Revance Provides Update on Phase 2 Program for RT002 Injectable in the Management of Plantar Fasciitis
May 01 2017 - 7:30AM
Business Wire
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in treating
aesthetic and therapeutic conditions, today announced that it is
expanding the Company’s Phase 2 program investigating the use of
DaxibotulinumtoxinA for Injection (RT002) for the management of
plantar fasciitis from a single center to a multi-center study with
protocol updates. Revance expects to report topline results from
the Phase 2 study in the fourth quarter of 2017.
“We are very excited about the potential use of RT002 to treat
plantar fasciitis, which causes severe pain and inflammation along
the bottom of the foot, especially in the heel area,” said Dan
Browne, President and Chief Executive Officer at Revance. “We have
moved from a single center to a multi-center study protocol,
including Wake Forest Baptist Medical Center and two new
non-academic study sites, to help us meet our enrollment goals and
report topline safety and efficacy results for the plantar
fasciitis program before year-end. The combination of a validated
visual analog scale (VAS) for measuring the reduction of pain in
the foot as a primary endpoint and the improvement in the American
Orthopaedic Foot and Ankle Score (AOFAS) as a secondary endpoint
provide for clinically meaningful measurements of RT002’s ability
to reduce the pain associated with plantar fasciitis. We believe
these changes strengthen the Phase 2 program’s capacity to assess
the use of RT002 to treat plantar fasciitis.”
The study protocol has been submitted to the U.S. Food and Drug
Administration and is scheduled to post on clintrials.gov this
week. Recruitment and screening of patients under the new study
protocol is already underway.
Phase 2 Study Design
This Phase 2 prospective, randomized, double-blinded,
placebo-controlled, multi-center study will evaluate the safety and
efficacy of a single administration of Revance’s investigational
drug candidate DaxibotulinumtoxinA for Injection (RT002) in
reducing the signs and symptoms of plantar fasciitis. This study is
expected to enroll approximately 60 subjects across three centers
in the United States. The study’s primary efficacy endpoint is the
reduction in the visual analog scale (VAS) for pain in the foot.
Improvement in the American Orthopaedic Foot and Ankle Score
(AOFAS) is one of several secondary endpoints. Subjects will be
followed for 16 weeks post treatment.
About Plantar Fasciitis
Heel pain is the most common complaint of patients who visit
podiatrists and orthopeadic foot and ankle surgeons. Eighty percent
of reported heel pain complaints are due to plantar fasciitis,
which is caused by inflammation of the connective tissue in the
arch of the foot.1 Plantar fasciitis is estimated to affect 10 to
18 million individuals in the United States annually.2 Risk factors
include age, long distance running, excessive weight, abnormal foot
posture, use of poor foot wear, and repetitive trauma.3
Treatment options for less severe cases include leg and foot
stretching exercises, nonsteroidal anti-inflammatory drugs, shoe
inserts, heel pads, and night splints. More severe or refractory
cases are currently treated with steroid injections, extracorporeal
shock wave therapy, platelet rich plasma injections, and/or
surgery.4
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 to 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 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 annual report on Form 10-K
filed February 28, 2017. These forward-looking statements
speak only as of the date hereof. Revance disclaims any obligation
to update these forward-looking statements.
References:
1. Med Clin N America. 2014;98(2): 339-352.2. Foot & Ankle
Int. 2004;25(5):303-310.3. Foot & Ankle Int. 2008 Mar;
29(3):358-366.4. J Am Acad Orthop Surg. 2014;22(6):372-380.
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version on businesswire.com: http://www.businesswire.com/news/home/20170501005493/en/
Investors:Revance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.:Ami
Bavishi, 212-213-0006abavishi@burnsmc.comorTrade Media, Inc.:Nadine
Tosk, 504-453-8344nadinepr@gmail.com
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