Revance Announces Publication of SAKURA 1 and SAKURA 2 Results in Plastic and Reconstructive Surgery
Additionally, frown lines did not return to their pre-treatment severity for at least 2628 weeks for half of the patients treated.
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company pioneering new innovations in neuromodulators for aesthetic and therapeutic indications, today announced the publication of results from the Phase 3 studies, SAKURA 1 and SAKURA 2, in Plastic and Reconstructive Surgery (PRS), the peer reviewed Journal of the American Society of Plastic Surgeons. These two Phase 3 studies evaluated Revance’s long-acting neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI), for the treatment of moderate and severe glabellar lines.
This manuscript presents the findings from SAKURA 1 and 2 side-by-side, which demonstrate the consistency of efficacy and safety results evident between the two pivotal studies, as well as the reproducibility of these outcomes with DAXI across patients and clinical trial sites.
Both SAKURA 1 and SAKURA 2 demonstrated that half of the patients treated maintained none or only mild frown lines for at least 24 weeks (approximately 6 months), after a single treatment. Additionally, frown lines did not return to their pre-treatment severity for at least 26–28 weeks for half of the patients treated.
“The publication in PRS highlights the quality of the Phase 3 clinical data and underscores how DAXI unlocks the true potential for a next generation neuromodulator product,” said Mark Foley, President and Chief Executive Officer of Revance Therapeutics, Inc.
SAKURA 1 and SAKURA 2 were identically designed studies, conducted to evaluate consistency of results. Both trials demonstrate that DAXI may offer a prolonged duration of none or mild response (median ≥ 24 weeks) and is generally well tolerated. The most common side effects that developed in response to treatment were headache (5.9%–7.0%), pain at the injection site (2.4%–5.0%) and drooping of the eyelid (eyelid ptosis; 2.0%–2.5%).
“The SAKURA program is the largest ever botulinum toxin type A clinical trial program in subjects with moderate or severe glabellar lines. These data demonstrated a clinically meaningful benefit with a median duration of more than 24 weeks,” said lead author Jean D. Carruthers, MD, who has served as an investigator for multiple FDA-approved neuromodulators and is a clinical professor at the University of British Columbia. “The prolonged duration of clinical benefit with DAXI can help sustain efficacy between treatments and lessen the frequency of re-treatment, which could significantly improve patient satisfaction. DAXI may very well change patients’ expectations for a neuromodulator treatment.”
Additional results from the Phase 3 studies, SAKURA 1, 2, and 3, were presented last week 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, delivering unprecedented efficacy and long-lasting duration of effect, 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.
Forward-Looking Statements
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, including the timing and results of the SAKURA 3 study of DAXI for Injection, 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 our ability to obtain regulatory approval, including the timing of potential BLA filing for DAXI for Injection to treat glabellar (frown) lines; and potential benefits of our drug product candidates and our technologies. 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; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance 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 commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; 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 August 6, 2019. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.
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