- Poster on display today to be presented during late-breaking
These results are in addition to findings reported on
• DURATION OF EFFECT AT LEAST 24 WEEKS BY DOSE GROUP: The study researchers analyzed efficacy results in two dose groups: Dose Group A (N=21), individuals who received 100 to 240 units of RT002 injectable, and Dose Group B (N=16), receiving 300 to 450 units. Median duration of effect, defined as the number of weeks subjects maintained at least 20% of the treatment benefit achieved at Week 4 (Target TWSTRS Score), was greater than 24 weeks for both dose groups, consistent with the ≥ 24-week duration of effect previously reported in each of the trial's three pre-specified patient cohorts.
• TWSTRS-TOTAL AND SUBSCALE SCORES: RT002 injectable showed a clinically significant mean reduction of the TWSTRS-Total score from baseline at Week 4 - the primary efficacy endpoint - in both Group A (37%) and Group B (39%), with the majority of this benefit maintained through Week 24. In addition, clinically meaningful reductions in TWSTRS-Severity, Disability and Pain subscales were consistent and observed at all time points through Week 24.
• RESPONSE RATES AND PATIENT-RATED QUALITY OF LIFE: A high rate of response was observed in the study, with 94% of subjects at Week 6 experiencing a reduction of at least 20% from baseline in TWSTRS-Total Score, and 68% of subjects at week 24 observed to maintain this treatment benefit at Week 24. In addition, a mean reduction of 37% from baseline in the Cervical Dystonia Impact Profile (CDIP-58) score was observed at Week 6 for all subjects, with the majority of this clinically meaningful benefit maintained through Week 24.
• SAFETY FINDINGS: As previously reported, RT002 injectable appeared to be generally safe and well-tolerated through Week 24 in all treatment groups evaluated. 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, with one case of neck pain reported as severe (day 10 onset, duration of 2 days).
"Cervical dystonia is a movement disorder characterized by involuntary
movements of the head and neck resulting in abnormal twisting postures
of the head that is frequently associated with pain. The treatment of
choice for cervical dystonia is botulinum toxin injections.
Unfortunately, the drawback of this therapy as currently available is
that patients must typically be re-treated at approximately 3 month
intervals in order to maintain benefit," said trial investigator
Additional data at 21st
In addition to the late-breaking poster, a regular session poster with
guided tour is scheduled for
Once the posters are displayed at the congress, the company plans to add a slide presentation of the poster contents to its website under the THERAPEUTICS tab in the section entitled Presentations and Publications.
Based on these Phase 2 results, the company expects to discuss next steps in this clinical program with the US and EU regulatory agencies later this year.
Phase 2 Study Design
Revance's Phase 2 trial is an open-label, sequential, dose-escalating
study to evaluate the safety, preliminary efficacy and duration of
effect of a single treatment of DaxibotulinumtoxinA Injectable (RT002)
for isolated cervical dystonia. Thirty-seven subjects with
moderate-to-severe cervical dystonia were enrolled at multiple sites in
The primary efficacy endpoint of the Phase 2 study was an improvement in dystonia symptoms as measured by change (reduction) from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at four weeks. TWSTRS is a validated composite scale that covers different features of the cervical dystonia condition. The first part of the scale evaluates severity of the condition based on the physical findings of dystonia, the second part rates the patient's perceived level of disability, and the third part rates pain associated with the condition. The study protocol also feature a number of secondary efficacy endpoints.
All subjects were followed for up to a total of 24 weeks after treatment, or until return of symptoms that warrant treatment, at which time subjects could complete the study. Due to the long duration of effect seen in the first cohort, subjects in the second and third cohorts were given the option to continue. Several patients elected to remain in the study and will be followed for up to 36 weeks.
About Cervical Dystonia
According to the
Treatments for cervical dystonia include oral medications, botulinum
toxin injections, surgery, and complementary therapies. Botulinum toxin
can help block the communication between the nerve and the muscle and
may alleviate abnormal movements and postures. Current botulinum toxin
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. It
affects several hundred thousand adults and children in
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 for all indications of 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.
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, 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
News Provided by Acquire Media