- ePoster and video presentation showcasing
Phase 3 data to be shared -
Revance Therapeutics, Inc. (Nasdaq: RVNC) a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today announced that it will present an ePoster with a video poster
presentation by Dr. Joseph Jankovic at the International Parkinson
and Movement Disorder Society (MDS) Virtual Congress 2021 taking
place from September 17-22, 2021. Revance will present results from
its ASPEN-1 Phase 3 clinical trial evaluating the efficacy,
duration of effect and safety of DaxibotulinumtoxinA for Injection,
for the treatment of cervical dystonia in adults, showing a
meaningful reduction in signs and symptoms associated with cervical
dystonia.
"Data from the ASPEN-1 clinical trial continues to highlight
DaxibotulinumtoxinA for Injection’s long duration of effect and
encouraging safety profile for the treatment of cervical dystonia,
reinforcing the drug product’s differentiated performance profile,”
said Roman Rubio, Senior Vice President of Clinical Development at
Revance. "We look forward to filing a Supplemental Biologics
License Application, which may bring us one step closer to helping
patients with this debilitating condition achieve long-lasting
symptom relief."
The following ePoster and video presentation is available online
via the MDS website at MDSCongress.org.
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, Nashville, TN
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 the
following two trials to evaluate the safety and efficacy of
DaxibotulinumtoxinA for Injection for the treatment of cervical
dystonia in adults:
- Randomized Controlled 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
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 with patients experiencing symptom
re-emergence within approximately 10.5 weeks. 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 $436 million in 2021
and is expected to grow to $624 million by 2026.1 According to the
Decision Resources Group, the global market for treating cervical
dystonia and spasticity muscle movement disorders was approximately
$1.2 billion in 2021.1
About Revance
Revance 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®; the potential benefits of DaxibotulinumtoxinA
for Injection for the treatment of cervical dystonia; the
differentiated performance profile of DaxibotulinumtoxinA for
Injection; the filing of an sBLA; and statements about our
strategy, plans and prospects, 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 the continuing delay in the FDA’s approval of the BLA for
DaxibotulinumtoxinA for Injection for the treatment of glabellar
lines, including as a result of observations made by the FDA during
the site inspection or other reasons; 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 and
on the market; our ability to manufacture supplies for our product
candidates and to acquire supplies of the RHA® Collection of dermal
fillers; the uncertain clinical development process; the risk that
clinical trials may not have an effective design or generate
positive results or that positive results would assure regulatory
approval or commercial success; the applicability of clinical study
results to actual outcomes; the rate and degree of economic
benefit, the safety, efficacy, commercial acceptance and the
market, competition, size and growth potential of the RHA®
Collection of dermal fillers and our dug product candidates, if
approved; our ability to continue to successfully commercialize the
RHA® Collection of dermal fillers and fintech platform and our
ability to successfully commercialize DaxibotulinumtoxinA for
Injection, if approved, and the timing and cost of
commercialization activities; our ability to expand sales and
marketing capabilities; the status of commercial collaborations;
our ability to obtain funding for our operations; our ability to
continue obtaining and maintaining intellectual property protection
for our drug product candidates; our financial performance,
including future revenue, expenses and capital requirements; 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 and
including, without limitation, our Form 10-Q for the quarter ended
June 30, 2021, filed with the SEC on August 5, 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.
SOURCES
- Decision Resources Group Therapeutic Botulinum Toxin Market
Analysis Global 2021
- Carruthers JD, Fagien S, et al. DaxibotulinumtoxinA for
Injection for the treatment of glabellar lines: results from each
of two multicenter, randomized, double-blind, placebo-controlled,
phase 3 studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg.
2020;145(1):45-58.
- Fabi SG, Cohen JL, et al. DaxibotulinumtoxinA for Injection for
the treatment of glabellar lines: efficacy results from SAKURA 3, a
large, open-label, phase 3 safety study. Dermatol Surg. 2020.
doi:10.1097/DSS.0000000000002531
- Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical
experiences with CPP-based self-assembling peptide systems in
topical drug development. Methods Mol Biol. 2011;683:553-572.
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version on businesswire.com: https://www.businesswire.com/news/home/20210916005269/en/
Media Revance Therapeutics, Inc.: Sara J. Fahy,
949-887-4476 sfahy@revance.com
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
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