DaxibotulinumtoxinA for Injection (DAXI) demonstrated prolonged duration of response for glabellar line reduction
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company pioneering new innovations in neuromodulator products for aesthetic and therapeutic indications, today announced the publication of the pooled data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (SAKURA 1 and SAKURA 2) evaluating Revance’s long-acting neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI) for the treatment of moderate to severe glabellar (frown) lines. The pooled results were published in the Journal of the American Academy of Dermatology (JAAD).
The SAKURA 1 and SAKURA 2 studies were identical in design and evaluated the safety and efficacy of a single administration of DAXI. The data showed that the primary endpoint of a 2-point composite response at week 4 was achieved in 73.8% of patients in the pooled DAXI group versus 0.5% in the pooled placebo group (p<0.0001 [difference of 73.5%, 95% CI: 69.2%–77.9%]). The proportion of responders to DAXI was similar regardless of whether baseline glabellar line severity had been moderate (75.4%) or severe (71.2%).
"I am very pleased by these results, particularly because the median time to return to baseline wrinkle severity was 27.1 weeks, which could translate to approximately two treatments per year," said co-author Dr. Nowell Solish, Cosmetic Dermatologist and Director of Dermatologic Surgery at the University of Toronto.
The pooled results were consistent with the findings from the earlier dose-ranging Phase 2 BELMONT study which demonstrated that DAXI for injection offers high response rates in the treatment of glabellar lines with a median duration of response of 24 weeks.
"In addition to showing superior efficacy compared to placebo in the SAKURA pivotal studies, DAXI was observed to have a 24 week duration of effect and a greater than 90% response in patients beginning at week 1, while being generally well tolerated, all of which are important attributes for neuromodulator products," said Roman Rubio, Senior Vice President of Clinical Development at Revance. "The acceptance of the pooled data in the Journal of the American Academy of Dermatology (JAAD) further emphasizes the strength of the SAKURA Phase 3 clinical trial program."
Among 609 subjects enrolled in both SAKURA 1 and SAKURA 2, pooled data showed DAXI was significantly more effective than placebo in reducing glabellar line severity and subjects maintained none or mild glabellar line severity for a median of 24 weeks. DAXI was also generally well tolerated and no new safety signals were observed.
The SAKURA program is the largest Phase 3 aesthetic neuromodulator program ever conducted for the treatment of glabellar frown lines. Additional results from the SAKURA 1 and 2 studies were recently published in Plastic and Reconstructive Surgery (PRS) and results from SAKURA 1, 2 and 3 were presented at the American Society for Dermatologic Surgery 2019 (ASDS) Annual Meeting in Chicago. The full publication can be accessed via Revance’s website under the Our Science section or at https://www.revance.com/clinical-information/?category=aesthetics.
About Revance Therapeutics, Inc.
Revance Therapeutics is a Silicon Valley-based biotechnology company, pioneering new innovations in neuromodulators for aesthetic and therapeutic indications. Revance’s lead product candidate, DaxibotulinumtoxinA for Injection (DAXI), combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DAXI in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DAXI in forehead lines and lateral canthal lines (crow’s feet), as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis, with plans to study migraine. Beyond DAXI, Revance has begun development of a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
"Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
BOTOX® is a registered trademark of Allergan, Inc.
This press release contains forward-looking statements, including statements related to the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates, including but not limited to initiation and design of clinical studies for current and future indications, related results and reporting of such results; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans; and statements about the timing and our ability to obtain regulatory approval and launch products, including with respect to DAXI for Injection to treat glabellar (frown) lines; potential benefits of our drug product candidates and our technologies; and our ability to compete in the neuromodulator market. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations and achieve our goals; our plans to research, develop, and commercialize our drug product candidates; our ability to successfully compete with treatments and therapies, our ability to achieve, and the rate and degree of market acceptance and adoption of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully manufacture and commercialize our drug product candidates and the timing of commercialization activities; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance’s periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risk Factors" of our quarterly report on Form 10-Q filed November 4, 2019. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.