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 initiation of subject dosing in 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 neurotoxin cosmetic procedure market in 2015. Topline clinical results from Revance’s pivotal trials are expected in the fourth quarter of 2017.
“The SAKURA Phase 3 program is designed to offer additional confirmation of RT002’s profile as a long-lasting neurotoxin,” said Dan Browne, co-founder, President, and Chief Executive Officer at Revance. “We believe RT002 has the potential to deliver higher response rates in patients with frown lines over an extended period of time compared to study results from the commercially available botulinum toxins, as supported by the results of our Phase 2 BELMONT program reported earlier this year.”
“I have been working clinically with botulinum toxins for more than 30 years. RT002 represents possibly the most significant advance I’ve seen in longevity of neuromodulator effect,” said Jean D. Carruthers, MD, Clinical Professor, at University of British Columbia, Medical Director at Jean Carruthers Cosmetic Surgery Inc., a lead investigator for the SAKURA and BELMONT trials, and a pioneer in the cosmetic use of botulinum toxin. “I believe my patients will respond very favorably to a new botulinum toxin option that may provide significant wrinkle reduction and extend the window between treatments.”
In March 2016 at the American Academy of Dermatology (AAD) annual meeting, Revance reported positive results of the company’s BELMONT Phase 2 active comparator study of RT002, which demonstrated that all three dose levels of RT002 (20 Units, 40 Units and 60 Units) achieved the Phase 2 study’s primary efficacy measurement demonstrating at least 1-point improvement in frown lines based on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale at 4 weeks. This measurement showed a statistically significantly greater response as compared to placebo for each dose level of RT002 (100% investigator-determined response for all three RT002 dose levels vs. 3% response for placebo).
In addition, Revance’s BELMONT study demonstrated a 6-month median duration of effect for RT002, based upon at least 1-point improvement in glabellar lines at maximum frown on the IGA-FWS scale. At 24 weeks, RT002 at a 40 Unit dose continued to deliver clinically meaningful higher response rates versus the active comparator in the study, BOTOX® Cosmetic at a 20 Unit dose. Across all cohorts, RT002 appeared to be generally safe and well-tolerated. Adverse events were predominantly localized, transient, and mild. There were no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated.
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 are expected to enroll a total of approximately 600 subjects at multiple sites in the United States and Canada. In both trials, subjects will be 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 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 planned 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. 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, will be posted shortly at www.clinicaltrials.gov.
About Glabellar Lines
The glabella is the skin between the eyebrows and above the nose. Glabellar lines (often called “frown lines”) are those vertical lines that develop between the eyebrows and may appear as a single vertical line or as two or more lines and may also appear angled towards the inner corners of the eyebrows. When you frown, the muscles of the lower forehead contract in a downward direction causing the skin between the eyebrows to crease. Lines are formed by the repeated action of frowning due to the lack of elasticity in the skin. Age, sun exposure, and genetics are contributing factors. Botulinum toxin is used to block the nerve impulses, temporarily paralyzing the muscles that cause the frown lines, giving the skin a smoother, more refreshed appearance.
Based on data from Global Industry Analysts, Inc., the global market for aesthetic treatments with neurotoxins represented about a $1.4 billion market in 2015, and according to the American Society for Aesthetic Plastic Surgery, botulinum toxin treatment is the number one nonsurgical cosmetic procedure in the United States. Glabellar line treatment represents nearly $1 billion of that market.
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 TransMTS® 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 neurotoxin. The company holds worldwide rights for all indications of RT002 injectable and RT001 topical and the pharmaceutical uses of the TransMTS technology platform. More information on Revance may be found at www.revance.com.
“Revance Therapeutics,” TransMTS®, “Remarkable Science Changes Everything,” 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, 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 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 November 4, 2016. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.