Revance Announces Late-Breaking Podium Presentation of Positive 6-Month Duration Results for BELMONT Phase 2 Active Comparator Study of Injectable RT002 at the 74th Annual Meeting of the American Academy of Dermatology
- Findings confirm statistically significantly greater duration of effect for RT002 compared to BOTOX® Cosmetic -
- 40U dose of RT002 planned to enter pivotal Phase 3 study in the second half of 2016 -
- For the mid-dose level of RT002 Injectable 40U, the duration of effect was statistically significantly greater (23.6 weeks) compared to BOTOX® Cosmetic (BOTOX® 20U) (18.8 weeks; p=0.02). RT002 40U is the dose Revance intends to bring forward in Phase 3 clinical studies, which are expected to commence in the second half of 2016.
- For RT002 Injectable 40U, investigator assessment of None or Mild wrinkles was statistically superior at the majority of time points when compared to BOTOX® Cosmetic. As an example, at 6 months, 31% of subjects receiving RT002 40U maintained None or Mild wrinkles compared to 12% receiving BOTOX® (p < 0.05).
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.
Also covered within the presentation was a separate study investigating the impact of dosing of BOTOX® Cosmetic on duration of effect. This prior study showed that increased dosing did not result in meaningfully longer duration, an important finding underscoring the need for an alternative, longer-duration treatment.
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.
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About RT002 Injectable
DaxibotulinumtoxinA for Injection (RT002) combines Revance's proprietary, pure 150kD botulinum toxin type A molecule, without any accessory proteins or animal derived components, with Revance's patented TransMTS® peptide technology. RT002 is designed to offer more targeted delivery to the intended treatment sites, while reducing its spread beyond the site of local injection for a long-lasting effect. RT002 is in clinical development for the treatment of glabellar (frown) lines and for cervical dystonia, and has the potential to address additional therapeutic indications in movement disorders, pain, urology, and other potential uses where targeted delivery is required or long duration is desired.
Revance's journey to market starts with the neurotoxin daxibotulinumtoxinA, the company's highly purified botulinum toxin type A. The TransMTS technology is used in the delivery of botulinum toxin through two novel drug product candidates: DaxibotulinumtoxinA Topical Gel (RT001) that permits needle-free application, and DaxibotulinumtoxinA for Injection (RT002), which is designed to enable targeted administration and long-lasting effect. Revance is developing RT001 and RT002 for a broad spectrum of aesthetic and therapeutic indications, including facial wrinkles, excessive sweating and muscle movement disorders. The company holds worldwide rights for all indications of RT001, RT002 and the TransMTS technology platform. Beyond botulinum toxin, Revance expects the TransMTS technology can be applied to transdermal, mid-dermal or deep tissue delivery of a variety of other macromolecules. More information on Revance can be found at www.revance.com.
"Revance Therapeutics", TransMTS®, "Remarkable Science Changes Everything", and the Revance logo are registered trademarks of
Forward Looking Statements
This press release contains forward-looking statements, including statements related to Revance Therapeutics' investigational drug product candidates, including but not limited to statements about our business strategy, clinical development, timeline and other goals and market for our anticipated products, plans and prospects and statements about 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 annual report on Form 10-K filed March 4, 2016. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.
Revance Therapeutics, Inc. Jeanie Herbert(714) 325-3584 email@example.com Trade Media: Nadine Tosk (504) 453-8344 firstname.lastname@example.org
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