- RT002 injectable 40-unit dose under study for
the treatment of glabellar lines demonstrated statistical and
clinical superiority over BOTOX* Cosmetic for a range of efficacy
outcomes and achieved six-month duration of effect -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in treating
aesthetic and therapeutic conditions, today announced the
electronic publication (ePub) of its completed BELMONT Phase 2
trial results in the peer-reviewed journal, Dermatologic Surgery.
Positive 24-week results for BELMONT, a Phase 2 active comparator,
double-blinded, placebo-controlled, multi-center trial of
DaxibotulinumtoxinA for Injection (RT002) for the treatment of
glabellar (frown) lines, were first announced in October 2015.
SUMMARY OF RESULTS
- SAFETY: All dose levels of RT002
appeared to be generally safe and well-tolerated.
- EFFICACY: When compared to
placebo, all dose levels of RT002 achieved highly statistically
significant efficacy at Week 4 (p < 0.001) based on investigator
and patient reporting. When compared to 20U of onabotulinumtoxinA
(BOTOX* Cosmetic/VISTABEL*), the 40U dose of RT002 showed
statistical and clinical superiority over onabotulinumtoxinA for a
range of efficacy outcomes, as rated by investigators, for none or
mild and 1- and 2-point improvement in glabellar wrinkle severity.
- Response Rate: The proportion of
subjects with glabellar line severity rated by investigators as
none or mild with 40U of daxibotulinumtoxinA was more than double –
and significantly greater than that with 20U of onabotulinumtoxinA
at weeks 16 and 24 (67% vs 32% at Week 16 {p=0.002} and 31% vs. 12%
at Week 24 {p=0.041}, respectively), according to the Investigator
Global Assessment- Facial Wrinkle Severity (IGA-FWS) score at
maximum frown. Similarly, the proportion of subjects rated by
investigators as improved per the Global Aesthetic Improvement
Scale (GAIS) at 16 and 24 weeks was greater for 40U of
daxibotulinumtoxinA than 20U of onabotulinumtoxinA (97% vs 81% at
Week 16 {p<0.05} and 44% vs. 19% at Week 24 {p<0.05},
respectively).
- Duration: The median duration of
response (at least a 1-point improvement for baseline in IGA-FWS
score at maximum frown) was longer with daxibotulinumtoxinA (20.0,
23.6 and 20.9 weeks for 20U, 40U and 60U, respectively) than for
onabotulinumtoxinA (18.8 weeks) or placebo (0.0 weeks) (p< .001
for all botulinum toxins vs placebo and p=.030 for
daxibotulinumtoxinA 40U vs onabotulinumtoxinA).
The publication’s key conclusion stated that of the three dose
ranges, the 40U dose of RT002 had the best risk/benefit profile,
exhibiting an absence of ptosis as an adverse event, a
significantly greater response rate, and a significantly longer
duration of response (median of 24 vs 19 weeks; p=.030) compared to
onabotulinumtoxinA. The abstract and access to the article in
Dermatologic Surgery can be retrieved via this link: BELMONT
Abstract.
“The BELMONT trial results are exciting, in that they show RT002
injectable could be the first new generation botulinum toxin
treatment offering patients higher response rates and a longer
duration of response without compromising safety or tolerability,”
said trial investigator Jean D. Carruthers, MD, Clinical Professor,
at University of British Columbia, Medical Director at Jean
Carruthers Cosmetic Surgery Inc., and one of the world’s foremost
leaders in aesthetic botulinum toxin use. “Treatment of glabellar
lines represents the largest use of botulinum toxin in aesthetics
practice today. I believe my patients would be thrilled to benefit
from enduring wrinkle reduction over a six-month period. To my
knowledge, RT002 is the only neuromodulator that has shown the
potential to be meaningfully longer acting than the market
leader.”
Added Dan Browne, President and Chief Executive Officer at
Revance, “The emergence of a differentiated, new neuromodulator is
significant to physicians and patients alike. RT002 has the
potential to provide a better aesthetic experience. Acceptance in a
peer-reviewed publication, such as Dermatologic Surgery, validates
the significance of our BELMONT results and underscores the
confidence we have in our SAKURA Phase 3 program using RT002
injectable for the treatment of frown lines. The two pivotal trials
are fully enrolled, and we look forward to reporting topline
results in the fourth quarter of 2017.”
BELMONT Phase 2 Study Design
BELMONT was a Phase 2, randomized, double-blind, dose-ranging,
active comparator and placebo-controlled, multi-center study
conducted at key sites in Canada. The study evaluated the safety,
efficacy and duration of three doses of RT002 (RTT150 (Botulinum
Toxin Type A) for Injection, 20U, 40U or 60U), compared to the
labeled dose of the current market leader BOTOX Cosmetic 20U (or
VISTABEL as trademarked in Canada) and a placebo control in
treating glabellar lines. The BELMONT study enrolled 268 subjects
with moderate to severe glabellar lines during maximum frown. The
primary efficacy measurements for the study were the investigator’s
assessment of glabellar line severity at maximum frown (IGA-FWS)
and median duration of effect from the date of treatment to when a
subject reverts to baseline severity. Subjects in the BELMONT study
were randomized equally across five study groups receiving one of
three doses of RT002, the active comparator or placebo. The trial
followed subjects for up to 36 weeks or until they returned to
baseline.
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.
*BOTOX® and VISTABEL® are registered trademarks 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 May 9, 2017. 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/20170615005381/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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