Revance says RT002 met primary, secondary endpoints in SAKURA trials
Revance Therapeutics (RVNC) announced its next-generation neuromodulator Daxibotulinumtoxin for Injection, or 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, 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 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 as assessed by both physicians and patients.
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.
Shares of Allergan (AGN) are sliding in pre-market trading following the news. If approved by the U.S. FDA, Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months, the company said. 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, it added.
RVNC closed at $26.00, it last traded at $33.75.
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