- RT002 injectable appeared to be generally
safe and well-tolerated -
- RT002 injectable displayed clinically
significant impact on cervical dystonia signs and symptoms -
- Revance to host conference call at 4:30 pm ET
today -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today announced positive interim
results from its U.S. Phase 2 open-label, dose-escalating clinical
study of DaxibotulinumtoxinA Injectable (RT002) to treat
moderate-to-severe isolated cervical dystonia in adults, a movement
disorder of the neck.
The trial enrolled 37 subjects and follows three sequential
treatment cohorts for up to a total of 24 weeks after treatment for
each cohort. The trial’s first cohort of 12 subjects received a
single dose of up to 200 units of RT002 injectable, the second
cohort of 12 subjects received between 200 and 300 units, and the
third cohort received from 300 to 450 units. Later-enrolled
subjects in the second and third cohorts have yet to complete the
trial’s 24-week protocol. Today’s results are therefore
preliminary, with final results expected in the first half of
2017.
Interim Results from the Phase 2 Cervical
Dystonia trial:
- SAFETY: In all three cohorts,
RT002 injectable appeared to be generally safe and well-tolerated.
There were no serious adverse events and no dose-dependent increase
in adverse events. The treatment-related adverse events were
transient and mild to moderate in severity, except for one case of
neck pain reported as severe, with a duration of 2 days. The most
common adverse events were dysphagia, or difficulty in swallowing
(10.8%), injection site redness (8.1%), injection site pain (5.4%),
muscle tightness (5.4%) and muscle weakness (5.4%). For reference,
trials for botulinum type A products approved to treat cervical
dystonia have adverse events for dysphagia ranging from 13% to
39%.
- EFFICACY: The trial’s 4-week
primary efficacy measurement was the improvement in dystonia
symptoms as determined by reduction from baseline on the Toronto
Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score.
RT002 injectable showed a clinically significant mean reduction of
16.9 from baseline, or 38%, across all three cohorts. In cohort
one, with a mean dose of 174 units, the majority of the 44%
reduction observed in the TWSTRS-Total score at Week 4 was
preserved at Week 24, with a 33% mean reduction from baseline
observed. Clinically meaningful mean reductions in the TWSTRS
Severity, Disability and Pain subscales were consistent and
observed at all follow-up visits in the first cohort.
Later-enrolled subjects in the second and third cohorts have not
yet reached the 24-week point. For reference, placebo-controlled
trials with botulinum type A products approved to treat cervical
dystonia had a reduction in the TWSTRS-Total score from baseline of
14% to 26% at Week 4.
- DURATION OF EFFECT: Duration of
effect for this trial was defined as the number of weeks from
treatment until the return of symptoms that warrant retreatment,
based on the subject’s target TWSTRS score. The median duration of
effect was at least 24 weeks for subjects in cohort one (n=12), and
at least 16 weeks for subjects in cohort two (n=11), using the
complete 16 week follow up data. In cohort one, no subjects had
returned to baseline at Week 24 and only one subject in cohort two,
to date, has returned to baseline, which occurred at the Week 24
visit. In cohort one, RT002 achieved a median duration of at least
24 weeks based on three different assessments, including 1) the
number of weeks from treatment until a subject reaches or exceeds
their target TWSTRS-Total score, 2) improvement (score >0) on
the Clinician Global Impression of Change (CGIC), and 3)
TWSTRS-Total score return to baseline. For reference, current
treatment of cervical dystonia calls for injection of botulinum
toxin approximately every 3 months, or 4 times per year.
“Patients with cervical dystonia suffer from painful,
embarrassing twisting movements of the neck, often impairing their
ability to work, drive and perform activities of daily living,”
said lead trial investigator Dr. Joseph Jankovic, Professor of
Neurology, Distinguished Chair in Movement Disorders, Founder, The
Parkinson's Disease Center and Movement Disorders Clinic (PDCMDC)
Baylor College of Medicine, Houston, Texas. “The current treatment
of cervical dystonia calls for injection of botulinum toxin about
every 3 months, or 4 times per year, to provide patients with an
improved quality of life. The preliminary data in the Phase 2 trial
appears quite robust, showing marked improvements in symptoms and
signs. I am particularly encouraged that in this trial RT002
exhibited a safety profile at least as good as currently marketed
neurotoxins. Furthermore, with a sustained median duration of at
least 24 weeks, there is a possibility that patients will require
injections only two times a year. Although further studies are
needed, RT002 may represent a major advance in neurotoxin
technology, which should translate into more meaningful treatment
outcomes in patients with cervical dystonia.”
“Cervical dystonia is an ideal therapeutic indication for
testing the attributes of RT002 injectable,” said Dan Browne,
President and Chief Executive Officer at Revance. “We believe these
results may have broad implications for the product profile of
RT002, as we have now shown long duration in both low- and
high-dose indications for small and large muscles. And we’ve also
shown long duration of effect in two Phase 2 trials for the
treatment of glablellar lines.”
