKURA 2: 26.0 weeks) as assessed by both physicians and patients.
"We are extremely pleased with these positive SAKURA top-line results, which reinforce the findings from the BELMONT Phase 2 active-comparator study. These results demonstrate it is scientifically and clinically possible to create a significantly longer-acting neuromodulator with a duration of six months, compared to three to four months observed with currently available products," said Dan Browne, Co-Founder, President and Chief Executive Officer of Revance Therapeutics. "We look forward to providing patients and healthcare professionals with what we believe is a new, next-generation, long-acting neuromodulator for the treatment of glabellar lines."