June 13, 2016
In REALISE 1, DaxibotulinumtoxinA Topical Gel (RT001) did not achieve its co-primary and other endpoints. The co-primary efficacy endpoints in the trial were composite measurements of 2-point or greater and 1-point or greater improvement in lateral canthal lines between baseline and 28 days after treatment, as graded by the Investigator's Global Assessment of Lateral Canthal Lines (IGA-LCL) and the Patient Severity Assessment (PSA). RT001 topical generally appeared to be well-tolerated in this study.
"We are disappointed with the results of the REALISE 1 trial. The data was unambiguous, and we do not plan to continue development of RT001 topical for crow's feet. Based on these results, we have also decided not to pursue the current clinical development plan for RT001 in axillary hyperhidrosis. We are grateful to all the patients and investigators
for their participation in the REALISE 1 trial," said
At the end of
Phase 3 Trial Design - REALISE 1
The Phase 3 trial was a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of DaxibotulinumtoxinA Topical Gel (RT001) for the treatment of moderate to severe lateral canthal lines. A total of 450 adult patients were enrolled at seven sites in
DaxibotulinumtoxinA for Injection (RT002) Pipeline Programs
Planned Phase 3 Program for the Treatment of Glabellar (Frown) Lines - In the
Phase 2 Trial for the Treatment of Cervical Dystonia - Revance's Phase 2 dose-escalating study of RT002 injectable for the treatment of cervical dystonia is enrolling patients into Cohort 2, following the encouraging, preliminary results from a planned six-week safety review for patients enrolled in Cohort 1 (n=12) of the study. Revance expects to share interim results from this study in the second half of 2016.
Revance management will host a conference call and webcast today,
A replay of the call will be available beginning
Revance is 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 holds worldwide rights for all indications of DaxibotulinumtoxinA Topical Gel (RT001), DaxibotulinumtoxinA for Injection (RT002) and the TransMTS technology platform. Beyond botulinum toxin, Revance believes 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
BOTOX® is a registered trademark of
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to: statements about our business strategy, our investigational drug product candidates, expected efficacy of our drug product candidates, 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 quarterly report on Form 10-Q filed on
Revance Therapeutics Jeanie Herbert(714) 325-3584 email@example.com Burns McClellan Ami Bavishi(212) 213-0006 firstname.lastname@example.org Trade Media: Nadine Tosk (504) 453-8344 email@example.com
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