- Completes Type B Pre-BLA meeting with U.S.
FDA for glabellar lines indication and remains on track to submit
application in first half of 2019 -
- Initiates Phase 2 trials for RT002 in both
plantar fasciitis and adult upper limb spasticity -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing next-generation neuromodulators for use in
treating aesthetic and therapeutic conditions, today announced
updates on meetings with the U.S. Food and Drug Administration
(FDA), the initiation of two new Phase 2 clinical trials for
DaxibotulinumtoxinA for Injection (RT002) in therapeutic
indications, commercial collaborations, and details on certain
anticipated clinical and regulatory milestones in 2019.
“Revance is entering 2019 with tremendous momentum on multiple
fronts,” said Dan Browne, president and chief executive officer at
Revance. “We have an exciting ensemble of late-stage clinical
trials underway for our next-generation neuromodulator and are
operating a U.S.-based, commercial-scale drug substance and drug
product facility to manufacture a broad range of proprietary
neuromodulation formulations. We also have an active collaboration
for the introduction of RT002 in China and another to develop a
biosimilar to BOTOX®. Strategically, as we anticipate entering the
market with RT002 in 2020, we intend to set a new standard in
neuromodulators, focused on providing patients with the ability to
safely alleviate the appearance of frown lines with just two or
fewer treatments per year.”
REGULATORY UPDATE AND MILESTONES
In December of 2018, the company completed its pre-Biologics
Licensing Application (BLA) meeting with the FDA for its submission
of DaxibotulinumtoxinA for Injection (RT002) in the treatment of
glabellar (frown) lines. According to Browne, “With the
unprecedented SAKURA 3 Phase 3 open-label clinical program in
glabellar lines successfully concluded, we have completed all the
necessary clinical trials for our long-lasting neuromodulator RT002
and we are busy finalizing steps to submit our application to the
FDA for regulatory approval. We remain confident in our ability to
gain approval with a differentiated label and to build a meaningful
neuromodulator business based on innovation, best-in-class
performance, and improved patient outcomes.”
In February of 2018, Revance announced a collaboration and
license agreement with Mylan N.V. on a biosimilar to BOTOX®.
Revance has since performed detailed analytical (structural and
functional) characterization and comparability testing of its
product to the reference product for the Biosimilar Initial
Advisory Meeting (BIAM). In concert with Mylan, Revance submitted
its BIAM briefing package to the FDA to develop the biosimilar to
BOTOX® under a 351(k)-development pathway, and was granted a
face-to-face meeting in the first quarter of 2019.
“We have a strong conviction in our ability to create a
biosimilar to BOTOX® under the 351(k) pathway,” said Abhay Joshi,
PhD, Revance’s chief operating officer. “Pending FDA agreement on a
biosimilar development path, we expect to work with Mylan to
continue the analytical similarity program and conduct clinical
trials necessary for approval.”
RT002 INJECTABLE 2019 CLINICAL MILESTONES
“In 2019, we will have an extensive and active clinical pipeline
– a total of six programs for RT002 injectable that address over
half of the current $4 billion global neuromodulation market,” said
Browne. “In aesthetics, while we pursue a U.S. regulatory approval
in glabellar lines, we plan to initiate a study in the first
quarter for forehead lines in conjunction with treatment of the
glabellar complex, followed mid-year with a study in lateral
canthal lines, also known as crow’s feet. These trials will help
determine the injection pattern and dosage for treatment of the
upper face. In therapeutics, we have done a major expansion into
neuroscience indications. We are pleased to announce that in late
December we dosed the first patients in Phase 2 clinical trials for
RT002 in both plantar fasciitis and adult upper limb spasticity. We
now have clinical programs in three therapeutic areas actively
recruiting patients.”
ASPEN Phase 3 Program for Treatment of Cervical Dystonia
– Enrollment progressing to plan
The company initiated a Phase 3 program for patients with
cervical dystonia in the second quarter of 2018. Patients with
cervical dystonia suffer from painful, embarrassing twisting
movements of the neck, often impairing their ability to work, drive
and perform activities of daily living. The program consists of two
trials. First, a randomized, double-blind trial, with a high dose,
low dose and placebo group. Post-treatment, patients will be
followed for a maximum of 36 weeks. Second, an open-label,
long-term safety trial, with patients receiving up to four
treatment cycles of RT002 injectable over a 52-week observation
period. Each trial, conducted at multiple sites in the United
States, Canada, and Europe, is expected to enroll a total of
approximately 300 patients, with a majority of patients expected to
roll-over from the pivotal into the long-term safety trial.
Treatment using neuromodulators for cervical dystonia was estimated
in 2017 to be a $200 million global opportunity. The company
expects to complete enrollment by early 2020.
