- Completes Type B Pre-BLA meeting with U.S.
- Initiates Phase 2 trials for RT002 in both plantar fasciitis and adult upper limb spasticity -
“Revance is entering 2019 with tremendous momentum on multiple fronts,”
said
REGULATORY UPDATE AND MILESTONES
In December of 2018, the company completed its pre-Biologics Licensing
Application (BLA) meeting with the
In February of 2018, Revance announced a collaboration and license
agreement with
“We have a strong conviction in our ability to create a biosimilar to
BOTOX® under the 351(k) pathway,” said
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
ASPEN Phase 3
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
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
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
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
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
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
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
Additional information, including patient eligibility criteria, will be posted shortly at www.clinicaltrials.gov.
About
“Revance Therapeutics” and the Revance logo are registered trademarks of
BOTOX® is a registered trademark of
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 clinicalprograms 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 andbenefits 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20190107005400/en/
Source:
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert
(714)
325-3584
jherbert@revance.com
or
Burns
McClellan, Inc.:
John Grimaldi
(212) 213-0006
jgrimaldi@burnsmc.com
or
MEDIA
General
Media:
TOGORUN:
Mariann Caprino
(917) 242-1087
m.caprino@togorun.com
or
Trade
Media:
Nadine Tosk
(504) 453-8344
nadinepr@gmail.com