Revance Completes Patient Enrollment in Phase 2 Program for RT002 Injectable in the Management of Plantar
Fasciitis
- Company expects to report topline eight-week results at the end of the year -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in treating
aesthetic and therapeutic conditions, today announced it has completed enrollment of patients in the Company’s Phase 2 program
investigating the use of DaxibotulinumtoxinA for Injection (RT002) for the management of plantar fasciitis. The study enrolled 59
subjects across five centers in the United States (US). The Company remains on track to report 8-week topline results at the end of
this year, including the primary and secondary endpoints, along with safety data.
“One in 10 people will develop plantar fasciitis pain in their lifetime and more than two million patients in the US undergo
treatment annually. No neuromodulator has been approved for the treatment of this debilitating pain indication and current
treatments do not provide fast, sustained pain relief,” said Dan Browne, President and Chief Executive Officer at Revance. “RT002
is unlike any other neuromodulator, with potential to provide improved outcomes and patient experience over existing treatments. We
are eager to report topline data for plantar fasciitis before year end.”
Phase 2 Study Design
This Phase 2 prospective, randomized, double-blind, placebo-controlled, multi-center study conducted at five centers in the US
is evaluating 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’s primary efficacy endpoint is the
reduction in the visual analog scale (VAS) for pain in the foot evaluated at Week 8. Improvement in the American Orthopaedic Foot
and Ankle Score (AOFAS) is one of several secondary endpoints. Subjects will be followed for a total of 16 weeks post
treatment.
About Plantar Fasciitis
Heel pain is the most common complaint of patients who visit podiatrists and orthopaedic foot and ankle surgeons. Eighty percent
of reported heel pain complaints are due to plantar fasciitis, which is caused by tears in the facia that in turn lead to
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 quarterly report on Form 10-Q filed August 4, 2017. These forward-looking statements speak only as of the date hereof. Revance
disclaims any obligation to update these forward-looking statements.
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References:
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| 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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Investors:
Revance Therapeutics, Inc.:
Jeanie Herbert, 714-325-3584
jherbert@revance.com
or
Burns McClellan, Inc.:
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Trade Media, Inc.:
For Revance Therapeutics, Inc.:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com
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