Phase 2 Trial for Treatment of Plantar Fasciitis – Trial
initiated, with first patient dosed at end of 2018
Revance has initiated patient dosing in a Phase 2 clinical trial
for RT002 for the management of plantar fasciitis. The plantar
fascia is the foot’s shock absorber. Repeated pressure on this
tissue, whether from sport activities, aging, or obesity, can
result in plantar fasciitis, characterized by inflammation
accompanied by sharp, constant pain in the heel that can become
highly debilitating. There are currently no FDA-approved drugs to
treat plantar fasciitis. Estimates suggest that 20 million people
suffer from plantar fasciitis in the U.S. annually and more than
two million patients per year receive treatment. Revance expects to
complete enrollment in this Phase 2 trial during the second half of
2019.
Trial Design - The Phase 2
prospective, randomized, double-blind, multi-center,
placebo-controlled study will evaluate the safety and efficacy of
two doses of 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 150 adult patients with unilateral plantar
fasciitis, from approximately 20 study centers in the United
States. Patients will be randomized (1:1:1) to receive an injection
of a low dose, high dose or placebo. The study’s primary efficacy
endpoint is the change from baseline in Numeric Pain Rating Scale
(NPRS) score at Week 8. Patients will be followed for up to 24
weeks post treatment to assess treatment response, tolerability and
safety.
Additional information, including patient
eligibility criteria, will be posted shortly at
www.clinicaltrials.gov.
JUNIPER Phase 2 Trial for Treatment of Adult Upper Limb
Spasticity–Trial now underway, with first patient dosed in late
December 2018
Today, Revance announced it dosed the first patient in the
JUNIPER Phase 2 clinical trial for RT002 in the treatment of upper
limb spasticity. Upper limb spasticity is a form of movement
disorder that presents as increased tone or stiffness of the
muscles affecting a patient’s ability to produce or control
voluntary movement in the arms and hands. Treatment using
neuromodulators for upper limb spasticity was estimated in 2017 to
be more than a $200 million global opportunity, with the muscle
movement market exceeding $1 billion globally. The company expects
to complete enrollment in the second half of 2019.
Trial Design - The company’s JUNIPER
Phase 2 clinical trial of upper limb spasticity is a randomized,
double-blind, placebo-controlled trial to evaluate the efficacy and
safety of RT002 injectable at three dose levels versus placebo in
reducing muscle tone of adult patients with upper limb spasticity
due to stroke or traumatic brain injury over 36 weeks. The program
is expected to enroll a total of approximately 128 patients, 18-70
years of age, at 25 sites in the United States.
Patients will be randomized to one of three
active treatment groups of RT002 or placebo. Post-treatment,
patients will be followed for a maximum of 36 weeks. The co-primary
efficacy endpoints of the trial will be the mean change from
baseline in muscle tone using the Modified Ashworth Score (MAS)
scale in the suprahypertonic muscle group (SMG – highest degree for
muscle tone) of the elbow, wrist, or finger flexors at Week 6, and
the mean score on the Physician Global Impression of Change (PGIC)
scale at Week 6.
Additional information, including patient
eligibility criteria, will be posted shortly at
www.clinicaltrials.gov.
About Revance Therapeutics, Inc.
Revance Therapeutics is an emerging Silicon Valley biotechnology
leader developing neuromodulators for the treatment of aesthetic
and therapeutic conditions. Revance uses a unique proprietary,
peptide excipient technology to create development for a broad
range of aesthetic and therapeutic indications, including glabellar
lines, cervical dystonia, plantar fasciitis, upper limb spasticity
and chronic migraine. RT002 has the potential to be the first
long-acting neuromodulator. The company is advancing a robust
pipeline of 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.
BOTOX® is a registered trademark of Allergan, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements related to the process and timing of, and
ability to complete, current and anticipated future clinical
development of our investigational drug product candidates, the
initiation, enrollment, design, timing and results of our clinical
studies, including the SAKURA Phase 3, ASPEN Phase 3, JUNIPER Phase
2 and other clinical programs relating to RT002, and related
results and reporting of such results; and statements about our
anticipated 2019 objectives, our commercial collaborations, our
ability to obtain, and timing relating to, regulatory approval with
respect to our drug candidates; and potential market form and
benefits of our drug product candidates and our excipient peptide
and other 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 November 2,
2018. 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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version on businesswire.com: https://www.businesswire.com/news/home/20190107005400/en/
INVESTORSRevance Therapeutics, Inc.:Jeanie Herbert(714)
325-3584jherbert@revance.comorBurns McClellan, Inc.:John
Grimaldi(212) 213-0006jgrimaldi@burnsmc.comorMEDIAGeneral
Media:TOGORUN:Mariann Caprino(917)
242-1087m.caprino@togorun.comorTrade Media:Nadine Tosk(504)
453-8344nadinepr@gmail.com
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