Revance Doses First Patient in ASPEN Phase 3 Clinical Program of RT002 Injectable for the Treatment of Cervical Dystonia
- RT002 Injectable has potential to be first long-acting neuromodulator for treatment of a debilitating involuntary muscle movement disorder -
“In our Phase 2 study, treatment with RT002 resulted in patients
realizing clinically meaningful relief from the pain and disability
associated with cervical dystonia for at least 24 weeks,” said
“The initiation of our pivotal program is an important milestone for
Revance as we advance our novel long-lasting neuromodulator RT002 in
this important therapeutic indication,” said
Positive results from the company’s open-label, dose-escalating Phase 2 clinical study of RT002 injectable in the treatment of cervical dystonia were recently published in Movement Disorders Clinical Practice. The trial demonstrated a median duration of effect of at least 24 weeks for each of the three dose cohorts studied. For reference, current treatment of cervical dystonia calls for injection of botulinum toxin approximately every three months (12 weeks), or four times per year.
The Phase 2 trial achieved its primary efficacy endpoint, demonstrating
a clinically significant mean reduction of 38 percent in the
Regarding the Phase 2 study’s key secondary endpoint – percentage of responders showing improvement on Clinician Global Impression of Change (CGIC) – 97 percent of all patients experienced an improvement in cervical dystonia symptoms at Week 4. In all three cohorts, RT002 injectable appeared to be generally safe and well-tolerated through Week 24. There were no serious adverse events and no dose-dependent increase in adverse events. The treatment-related adverse events were generally transient and mild to moderate in severity, with one case of neck pain reported as severe. The most common adverse events were dysphagia, or difficulty in swallowing (14 percent), of which all cases were mild in severity, injection site redness (8 percent), injection site bruising (5 percent), injection site pain (5 percent), muscle tightness (5 percent) and muscle weakness (5 percent).
The global neuromodulator opportunity for muscle movement disorders in
2017 was estimated to be more than
ASPEN Phase 3 Clinical Program in Cervical Dystonia
The company’s ASPEN Phase 3 clinical program consists of two trials to
evaluate the safety and efficacy of RT002 injectable for the treatment
of cervical dystonia in adults: 1) a randomized, double-blind,
placebo-controlled, parallel group trial, and 2) an open-label,
long-term safety trial. The program is expected to enroll a total of
approximately 300 patients at multiple sites in
Randomized Trial: Patients will be randomized to either a low dose or high dose of RT002 injectable or placebo treatment. Post-treatment, patients will be followed for a maximum of 36 weeks. The primary efficacy endpoint of the trial will be the change from baseline in the TWSTRS – Total score. Key secondary endpoints include the duration of treatment effect, the Clinical and Patient Global Impression of Changes, and adverse events. Further, the trial features exploratory efficacy assessments, including the Cervical Dystonia Impact Profile (CDIP)-58, a disease-specific, patient-rated questionnaire that measures quality of life.
Open-Label Trial: Patients will receive up to four continuous treatment cycles of RT002 injectable over the 52-week observation period. Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with RT002. Key secondary endpoints are the change from baseline in TWSTRS – Total score, and the duration of treatment effect, as well as overall treatment response based on the Clinical and Patient Global Impression of Change.
Additional information about the ASPEN Phase 3 program, including patient eligibility criteria, will be posted shortly at www.clinicaltrials.gov.
About Cervical Dystonia
According to the
Treatments for cervical dystonia include oral medications,
neuromodulator (botulinum toxin) injections, surgery, and complementary
therapies. Neuromodulators blocks the communication between the nerve
and the muscle, relaxing the muscle, which alleviates abnormal
involuntary movements and postures. Current neuromodulator treatments
for cervical dystonia have a duration of effect of approximately three
months. Cervical dystonia can occur at any age, although most
individuals first experience symptoms in middle age. The condition
affects a few hundred thousand adults and children in
About Revance Therapeutics, Inc.
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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
"
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Source:
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
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