Revance Therapeutics, a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, 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.”
In addition to SAKURA 1 and SAKURA 2, a long-term safety trial, SAKURA 3, is fully enrolled and is expected to be completed in the second half of 2018. Assuming successful completion of SAKURA 3, the company plans to submit a Biologics License Application in the first half of 2019 and, pending approval by the FDA, launch RT002 in the U.S. in 2020.
“Both SAKURA 1 and SAKURA 2 show RT002 delivers consistent long-acting performance, which is unprecedented for a neuromodulator given what we have seen over the last 30 years,” said Jean D. Carruthers, M.D., a SAKURA lead investigator and pioneer in the use of botulinum toxin for both aesthetic and therapeutic conditions, and Clinical Professor, University of British Columbia. “The data confirm the enhanced effect of this new neuromodulator both in its longevity and patient response. With just two treatments a year, RT002 has the potential to change the landscape in neuromodulator therapy.”
Treatment of glabellar lines is the most popular aesthetic procedure for an injectable neuromodulator, accounting for nearly a third of the $3.6 billion in global neuromodulator sales in 2016. Patients and physicians alike identify duration as the most important attribute of an injectable aesthetic treatment, market research shows. 1
“Patients in my practice are very savvy – not only do they want their neuromodulator treatment to give them great results, they also want the look to last as long as possible,” said Joely Kaufman-Janette, M.D., Skin Associates of South Florida, and a SAKURA investigator. “I am very excited about the results of the SAKURA trials since RT002 appears to provide the look my patients desire over a six-month period, which is remarkable and will fulfill a significant need among my patients.”