Positive BELMONT Phase 2 Trial Results Published in Dermatologic Surgery
- 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.
Investors:
Revance Therapeutics
Jeanie Herbert, 714-325-3584
jherbert@revance.com
or
Burns McClellan
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Trade Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com
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