Revance Completes Enrollment in Phase 3 Pivotal Trials of RT002 Injectable for the Treatment of Glabellar (Frown) Lines
March 07 2017 - 8:10AM
Business Wire
SAKURA Program Topline Results on Track to
Report Fourth Quarter 2017
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170307005866/en/
Investors:Revance TherapeuticsJeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellanAmi Bavishi,
212-213-0006abavishi@burnsmc.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Aug 2024 to Sep 2024
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Sep 2023 to Sep 2024