Revance Therapeutics (Nasdaq: RVNC), a biotechnology company
focused on innovative aesthetic and therapeutic offerings, today
announced the company will present an ePoster at the 2021 American
Academy of Neurology (AAN) Virtual Annual Meeting taking place from
April 17-22, 2021. Revance will present results from its ASPEN-1
Phase 3 clinical trial evaluating the efficacy and safety of
DaxibotulinumtoxinA for Injection for the treatment of cervical
dystonia in adults.
“We’re pleased to present the efficacy and safety findings from
the ASPEN-1 Phase 3 clinical trial evaluating DaxibotulinumtoxinA
for Injection at this year’s 2021 AAN Virtual Meeting,
specifically, the median duration of effect of up to 24 weeks, as
determined by time to loss of 80% peak treatment benefit, suggested
that DaxibotulinumtoxinA for Injection has the potential to reduce
frequency of cervical dystonia treatments by up to 50% annually,
while being generally safe and well tolerated,” said Roman Rubio,
Senior Vice President of Clinical Development at Revance. “The
findings being presented are part of a growing body of clinical
evidence that supports DaxibotulinumtoxinA for Injection’s
differentiated performance profile and underscores the potential of
our therapeutics pipeline for the treatment of muscle movement and
pain disorders for patients who suffer from these debilitating
conditions.”
The abstracts are available online via the AAN website at
www.aan.com.
ePoster Presentation:
- Title: A Phase 3 Trial Evaluating the Efficacy, Duration
of Effect, and Safety of DaxibotulinumtoxinA for Injection in the
Treatment of Cervical Dystonia Authors and Affiliations:
Joseph Jankovic, Parkinson's Disease Center and Movement Disorders
Clinic, Department of Neurology, Baylor College of Medicine,
Houston, TX; Cynthia Comella, Rush University Medical Center,
Chicago, IL; Robert A. Hauser, Director of the University of South
Florida Parkinson’s Disease and Movement Disorders Center, Tampa,
FL; Atul T. Patel, Kansas City Bone & Joint Clinic, Overland
Park, KS; Todd M. Gross, Roman G. Rubio, Domenico Vitarella,
Revance Therapeutics, Newark, CA
ASPEN Phase 3 Clinical Program in Cervical Dystonia
In 2017, the U.S. Food and Drug Administration (FDA) granted
orphan drug designation for DaxibotulinumtoxinA for Injection to
treat cervical dystonia, which provides certain developmental and
financial benefits to trial sponsors.
The company’s ASPEN Phase 3 clinical program consists of two
trials to evaluate the safety and efficacy of DaxibotulinumtoxinA
for Injection for the treatment of cervical dystonia in adults: 1)
ASPEN-1, a randomized, double-blind, placebo-controlled, parallel
group trial and 2) ASPEN-OLS, an open-label, long-term safety
trial.
Randomized Trial (ASPEN-1):
Patients were randomized to a single treatment of either 125 Unit
or 250 Unit dose of DaxibotulinumtoxinA for Injection, or placebo.
Post-treatment, patients are followed for a maximum of 36 weeks.
The primary efficacy endpoint of the trial was the mean change from
baseline in the TWSTRS Total Score at the average of Weeks 4 and 6.
Key secondary endpoints include the duration of treatment effect,
measurement of treatment response on the Clinical and Patient
Global Impression of Change assessments, and adverse events.
Further, the trial featured exploratory efficacy assessments
including the Cervical Dystonia Impact Profile (CDIP-58), a
disease-specific, patient-rated questionnaire that measures quality
of life.
Open-Label Study (ASPEN-OLS):
Patients receive up to four sequential treatment cycles of
DaxibotulinumtoxinA for Injection over the 52-week observation
period. Primary endpoints of the trial are safety and
immunogenicity after multiple cycles of treatment with
DaxibotulinumtoxinA for Injection. Key secondary endpoints are the
change from baseline in TWSTRS Total Score and the duration of
treatment effect, as well as overall treatment response based on
the Clinical and Patient Global Impression of Change. The ASPEN-OLS
trial is fully enrolled with a total of 354 patients at sites
located in the United States, Canada, and Europe.
Additional information about the ASPEN Phase 3 program is
available at www.clinicaltrials.gov.
