Market Overview

Revance Announces Positive Top-Line 24-Week Duration of Effect Results in All Three Cohorts in RT002 Injectable Phase 2 Cervical Dystonia Trial

Share:





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.

View Comments and Join the Discussion!
 

Partner Center