- Poster on display today to be presented
during late-breaking session on June 7, 2017, at 21st International
Congress of Parkinson’s Disease and Movement Disorders -
Revance Therapeutics, Inc. (NASDAQ: RVNC), a biotechnology
company developing botulinum toxin products for use in treating
aesthetic and therapeutic conditions, today announced additional
clinical 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, a movement disorder
of the neck, in adults. A late-breaking poster including these data
was displayed today and will be presented on Wednesday, June 7,
2017, at 1:15 pm PT in Vancouver, Canada, by study investigator
Cynthia L. Comella, MD, Professor in the Department of Neurological
Sciences at Rush University Medical Center, Chicago, Illinois.
These results are in addition to findings reported on May 18,
2017, which showed RT002 injectable to be generally safe and
well-tolerated. The previously reported findings also demonstrated
duration of effect of at least 24 weeks and that RT002 injectable
delivered clinically significant improvement in signs and symptoms
of cervical dystonia as determined by reduction of the Toronto
Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score
from baseline.
KEY NEW 24-WEEK FINDINGS
• DURATION OF EFFECT AT LEAST 24 WEEKS BY DOSE
GROUP: The study researchers analyzed efficacy results in two
dose groups: Dose Group A (N=21), individuals who received 100 to
240 units of RT002 injectable, and Dose Group B (N=16), receiving
300 to 450 units. Median duration of effect, defined as the number
of weeks subjects maintained at least 20% of the treatment benefit
achieved at Week 4 (Target TWSTRS Score), was greater than 24 weeks
for both dose groups, consistent with the ≥ 24-week duration of
effect previously reported in each of the trial’s three
pre-specified patient cohorts.
• TWSTRS-TOTAL AND SUBSCALE SCORES: RT002 injectable
showed a clinically significant mean reduction of the TWSTRS-Total
score from baseline at Week 4 – the primary efficacy endpoint – in
both Group A (37%) and Group B (39%), with the majority of this
benefit maintained through Week 24. In addition, clinically
meaningful reductions in TWSTRS-Severity, Disability and Pain
subscales were consistent and observed at all time points through
Week 24.
• RESPONSE RATES AND PATIENT-RATED QUALITY OF LIFE: A
high rate of response was observed in the study, with 94% of
subjects at Week 6 experiencing a reduction of at least 20% from
baseline in TWSTRS-Total Score, and 68% of subjects at week 24
observed to maintain this treatment benefit at Week 24. In
addition, a mean reduction of 37% from baseline in the Cervical
Dystonia Impact Profile (CDIP-58) score was observed at Week 6 for
all subjects, with the majority of this clinically meaningful
benefit maintained through Week 24.
• SAFETY FINDINGS: As previously reported, RT002
injectable appeared to be generally safe and well-tolerated through
Week 24 in all treatment groups evaluated. 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, with one case of neck pain reported as severe
(day 10 onset, duration of 2 days).
“Cervical dystonia is a movement disorder characterized by
involuntary movements of the head and neck resulting in abnormal
twisting postures of the head that is frequently associated with
pain. The treatment of choice for cervical dystonia is botulinum
toxin injections. Unfortunately, the drawback of this therapy as
currently available is that patients must typically be re-treated
at approximately 3 month intervals in order to maintain benefit,”
said trial investigator Cynthia Comella, MD, Professor of
Neurological Sciences, Rush University Medical Center. “The data
from the RT002 study indicate that this new formulation of
botulinum toxin serotype A may significantly improve symptoms of
cervical dystonia and have an impressive duration of benefit of 24
weeks, which is twice as long as the toxins currently available.
Overall, I believe RT002 holds tremendous promise to provide
cervical dystonia patients a significant and longer-lasting
improvement of their symptoms.”
Additional data at 21st International Congress of Parkinson’s
Disease and Movement Disorders
In addition to the late-breaking poster, a regular session
poster with guided tour is scheduled for Thursday, June 8, 2017, at
1:15 pm PT presented by study investigator Atul Patel, MD, MHSA,
Physical Medicine and Rehabilitation Physician at Kansas City Bone
& Joint.
Once the posters are displayed at the congress, the company
plans to add a slide presentation of the poster contents to its
website under the THERAPEUTICS tab in the section entitled
Presentations and Publications.
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.
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 evaluates severity of the
condition based on the physical findings 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 for up to a total of 24 weeks after
treatment, or until return of symptoms that warrant treatment, at
which time subjects could complete the study. 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/20170605005865/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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