Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing neuromodulators for use in treating aesthetic
and underserved therapeutic conditions, today announced interim
8-week Phase 2a results for its next-generation neuromodulator
DaxibotulinumtoxinA for Injection (RT002) in treating plantar
fasciitis, a common debilitating form of foot pain.
The trial’s primary endpoint, the reduction in the
patient-reported visual analog scale (VAS) for pain at Week 8,
showed a robust impact on pain, with a greater than 50% reduction
for patients treated with RT002. In the intent-to-treat population,
a mean reduction in the VAS score of 54.2% from baseline was
achieved with RT002, compared with a 42.6% reduction in the placebo
group, which upon further subgroup analysis, was driven primarily
by a strong placebo response in the control group at two of the
five study sites. While not statistically significant (p=0.39),
RT002 did outperform placebo, providing patients with considerable
pain relief. Similar numeric trends were seen in the secondary and
exploratory endpoints.
RT002 appeared to be generally safe and well-tolerated through
Week 8. The majority of adverse events in both treatment groups
were mild in severity. There were no treatment-related serious
adverse events. The most common treatment-related adverse events
for RT002 and placebo were injection site pain (10.0 percent and
10.3 percent) and muscle weakness (3.3 percent and 3.4 percent),
both respectively, all of which were classified as mild in
severity.
“This initial proof-of-concept study demonstrates that RT002 may
have a positive impact on the severe heal pain caused by plantar
fasciitis,” said Dan Browne, Co-Founder, President and Chief
Executive Officer of Revance. “The substantial reduction in the VAS
with RT002 at Week 8 is consistent with prior neuromodulator
studies in plantar fasciitis. This data provides a rich resource to
understand plantar fasciitis and how to best treat the pain
associated with this condition using a neuromodulator. We plan to
complete this study and review the full data set. Further, before
moving to a Phase 2b trial later this year as previously planned,
we now expect to conduct another Phase 2a trial with a modified
design to demonstrate the ability of RT002 to treat plantar
fasciitis.”
Phase 2a Study Design
This Phase 2a prospective, randomized, double-blind,
placebo-controlled, multi-center study conducted at five centers in
the U.S. is evaluating the safety and efficacy of a single
administration of 240 units of DaxibotulinumtoxinA for Injection
(RT002) in reducing the signs and symptoms of plantar fasciitis.
The trial enrolled a total of 59 male or female subjects, 18 to 65
years of age, with diagnosis of unilateral plantar fasciitis by
physical examination and/or ultrasonography. The study’s primary
efficacy endpoint is the reduction in the visual analog scale (VAS)
for pain in the foot evaluated at Week 8. The secondary endpoints
include American Orthopaedic Foot and Ankle Score (AOFAS), Foot and
Ankle Disability Index (FADI), and Patient Reported Outcome
Measurement Information System (PROMIS). An exploratory efficacy
evaluation is the Improvement in the Plantar Fasciitis Pain and
Disability Scale (PFPS). 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 fascia that in turn lead to
inflammation of the connective tissue in the arch of the foot.1
The fascia is a sheet or band of fibrous connective
tissue under the skin that covers a surface of underlying
tissues. Fascia surrounds each of the muscles that move
the skeleton. When the fascia is inflamed,
the condition is referred to as "fasciitis.”2
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.4
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.5
About RT002
DaxibotulinumtoxinA for Injection (RT002) is an investigational
product. It is a novel, next-generation neuromodulator in
development for the treatment of aesthetic and therapeutic
conditions, including glabellar lines, cervical dystonia and
plantar fasciitis. Created using Revance’s proprietary peptide
technology, RT002 has the potential to become the first
neuromodulator with long-acting duration of six months for the
treatment of glabellar lines. This proprietary, stabilizing
excipient peptide technology eliminates the need for human- and
animal-based components, which carry a potential risk of
transmitting pathogens.
Revance has two other active clinical programs for RT002
injectable under way. In December of 2017, Revance announced
positive SAKURA 1 and SAKURA 2 Phase 3 pivotal trials to treat
glabellar lines. With the SAKURA 3 open-label, long-term safety
study fully enrolled, the company plans to complete the safety
study in the second half of 2018 and file its biologics license
application (BLA) with the U.S. Food and Drug Administration (FDA)
in the first half of 2019. For the treatment of cervical dystonia,
the company was recently granted orphan drug designation and plans
to initiate a Phase 3 program in the second quarter of 2018.
About Revance Therapeutics, Inc.
Revance Therapeutics is a biotechnology company developing
neuromodulators for use in treating aesthetic and underserved
therapeutic conditions, including muscle movement disorders and
pain. 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. Revance has
developed a proprietary, stabilizing excipient peptide technology
designed to create novel, differentiated therapies. The company has
a comprehensive pipeline based upon its peptide technology,
including injectable and topical formulations of
daxibotulinumtoxinA. 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 to our business strategy, timeline and
other goals and market for our anticipated products, plans and
prospects; statements about our ability to obtain regulatory
approval; 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; 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 November 3, 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. Eosinophilic Fasciitis Prognosis, Treatment and Symptoms
https://www.medicinenet.com/eosinophilic_fasciitis/article.html
3. Foot & Ankle Int. 2004;25(5):303-310.
4. Foot & Ankle Int. 2008 Mar;29(3):358-366.
5. J Am Acad Orthop Surg. 2014;22(6):372-380.
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version on businesswire.com: http://www.businesswire.com/news/home/20180108005775/en/
INVESTORSRevance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.:Ami
Bavishi, 212-213-0006abavishi@burnsmc.comorMEDIAGeneral
Media:TOGORUN:Mariann Caprino,
917-242-1087m.caprino@togorun.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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