- Data to be presented at 21st International
Congress of Parkinson’s Disease and Movement Disorders, June 5-8,
2017 -
- 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 treating
aesthetic and therapeutic conditions, today announced duration of
effect of at least 24 weeks in its U.S. Phase 2 open-label,
dose-escalating clinical study of DaxibotulinumtoxinA Injectable
(RT002) to treat moderate-to-severe isolated cervical dystonia, a
movement disorder of the neck, in adults. The company also
announced additional positive efficacy results and that RT002 was
generally safe and well-tolerated.
TOP-LINE 24-WEEK RESULTS
• DURATION OF EFFECT AT LEAST 24 WEEKS: The median
duration of effect was at least 24 weeks for each of the three dose
cohorts studied. Duration of effect was defined as the number of
weeks from treatment until the return of signs and symptoms that
warrant retreatment, based on subjects reaching their target
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score.
For reference, current treatment of cervical dystonia calls for
injection of botulinum toxin approximately every 3 months (12
weeks), or 4 times per year.
• POSITIVE EFFICACY RESULTS: The trial’s 4-week primary
efficacy measurement was the improvement in signs and symptoms of
cervical dystonia as determined by reduction of the TWSTRS-Total
score from baseline. At Week 4, RT002 injectable showed a
clinically significant mean reduction of 38% from baseline across
all three cohorts. This reduction continued to increase to 50% at
Week 6 for all subjects, was 42% at Week 12 and was maintained at
or above 30% 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% to 26% at Week 4 and 13% to 16% at Week 12.
On the key secondary endpoint, percentage of responders showing
improvement on Clinician Global Impression of Change (CGIC), 97% of
all subjects experienced an improvement in cervical dystonia
symptoms at Week 4.
• GENERALLY SAFE AND WELL-TOLERATED: 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%), of which all cases were mild in
severity, injection site redness (8%), injection site bruising
(5%), injection site pain (5%), muscle tightness (5%) and muscle
weakness (5%). For reference, trials for botulinum toxin type A
products approved to treat cervical dystonia have adverse events
for dysphagia ranging from 13% to 39%.
Based on these Phase 2 results, the company expects to discuss
next steps in this clinical program with the US and EU regulatory
agencies later this year.
“Patients with cervical dystonia suffer from considerable pain
and debilitation, which dramatically impacts their quality of life.
Nearly all subjects in this study responded to treatment and a
majority were still responding to RT002 at 24 weeks. These results
represent the potential for a meaningful advancement in the
treatment of cervical dystonia,” said Roman Rubio, MD, Senior Vice
President of Clinical Development at Revance. “Cervical dystonia
patients often request neurotoxin retreatment as early as 10 weeks
and RT002 may provide patients with prolonged relief of the signs
and symptoms associated with cervical dystonia.”
Dan Browne, President and Chief Executive Officer at Revance
added, “RT002 injectable sets a new standard in cervical dystonia
clinical trial results. RT002 achieved long-lasting relief with
fast onset of action, high response rates and sustained efficacy in
treating this chronic neurological disorder. RT002 has potential to
manage this debilitating disease with at most two treatments per
year, which matters to patients, physicians and payors alike.”
Late-Breaking Abstract at 21st International Congress of
Parkinson’s Disease and Movement Disorders
The abstract for this Phase 2 clinical trial of RT002 injectable
to treat cervical dystonia was submitted to the 21st International
Congress of Parkinson’s Disease and Movement Disorders and has been
accepted for a late-breaking abstract poster presentation on
Wednesday, June 7, 2017 at 1:15 pm PT in Vancouver, Canada. Study
investigator Cynthia L. Comella, MD, Professor in the Department of
Neurological Sciences at Rush University Medical Center, Chicago,
Illinois, is scheduled to present. The results will also be
presented at the regular session poster with guided tour on
Thursday, June 8 at 1:15 pm PT by study investigator Atul Patel,
MD, MHSA, Physical Medicine and Rehabilitation Physician at Kansas
City Bone & Joint.
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, May 18, 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: 25791044; 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 24-week 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 May 18, 2017 at
4:30 pm PT/7:30 pm ET through 7:30 pm ET on May 19, 2017. To access
the replay, dial (855) 859-2056 or (404) 537-3406 and reference
conference ID: 25791044. The webcast will be available in the
investor relations section on the Company's website for 30 days
following the completion of the call.
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 moderate-to-severe cervical dystonia were enrolled at
multiple sites in the United States. 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 of 13 subjects received from
300 to 450 units.
The primary efficacy endpoint of the Phase 2 study was 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 validated 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
pain associated with the condition. The study protocol also feature
a number of secondary efficacy endpoints.
All subjects were followed until they returned to baseline or
for up to a total of 24 weeks after treatment. Due to the long
duration of effect seen in the first cohort, subjects in the second
and third cohorts were given the option to continue. Several
patients elected to remain in the study and will be followed for up
to 36 weeks.
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, whose
mission is to advance research, promote awareness and education,
and support the needs of 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 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 neuromodulator. The company
holds worldwide rights for all indications of RT002 injectable and
RT001 topical and the pharmaceutical uses of its proprietary
peptide technology platform. 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 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, 2017. 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/20170518006294/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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