Revance Announces Publication of SAKURA 1 and SAKURA 2 Results in Plastic and Reconstructive Surgery
November 04 2019 - 8:00AM
Business Wire
- Results show DaxibotulinumtoxinA for
Injection (DAXI) can reduce frown lines for 24 weeks (approximately
6 months) or more -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company pioneering new innovations in neuromodulators for aesthetic
and therapeutic indications, today announced the publication of
results from the Phase 3 studies, SAKURA 1 and SAKURA 2, in Plastic
and Reconstructive Surgery (PRS), the peer reviewed Journal of the
American Society of Plastic Surgeons. These two Phase 3 studies
evaluated Revance’s long-acting neuromodulator product,
DaxibotulinumtoxinA for Injection (DAXI), for the treatment of
moderate and severe glabellar lines.
This manuscript presents the findings from SAKURA 1 and 2
side-by-side, which demonstrate the consistency of efficacy and
safety results evident between the two pivotal studies, as well as
the reproducibility of these outcomes with DAXI across patients and
clinical trial sites.
Both SAKURA 1 and SAKURA 2 demonstrated that half of the
patients treated maintained none or only mild frown lines for at
least 24 weeks (approximately 6 months), after a single treatment.
Additionally, frown lines did not return to their pre-treatment
severity for at least 26–28 weeks for half of the patients
treated.
“The publication in PRS highlights the quality of the Phase 3
clinical data and underscores how DAXI unlocks the true potential
for a next generation neuromodulator product,” said Mark Foley,
President and Chief Executive Officer of Revance Therapeutics,
Inc.
SAKURA 1 and SAKURA 2 were identically designed studies,
conducted to evaluate consistency of results. Both trials
demonstrate that DAXI may offer a prolonged duration of none or
mild response (median ≥ 24 weeks) and is generally well tolerated.
The most common side effects that developed in response to
treatment were headache (5.9%–7.0%), pain at the injection site
(2.4%–5.0%) and drooping of the eyelid (eyelid ptosis;
2.0%–2.5%).
“The SAKURA program is the largest ever botulinum toxin type A
clinical trial program in subjects with moderate or severe
glabellar lines. These data demonstrated a clinically meaningful
benefit with a median duration of more than 24 weeks,” said lead
author Jean D. Carruthers, MD, who has served as an investigator
for multiple FDA-approved neuromodulators and is a clinical
professor at the University of British Columbia. “The prolonged
duration of clinical benefit with DAXI can help sustain efficacy
between treatments and lessen the frequency of re-treatment, which
could significantly improve patient satisfaction. DAXI may very
well change patients’ expectations for a neuromodulator
treatment.”
Additional results from the Phase 3 studies, SAKURA 1, 2, and 3,
were presented last week at the American Society for Dermatologic
Surgery 2019 (ASDS) Annual Meeting in Chicago. The full publication
can be accessed via Revance’s website under the Our Science section
or at
https://www.revance.com/clinical-information/?category=aesthetics.
About Revance Therapeutics, Inc.
Revance Therapeutics is a Silicon Valley-based biotechnology
company, pioneering new innovations in neuromodulators for
aesthetic and therapeutic indications. Revance’s lead product
candidate, DaxibotulinumtoxinA for Injection (DAXI), combines a
proprietary stabilizing peptide excipient with a highly purified
botulinum toxin that does not contain human or animal-based
components. Revance has successfully completed a Phase 3 program
for DAXI in glabellar (frown) lines, delivering unprecedented
efficacy and long-lasting duration of effect, and is pursuing U.S.
regulatory approval in 2020. Revance is also evaluating DAXI in
forehead lines and lateral canthal lines (crow’s feet), as well as
in three therapeutic indications - cervical dystonia, adult upper
limb spasticity and plantar fasciitis, with plans to study
migraine. Beyond DAXI, Revance has begun development of a
biosimilar to BOTOX®, which would compete in the existing
short-acting neuromodulator marketplace. Revance is dedicated to
making a difference by transforming patient experiences. For more
information or to join our team visit us at www.revance.com.
“Revance Therapeutics” 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, including the timing
and results of the SAKURA 3 study of DAXI for Injection, 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; including our
pre-commercialization plans; and statements about our ability to
obtain regulatory approval, including the timing of potential BLA
filing for DAXI for Injection to treat glabellar (frown) lines; 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 August 6, 2019.
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: https://www.businesswire.com/news/home/20191104005239/en/
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com or General Media: Y&R: Jenifer Slaw,
347-971-0906 jenifer.slaw@YR.com or Trade Media: Nadine Tosk,
504-453-8344 nadinepr@gmail.com
Investors Revance Therapeutics, Inc.: Jeanie Herbert,
714-325-3584 jherbert@revance.com or Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620 laurence@gilmartinir.com
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