- Topline Results 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
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
"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
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
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
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
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.
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
1. JAAPA. 2012 Nov;25(11):48-53.
2. J Res
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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