- RT002 Injectable has potential to be first
long-acting neuromodulator for treatment of a debilitating
involuntary muscle movement disorder -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing neuromodulators for use in treating aesthetic
and therapeutic conditions, today announced initiation of patient
dosing in the company’s ASPEN Phase 3 clinical program for its
investigational drug candidate DaxibotulinumtoxinA for Injection
(RT002) for the treatment of cervical dystonia (CD), a movement
disorder of the neck.
“In our Phase 2 study, treatment with RT002 resulted in patients
realizing clinically meaningful relief from the pain and disability
associated with cervical dystonia for at least 24 weeks,” said
Roman Rubio, MD, Senior Vice President of Clinical Development at
Revance. “Current botulinum toxin injections for cervical dystonia
are administered at approximately 12-week intervals. With the
potential for twice yearly administration, RT002 could represent a
meaningful advancement in treatment, providing significantly
prolonged improvement of symptoms in patients.”
“The initiation of our pivotal program is an important milestone
for Revance as we advance our novel long-lasting neuromodulator
RT002 in this important therapeutic indication,” said Dan Browne,
President and Chief Executive Officer at Revance. “The FDA granted
Orphan Drug Designation for the use of RT002 in the treatment of
cervical dystonia, and we believe that RT002 can deliver improved
patient outcomes not only in cervical dystonia therapy, but in a
number of other muscle movement disorders as well.”
Positive results from the company’s open-label, dose-escalating
Phase 2 clinical study of RT002 injectable in the treatment of
cervical dystonia were recently published in Movement Disorders
Clinical Practice. The trial demonstrated a median duration of
effect of at least 24 weeks for each of the three dose cohorts
studied. For reference, current treatment of cervical dystonia
calls for injection of botulinum toxin approximately every three
months (12 weeks), or four times per year.
The Phase 2 trial achieved its primary efficacy endpoint,
demonstrating a clinically significant mean reduction of 38 percent
in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
- Total score from baseline at Week 4 across all three cohorts.
This mean reduction continued to increase to 50 percent at Week 6,
was 42 percent at Week 12, and was maintained at or above 30
percent through Week 24. For reference, placebo-controlled trials
for botulinum toxin type A products approved to treat cervical
dystonia had a reduction in the TWSTRS – Total score from baseline
of 21 percent to 26 percent at Week 4 and 13 percent to 16 percent
at Week 12.
Regarding the Phase 2 study’s key secondary endpoint –
percentage of responders showing improvement on Clinician Global
Impression of Change (CGIC) – 97 percent of all patients
experienced an improvement in cervical dystonia symptoms at Week 4.
In all three cohorts, RT002 injectable appeared to be generally
safe and well-tolerated through Week 24. There were no serious
adverse events and no dose-dependent increase in adverse events.
The treatment-related adverse events were generally transient and
mild to moderate in severity, with one case of neck pain reported
as severe. The most common adverse events were dysphagia, or
difficulty in swallowing (14 percent), of which all cases were mild
in severity, injection site redness (8 percent), injection site
bruising (5 percent), injection site pain (5 percent), muscle
tightness (5 percent) and muscle weakness (5 percent).
The global neuromodulator opportunity for muscle movement
disorders in 2017 was estimated to be more than $1 billion. The
company plans to initiate a Phase 2 program in upper limb
spasticity, the largest indication in the muscle movement segment,
later this year.
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 RT002 injectable for
the treatment of cervical dystonia in adults: 1) a randomized,
double-blind, placebo-controlled, parallel group trial, and 2) an
open-label, long-term safety trial. The program is expected to
enroll a total of approximately 300 patients at multiple sites in
the United States, Canada, and Europe.
Randomized Trial: Patients will be
randomized to either a low dose or high dose of RT002 injectable or
placebo treatment. Post-treatment, patients will be followed for a
maximum of 36 weeks. The primary efficacy endpoint of the trial
will be the change from baseline in the TWSTRS – Total score. Key
secondary endpoints include the duration of treatment effect, the
Clinical and Patient Global Impression of Changes, 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: Patients will
receive up to four continuous treatment cycles of RT002 injectable
over the 52-week observation period. Primary endpoints of the trial
are safety and immunogenicity after multiple cycles of treatment
with RT002. 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.
Additional information about the ASPEN Phase 3 program,
including patient eligibility criteria, will be posted shortly
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)
and can cause considerable pain and discomfort.
Treatments for cervical dystonia include oral medications,
neuromodulator (botulinum toxin) injections, surgery, and
complementary therapies. Neuromodulators blocks 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. Global Industry Analysts, Inc.
estimates the global market for treating muscle movement disorders
with botulinum toxins, including cervical dystonia, was nearly $1.1
billion in 2017.
About Revance Therapeutics, Inc.
Revance Therapeutics is a biotechnology company developing
neuromodulators for use in treating aesthetic and underserved
therapeutic conditions, including muscle movement disorders and
pain. The company's lead drug candidate, DaxibotulinumtoxinA for
Injection (RT002), is currently in development for the treatment of
glabellar lines, cervical dystonia and plantar fasciitis, with
plans to initiate studies in upper limb spasticity and chronic
migraine. RT002 has the potential to be the first long-acting
neuromodulator. Revance has developed a proprietary, stabilizing
excipient peptide technology designed to create novel,
differentiated therapies. The company has a comprehensive pipeline
based upon its peptide technology, including injectable and topical
formulations of daxibotulinumtoxinA. More information on Revance
may be found at www.revance.com.
"Revance Therapeutics" and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements related to Revance Therapeutics' long-term
financial outlook 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, including but not limited to initiation and design of
clinical studies for current and future indications, 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; and statements about our
ability to obtain regulatory approval; 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 May 9, 2018. 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/20180621006037/en/
INVESTORSRevance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.:Ami
Bavishi, 212-213-0006abavishi@burnsmc.comorMEDIATOGORUN:Mariann
Caprino, 917-242-1087m.caprino@togorun.com
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Aug 2024 to Sep 2024
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Sep 2023 to Sep 2024