- Topline Results Expected in 2017 -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today announced initiation of a Phase
2 placebo-controlled trial of its investigational drug candidate
DaxibotulinumtoxinA for Injection (RT002) for the management of
plantar fasciitis. This painful affliction, caused by inflammation
of the ligament running along the bottom of the foot, is the most
common cause of heel pain. Topline clinical results from the Phase
2 trial are expected in 2017.
“The plantar fascia is the foot’s shock absorber. Repeated
pressure on this tissue, whether from sport activities, aging, or
obesity, can create small tears in or overstretch the fascia. The
result is inflammation accompanied by sharp, constant pain that
often gets worse over time and can become highly debilitating,"
said Clinical Investigator L. Andrew Koman, MD, Professor and Chair
of the Department of Orthopaedic Surgery and Executive Director
Musculoskeletal Service Line, Wake Forest School of Medicine.
“Preclinical and clinical research suggests a neurotoxin candidate
such as RT002 may provide patients with sustained relief from
chronic heel pain and support healing of the plantar fascia without
the risks of plantar fascia rupture or atrophy of the fat pad that
can occur with corticosteroid injections.1”
An estimated one in 10 people will develop plantar fasciitis
during their lifetime. Symptoms can last six months or more,
sometimes requiring surgery.2 In the United States alone, more than
two million patients undergo treatment for plantar fasciitis each
year.3
“This Phase 2 study for plantar fasciitis will advance a whole
new treatment area for botulinum toxin that addresses pain and
muscle tightness. Revance has the opportunity to be a first mover
for this indication and other musculoskeletal disorders,” said Dan
Browne, President and Chief Executive Officer at Revance. “No
botulinum toxin is approved for treating plantar fasciitis;
however, the clinical endpoints are well validated. Published
estimates place the annual U.S. evaluation and treatment market for
plantar fasciitis at more than $250 million, and we believe the
market could grow significantly larger if patients had a compelling
neurotoxin treatment option.”
Phase 2 Study Design
This Phase 2 prospective, randomized, double-blinded,
placebo-controlled 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. The study is expected to enroll
approximately 60 subjects in the United States. The study’s primary
efficacy endpoint is the improvement in the American Orthopaedic
Foot and Ankle Score (AOFAS). 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.4 Plantar fasciitis is estimated to affect 10 to
18 million individuals in the United States annually.3 Risk factors
include age, long distance running, excessive weight, abnormal foot
posture, use of poor foot wear, and repetitive trauma.5
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.6
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 and
neurology. Revance’s science is based upon a proprietary TransMTS®
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, and has the potential to be the first
long-acting neurotoxin. The company holds worldwide rights for all
indications of RT002 injectable and RT001 topical and the
pharmaceutical uses of the TransMTS technology platform. More
information on Revance may be found at www.revance.com.
"Revance Therapeutics", TransMTS®, "Remarkable Science Changes
Everything", and the Revance logo are registered trademarks
of Revance Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to: statements about our business
strategy, our investigational drug product candidates, expected
efficacy of our drug product candidates, clinical development,
timeline and other goals and market for our anticipated products,
plans and prospects and statements about 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 on August 5, 2016. These forward-looking statements
speak only as of the date hereof. Revance disclaims any obligation
to update these forward-looking statements.
References:
1. JAAPA. 2012 Nov;25(11):48-53.
2. J Res Med Sci. 2012 Aug;17(8):799–804.
3. Foot & Ankle Int. 2004;25(5):303-310.
4. Med Clin N America. 2014;98(2): 339-352.
5. Foot & Ankle Int. 2008 Mar; 29(3):358-366.
6. J Am Acad Orthop Surg. 2014;22(6):372-380.
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version on businesswire.com: http://www.businesswire.com/news/home/20161103005182/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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