- DaxibotulinumtoxinA for Injection (DAXI) has
potential to be first long-acting neuromodulator for treatment of
this debilitating involuntary muscle movement disorder -
- Topline data expected in second half of 2020
-
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company pioneering new innovations in neuromodulators for aesthetic
and therapeutic indications, today announced it has completed
patient enrollment of the company’s pivotal ASPEN-1 Phase 3
clinical trial for its investigational drug candidate
DaxibotulinumtoxinA for Injection (DAXI) for the treatment of
isolated cervical dystonia (CD), a movement disorder affecting the
neck. In total, 301 adult patients were enrolled at 60 sites across
the U.S., Canada and Europe.
“The completion of patient enrollment in the ASPEN-1 trial marks
an important milestone in our development efforts for DAXI and
represents the first of many therapeutic indications we plan to
pursue for our novel, long-acting neuromodulator,” said Mark Foley,
President and Chief Executive Officer at Revance. “While our
initial regulatory approval for DAXI, expected in 2020, is for the
aesthetic indication of glabellar lines, DAXI promises to be a
meaningful advancement in the treatment of cervical dystonia,
potentially providing a significantly prolonged improvement of
symptoms in patients with only twice-a-year administration.”
Symptom-relieving treatments for cervical dystonia vary and are
often used in combination. These include physical therapy, muscle
relaxants and neuromodulator injections. Currently approved
neuromodulator formulations only provide relief for about 10-14
weeks.
“Sustained relief is rare with currently-approved treatments for
cervical dystonia, and a longer-lasting response would make a
significant difference for patients,” said Roman Rubio, M.D.,
Senior Vice President of Clinical Development at Revance. “In our
Phase 2 study, treatment with DAXI resulted in clinically
meaningful relief from the pain and disability experienced by
patients with cervical dystonia for a median duration of 24
weeks.”
Revance plans to announce topline results from the ASPEN-1 Phase
3 trial in the second half of 2020, and is currently enrolling
patients in a Phase 2 trial for adult upper limb spasticity and a
Phase 2 trial for plantar fasciitis.
DAXI is an investigational product and not approved by the
FDA.
ASPEN Phase 3 Clinical Program in Cervical Dystonia
The company’s ASPEN Phase 3 clinical program consists of two
trials to evaluate the safety and efficacy of DaxibotulinumtoxinA
for Injection (DAXI) 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.
Pivotal Trial (ASPEN-1): Patients
were randomized to either a low dose or high dose of DAXI, or
placebo treatment. Post-treatment, patients are followed for a
maximum of 36 weeks. The primary efficacy endpoint of the trial is
the change from baseline in the Toronto Western Spasmodic
Torticollis Rating Scale (TWSTRS) - total score. Key secondary
endpoints include the duration of treatment effect, the Clinical
and Patient Global Impression of Change, and adverse events.
Further, the trial features exploratory efficacy assessments
including the Cervical Dystonia Impact Profile (CDIP-58), a
disease-specific, patient-rated questionnaire that measures quality
of life.
Open-Label Trial (ASPEN-OLS):
Patients receive up to four continuous treatment cycles of DAXI
over the 52-week observation period. Primary endpoints of the trial
are safety and immunogenicity after multiple cycles of treatment
with DAXI. 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. A significant number of patients from
the randomized pivotal trial are expected to roll over into the
open-label trial, which has plans to enroll a total of 350 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 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 results of secondary causes (such as physical
trauma).
Treatments for cervical dystonia include oral medications,
neuromodulator (botulinum toxin) injections, 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 10-14 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. Global Industry Analysts, Inc. estimates
the global market for treating muscle movement disorders with
botulinum toxins, including cervical dystonia, was approximately
$1.1 billion in 2018.
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 Revance Therapeutics' 2019
financial outlook, expected cash runway and other financial
performance; the process and timing of, and ability to complete,
current and anticipated future clinical development of our
investigational drug product candidates; the initiation, design,
enrollment, submission, timing and results of our clinical studies,
including the near-term milestone expectations described above;
development of a biosimilar to BOTOX®; results of our non-clinical
programs; statements about our business strategy, timeline and
other goals and market for our anticipated products, plans and
prospects, including our pre-commercialization plans and timing of
our anticipated BLA submission to treat glabellar (frown) lines and
potential regulatory approach and product launch; statements about
our ability to obtain, and the timing relating to, regulatory
approval with respect to our drug product candidates; and potential
benefits of our drug product candidates and our excipient peptide
and other 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 November 4,
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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INVESTORS Revance Therapeutics, Inc.: Jeanie Herbert,
714-325-3584 jherbert@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: Y&R: Jenifer Slaw,
347-971-0906 jenifer.slaw@YR.com or Trade Media: Nadine Tosk,
504-453-8344 nadinepr@gmail.com
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