NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company pioneering new innovations in neuromodulators for aesthetic and therapeutic indications, today announced three oral presentations at the American Society for Dermatologic Surgery (ASDS) 2019 Annual Meeting to be held in Chicago, October 24-27, 2019. Presented data will showcase Revance’s investigational product DaxibotulinumtoxinA for Injection (DAXI), a novel botulinum toxin type A in clinical development for the treatment of moderate and severe glabellar lines.
“We are excited to present results from our SAKURA program, the largest Phase 3 clinical development program to date,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “Patient experiences with neuromodulators have remained largely unchanged since botulinum toxin type A treatments were introduced 30 years ago. At ASDS, we are presenting data that sets new standards in injectable facial aesthetics and advances our mission of transforming the patient experience.”
In one oral presentation, a pooled analysis of the two SAKURA 1 and 2 pivotal studies and the SAKURA 3 open label safety study showed that the magnitude and duration of clinical efficacy of DAXI between those subjects with prior botulinum toxin A (BoNT-A) treatment and those who were treatment naïve are similar, as was the safety profile. This suggests that a subject’s previous experience with BoNT-A does not impact investigator assessment or bias subjects in their ability to appropriately assess their response to treatment in a clinical trial environment.
“I think it is quite interesting to note the results from the pooled analyses, as they illustrate that previous BoNT-A treatment may not be a factor in the clinical efficacy or duration of effect of DaxibotulinumtoxinA for Injection,” said lead author Joel L. Cohen, MD of AboutSkin Dermatology in Colorado. “These data give me confidence that DAXI will be an appropriate, effective and predictable treatment option for patients who may switch from another BoNT-A product, as well as those that are new to neuromodulators.”
Additional data being unveiled from the SAKURA 3 open-label safety study in an oral presentation showcase the finding that a clinically measurable improvement (≥1 grade change) in glabellar lines was observed in over 96% of patients at week four after treatment with DAXI, and that this result was sustained for at least 28 weeks (~7 months) in at least half of the patients.
The third oral presentation highlights the safety and efficacy findings from the SAKURA 3 study with DAXI for glabellar lines in which over 2,600 patients were treated. This study showed that the clinical responses to DAXI for both response rates and duration of effect were highly consistent from treatment cycle to treatment cycle and no new safety concerns were observed.
Revance’s scheduled presentations are:
- DaxibotulinumtoxinA for injection is similarly effective in experienced BoNT patients and in those naïve to treatment. Friday, Oct 25 from 3:15-3:20pm during the 1:30-3:30pm Oral Abstracts: Cosmetic Dermatologic Surgery session. Presenter: Joel L. Cohen, Dermatologist at AboutSkin Dermatology and DermSurgery PC, Greenwood Village, CO.
- Results of a large open label safety study of DaxibotulinumtoxinA for Injection in Glabellar Lines. Saturday, Oct 26 from 1:47-1:50 pm during the 1:45-2:45 pm Cosmetic Abstract session. Presenter: Dr. Sabrina Guillen-Fabi, Dermatologist and Associate at Cosmetic Laser Dermatology, San Diego, Volunteer Assistant Clinical Professor, University of California San Diego, CA, USA.
- Clinically Measurable Improvement in Glabellar Lines Wrinkle Severity from Three Phase 3 Studies of DaxibotulinumtoxinA for Injection. Thursday, Oct 24 from 2:08-2:10pm during the 1:30-2:25pm Oral Abstracts session. Presenter: Kavita Mariwalla, Dermatologist at Mariwalla Dermatology, West Islip, NY, USA.
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.
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 RT002, 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 RT002 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.