“Further, RT002 injectable, even at high doses, may deliver a
strong safety profile possibly by limiting the spread of toxin,
which could avoid life-altering adverse events such as general
muscle weakness and difficulty swallowing,” Browne continued. “We
plan to share the final safety, efficacy, and duration results in
2017 once all cohorts have completed the 24-week assessment period.
We then intend to seek regulatory advice from US and EU health
authorities to determine the next steps in this clinical
program.”
The abstract for this Phase 2 clinical trial of RT002 injectable
to treat cervical dystonia was submitted to the Toxins 2017
(January 18-21, Madrid, Spain) meeting and has been accepted for
presentation. Study investigator Cynthia L. Comella, MD, Professor
in the Department of Neurological Sciences at Rush University
Medical Center, Chicago, Illinois, is scheduled to present.
Phase 2 Study Design
Revance’s Phase 2 trial is an open-label, sequential,
dose-escalating study to evaluate the safety, preliminary efficacy
and duration of effect of a single treatment of DaxibotulinumtoxinA
Injectable (RT002) for isolated cervical dystonia. Thirty-seven
subjects with at least moderate cervical dystonia were enrolled at
multiple sites in the United States. There are three treatment
groups of 12, 12 and 13 subjects, respectively, each subject
treated with one of three dose levels of RT002 injectable.
The primary efficacy endpoint of the Phase 2 study is an
improvement in dystonia symptoms as measured by change (reduction)
from baseline in Toronto Western Spasmodic Torticollis Rating Scale
(TWSTRS) total score at four weeks. TWSTRS is a composite scale
that covers different features of the cervical dystonia condition.
The first part of the scale is based on the physical findings and
severity of dystonia, the second part rates the patient’s perceived
level of disability, and the third part rates the pain. The study
protocols also feature a number of secondary efficacy endpoints,
including duration of effect and patient-rated quality of life as
measured by change from baseline in Cervical Dystonia Impact
Profile (CDIP).
All subjects are followed out to nine weeks, after treatment.
Subjects with sustained improvement after this initial period of
nine weeks continue to be assessed for duration of efficacy and
other measures until they return to baseline or for up to a total
of 24 weeks after treatment.
Conference Call
Revance management will host a conference call and webcast today
at 4:30 pm ET. Individuals interested in listening to the
conference call today, December 12, at 1:30 pm PT/4:30 pm ET may do
so by dialing (855) 453-3827 for domestic callers, or (484)
756-4301 for international callers and reference conference ID:
37266728; or from the webcast link in the investor relations
section of the Company's website at: www.revance.com. In addition,
key data slides on the Phase 2 interim trial results will be
discussed on the conference call and are posted to Revance’s
website on the INVESTORS tab in the Presentations and Corporate
Materials section.
A replay of the call will be available beginning December 12,
2016 at 4:30 pm PT/7:30 pm ET through 7:30 pm ET on December 13,
2016. To access the replay, dial (855) 859-2056 or (404) 537-3406
and reference Conference ID: 37266728. The webcast will be
available in the investor relations section on the Company's
website for 30 days following the completion of the call.
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, whose
mission is to advance research, promote awareness and education,
and support the needs affected individuals, 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
brought about by secondary causes (such as physical trauma). It can
result in considerable pain and discomfort.
Treatments for cervical dystonia include oral medications,
botulinum toxin injections, surgery, and complementary therapies.
Botulinum toxin can help block the communication between the nerve
and the muscle and may alleviate abnormal movements and postures.
Current botulinum toxin 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. It affects several hundred thousand adults
and children in the United States alone. Revance estimates the
global market for treating muscle movement disorders with botulinum
toxins, including cervical dystonia, was nearly $1 billion in
2015.
About Revance Therapeutics, Inc.
Revance, a Silicon Valley-based biotechnology company, is
committed to the advancement of remarkable science. The company is
developing a portfolio of products for aesthetic medicine and
underserved therapeutic specialties, including dermatology,
orthopedics and neurology. Revance’s science is based upon a
proprietary TransMTS® peptide technology, which when combined with
active drug molecules, may help address current unmet needs.
Revance’s initial focus is on developing daxibotulinumtoxinA,
the company’s highly purified botulinum toxin, for a broad spectrum
of aesthetic and therapeutic indications, including facial wrinkles
and muscle movement disorders. 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 the potential to be the first
long-acting neurotoxin. The company holds worldwide rights for all
indications of RT002 injectable and RT001 topical and the
pharmaceutical uses of the TransMTS technology platform. More
information on Revance may be found at www.revance.com.
“Revance Therapeutics,” TransMTS®, “Remarkable Science Changes
Everything,” 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 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 risks that interim results are
not indicative of final results and 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, 2016. 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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version on businesswire.com: http://www.businesswire.com/news/home/20161212006130/en/
Investors:Revance TherapeuticsJeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellanAmi Bavishi,
212-213-0006abavishi@burnsmc.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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