- Topline Results of Pivotal Efficacy Trials
Anticipated in Fourth Quarter 2017 -
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161207005418/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
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