Revance Announces Initiation of Phase 2 Trial of RT002 Injectable to Treat Plantar Fasciitis

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.