Revance to Present Clinical Data Highlighting the Efficacy and Safety of DAXI at the ASDS 2019 Annual Meeting
October 23 2019 - 8:00AM
Business Wire
- Revance’s long-acting neuromodulator DAXI
will be featured in three abstracts and three oral presentations at
the American Society for Dermatologic Surgery (ASDS) 2019 Annual
Meeting in Chicago -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company pioneering new innovations in neuromodulators for aesthetic
and therapeutic indications, today announced three oral
presentations at the American Society for Dermatologic Surgery
(ASDS) 2019 Annual Meeting to be held in Chicago, October 24-27,
2019. Presented data will showcase Revance’s investigational
product DaxibotulinumtoxinA for Injection (DAXI), a novel botulinum
toxin type A in clinical development for the treatment of moderate
and severe glabellar lines.
“We are excited to present results from our SAKURA program, the
largest Phase 3 clinical development program to date,” said Roman
Rubio, Senior Vice President of Clinical Development at Revance.
“Patient experiences with neuromodulators have remained largely
unchanged since botulinum toxin type A treatments were introduced
30 years ago. At ASDS, we are presenting data that sets new
standards in injectable facial aesthetics and advances our mission
of transforming the patient experience.”
In one oral presentation, a pooled analysis of the two SAKURA 1
and 2 pivotal studies and the SAKURA 3 open label safety study
showed that the magnitude and duration of clinical efficacy of DAXI
between those subjects with prior botulinum toxin A (BoNT-A)
treatment and those who were treatment naïve are similar, as was
the safety profile. This suggests that a subject’s previous
experience with BoNT-A does not impact investigator assessment or
bias subjects in their ability to appropriately assess their
response to treatment in a clinical trial environment.
“I think it is quite interesting to note the results from the
pooled analyses, as they illustrate that previous BoNT-A treatment
may not be a factor in the clinical efficacy or duration of effect
of DaxibotulinumtoxinA for Injection,” said lead author Joel L.
Cohen, MD of AboutSkin Dermatology in Colorado. “These data give me
confidence that DAXI will be an appropriate, effective and
predictable treatment option for patients who may switch from
another BoNT-A product, as well as those that are new to
neuromodulators.”
Additional data being unveiled from the SAKURA 3 open-label
safety study in an oral presentation showcase the finding that a
clinically measurable improvement (≥1 grade change) in glabellar
lines was observed in over 96% of patients at week four after
treatment with DAXI, and that this result was sustained for at
least 28 weeks (~7 months) in at least half of the patients.
The third oral presentation highlights the safety and efficacy
findings from the SAKURA 3 study with DAXI for glabellar lines in
which over 2,600 patients were treated. This study showed that the
clinical responses to DAXI for both response rates and duration of
effect were highly consistent from treatment cycle to treatment
cycle and no new safety concerns were observed.
Revance’s scheduled presentations are:
Podium Presentations
- DaxibotulinumtoxinA for injection is similarly effective in
experienced BoNT patients and in those naïve to treatment. Friday,
Oct 25 from 3:15-3:20pm during the 1:30-3:30pm Oral Abstracts:
Cosmetic Dermatologic Surgery session. Presenter: Joel L. Cohen,
Dermatologist at AboutSkin Dermatology and DermSurgery PC,
Greenwood Village, CO.
- Results of a large open label safety study of
DaxibotulinumtoxinA for Injection in Glabellar Lines. Saturday, Oct
26 from 1:47-1:50 pm during the 1:45-2:45 pm Cosmetic Abstract
session. Presenter: Dr. Sabrina Guillen-Fabi, Dermatologist and
Associate at Cosmetic Laser Dermatology, San Diego, Volunteer
Assistant Clinical Professor, University of California San Diego,
CA, USA.
- Clinically Measurable Improvement in Glabellar Lines Wrinkle
Severity from Three Phase 3 Studies of DaxibotulinumtoxinA for
Injection. Thursday, Oct 24 from 2:08-2:10pm during the 1:30-2:25pm
Oral Abstracts session. Presenter: Kavita Mariwalla, Dermatologist
at Mariwalla Dermatology, West Islip, NY, USA.
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 RT002, 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 RT002 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191023005264/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
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Apr 2023 to Apr 2024
