NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced the completion of patient enrollment in two pivotal trials of the company’s SAKURA Phase 3 program for its investigational drug candidate DaxibotulinumtoxinA for Injection (RT002) for the treatment of moderate to severe glabellar lines in adults. Glabellar line treatment is the most popular aesthetic procedure for botulinum toxin and is estimated to have represented nearly $1 billion of the global market in 2015. Revance’s Phase 3 program is comprised of two pivotal trials evaluating the efficacy, safety and duration of RT002, as well as a long-term safety trial, the latter of which continues to enroll patients. The company expects to report topline results from both pivotal Phase 3 trials in the fourth quarter of 2017.
“Our SAKURA program is designed to confirm RT002’s potential to deliver high response rates and long lasting treatment of frown lines,” said Dan Browne, co-founder, President, and Chief Executive Officer at Revance. “We believe RT002 will help reduce the number of annual treatments that could potentially lead to greater patient satisfaction. Data presented last year from our BELMONT Phase 2 study demonstrated a six-month median duration of effect. This compares favorably to duration of three to four months for the treatment of glabellar lines noted in the labels of commercially available neurotoxins. This pivotal Phase 3 program is expected to build on the BELMONT results and establish RT002 as the first long-lasting neuromodulator.”
SAKURA Phase 3 Clinical Program
The company's Phase 3 clinical program includes two randomized, double-blind, placebo-controlled pivotal trials to evaluate the safety and efficacy of a single administration of RT002 for the treatment of moderate to severe glabellar lines in adults. The pivotal trials have enrolled a total of approximately 600 subjects at multiple sites in the United States and Canada. In both trials, subjects have been randomized in a 2:1 ratio to either the RT002 or placebo treatment groups, respectively. Post-treatment, subjects will be followed for at least 24 weeks and up to 36 weeks.
The primary efficacy endpoint of the pivotal trials will be a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales, at maximum contraction (frown), at Week 4. Duration of the reduction of severity of the glabellar lines will be assessed as a secondary efficacy endpoint in the Phase 3 pivotal trials.
In addition to the two pivotal trials, the Phase 3 program includes a long-term, open-label safety trial, which is designed to evaluate the long-term safety of RT002 for the treatment of moderate to severe glabellar lines in adults following both single and repeat treatment administration. The long-term safety trial is expected to enroll approximately 1,500 subjects at multiple sites in the US and Canada. Depending on the number of treatments and duration of follow-up, a subject may be on trial for a maximum of 84 weeks.
Additional information about the SAKURA Phase 3 program, including subject eligibility criteria, is available at www.clinicaltrials.gov.
About Revance Therapeutics, Inc.
Revance, a Silicon Valley-based biotechnology company, is committed to the advancement of remarkable science. The company is developing a portfolio of products for aesthetic medicine and underserved therapeutic specialties, including dermatology, orthopedics and neurology. Revance's science is based upon a proprietary peptide technology, which when combined with active drug molecules, may help address current unmet needs. Revance's initial focus is on developing daxibotulinumtoxinA, the company's highly purified botulinum toxin, for a broad spectrum of aesthetic and therapeutic indications, including facial wrinkles and muscle movement disorders.
The company's lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis with the potential to be the first long-acting neuromodulator. The company holds worldwide rights for all indications of RT002 injectable and RT001 topical and the pharmaceutical uses of its proprietary peptide technology platform. More information on Revance may be found at www.revance.com.
"Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, 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, 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; and statements about our ability to obtain regulatory approval; 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 risks that interim results are not indicative of final results and 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 annual report on Form 10-K filed February 28, 2017. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.