Market Overview

Revance Reports Additional Positive Week 24 Efficacy Results from RT002 Injectable Phase 2 Cervical Dystonia Trial


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.


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.

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.

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

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

"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!