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, cervical
dystonia is a painful and disabling chronic condition in which the
neck muscles contract involuntarily, causing abnormal movements and
awkward posture of the head and neck. The movements may be
sustained (tonic), jerky (clonic), or a combination. Cervical
dystonia (also referred to as spasmodic torticollis) may be primary
(meaning that it is the only apparent neurological disorder, with
or without a family history) or may be the result of secondary
causes (such as physical trauma).
First-line treatment for cervical dystonia is usually
neuromodulator (botulinum toxin) injections, but additional
treatments can include oral medications, surgery, and complementary
therapies. Neuromodulators block the communication between the
nerve and the muscle, relaxing the muscle, which alleviates
abnormal involuntary movements and postures. Current neuromodulator
treatments for cervical dystonia have a duration of effect of
approximately three months. Cervical dystonia can occur at any age,
although most individuals first experience symptoms in middle age.
The condition affects a few hundred thousand adults and children in
the United States alone. The global market opportunity for cervical
dystonia was $390 million in 2020 and is expected to grow to $587
million by 2025.1 According to the Decision Resources Group, the
global market for treating cervical dystonia and spasticity muscle
movement disorders was approximately $1.0 billion in 2020.1
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. is a biotechnology company focused on
innovative aesthetic and therapeutic offerings, including its
next-generation neuromodulator product, DaxibotulinumtoxinA for
Injection. DaxibotulinumtoxinA for Injection 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
DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is
pursuing U.S. regulatory approval. Revance is also evaluating
DaxibotulinumtoxinA for Injection in the full upper face, including
glabellar lines, forehead lines and crow's feet, as well as in two
therapeutic indications - cervical dystonia and adult upper limb
spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance
owns a unique portfolio of premium products and services for U.S.
aesthetics practices, including the exclusive U.S. distribution
rights to the RHA® Collection of dermal fillers, the first and only
range of FDA-approved fillers for correction of dynamic facial
wrinkles and folds, and the HintMD fintech platform, which includes
integrated smart payment, subscription and loyalty digital
services. Revance has also partnered with Viatris (formerly Mylan
N.V.) to develop 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. Resilient Hyaluronic Acid®
and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered
trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to development of a
biosimilar to BOTOX®; statements about our business strategy, the
market for our anticipated products and plans and prospects, and
potential benefits of our drug product candidates, including with
respect to cervical dystonia and muscle movement and pain
disorders, constitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. You should not
rely upon forward-looking statements as predictions of future
events. Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
the future results, levels of activity, performance, events,
circumstances or achievements reflected in the forward-looking
statements will ever be achieved or occur.
Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from our expectations. These risks and uncertainties relate, but
are not limited to: the results, timing, costs, and completion of
our research and development activities and regulatory approvals,
including delays in the approval of our BLA for DaxibotulinumtoxinA
for Injection for the treatment of glabellar lines; the impact of
the COVID-19 pandemic on our manufacturing operations, supply
chain, end user demand for our products, commercialization efforts,
business operations, clinical trials and other aspects of our
business; our ability to manufacture supplies for our product
candidates; the uncertain clinical development process; the risk
that clinical trials may not have an effective design or generate
positive results; the applicability of clinical study results to
actual outcomes; our ability to successfully compete with other
treatments and therapies; our ability to achieve, and the rate and
degree of commercial acceptance and the market, size and growth
potential of our drug product candidates, if approved; our ability
to successfully commercialize our drug product candidates, if
approved, and the timing and cost of commercialization activities;
our ability to obtain and maintain regulatory approval of our drug
product candidates; unanticipated costs or delays in research,
development, and commercialization efforts; our ability to develop
sales and marketing capabilities; the status of commercial
collaborations; our ability to obtain funding for our operations;
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 our periodic filings with the Securities and Exchange
Commission (SEC), including factors described in the section
entitled "Risks Factors" on our Form 10-K filed with the SEC on
February 25, 2021. The forward-looking statements in this press
release speak only as of the date hereof. We disclaim any
obligation to update these forward-looking statements.
1 December 2020 - Decision Resources Group Therapeutic Botulinum
Toxin Market Analysis Global 2021
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version on businesswire.com: https://www.businesswire.com/news/home/20210401005015/en/
Investors Revance Therapeutics, Inc.: Jessica Serra,
626-589-1007 jessica.serra@revance.com or Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620 laurence@gilmartinir.com Media
Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com or General Media: Goodfuse: Jenifer Slaw,
347-971-0906 jenifer.slaw@Goodfuse.com or Trade Media:
Nadine Tosk, 504-453-8344 nadinepr@gmail.com
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