— Data validated efficacy and safety and informs dosing strategy for Phase 3 program
— Achieved key co-primary endpoint on efficacy, with 500U dose demonstrating statistically significant difference from placebo in the Modified
— Numerical improvement compared with placebo achieved with all three doses on the Physician Global Impression of Change (PGIC) assessment, but did not reach statistical significance with the study’s reduced enrollment due to COVID-19
— Median duration of response of at least 24 weeks demonstrated in all three doses (250U, 375U, 500U)
— Treatment was generally safe and well tolerated in all three doses
— Company to discuss results on Fourth Quarter 2020 Earnings Conference Call at
The JUNIPER study was designed to evaluate the efficacy and safety of DaxibotulinumtoxinA for Injection for adults with upper limb spasticity after stroke or traumatic brain injury and to identify a dose to advance into a Phase 3 program. Three doses (250 units, 375 units, 500 units) were studied and subjects were randomized in a 1:1:1:1 ratio across the active doses or placebo. The trial was originally designed to include 128 subjects. Due to the ongoing COVID-19 challenges related to continued subject enrollment and the scheduling of in-person study visits, Revance made the decision in
“As an investigator in the JUNIPER trial, I am delighted to see the efficacy and safety data that will support the advancement of DaxibotulinumtoxinA for Injection in adult upper limb spasticity,” said
The study’s co-primary endpoints were improvement from baseline in the Modified
On a key secondary endpoint, DaxibotulinumtoxinA for Injection delivered a median duration of at least 24 weeks across all three doses. Duration of effect was defined as the time from injection (in weeks) until the loss of improvement as measured by the MAS (for the suprahypertonic muscle group or SMG) and the PGIC, or a request for retreatment by the subject.
All three doses of DaxibotulinumtoxinA for Injection were generally safe and well tolerated with no increase in the incidence of adverse events observed in the higher dose treatment groups. The majority of treatment-related adverse events were mild or moderate in severity and were similar to or lower than those reported in prior botulinum toxin studies in adult upper limb spasticity.
“I am very proud of our team and their efforts to successfully complete our Phase 2 trial during what has proven to be a very challenging time for trial enrollment and follow up,” said
The company plans to discuss the results today during its Fourth Quarter / Year End 2020 Earnings Conference Call at
The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.
About JUNIPER Phase 2 Study
The company’s JUNIPER study was a Phase 2, randomized, double-blind, placebo-controlled, parallel group, dose-ranging, multi-center trial to evaluate the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of adult upper limb spasticity in adults following stroke or traumatic brain injury. The study was conducted at 30 sites in
Results will be submitted for presentation at an upcoming medical congress. Additional information about the JUNIPER Phase 2 study can be found at www.clinicaltrials.gov.
About Upper Limb Spasticity
Upper limb spasticity is a neurological condition that affects the ability to move the arms and can affect hands, fingers, wrist, forearm, elbow and shoulder. It occurs most commonly after a stroke or brain injury.2 Although not life-threatening, it can be painful, effecting a patient’s ability to perform daily tasks, such as getting dressed and hygiene care. The prevalence of spasticity (upper limb and lower limb spasticity) is estimated to be 12 million people worldwide yet less than 20% of patients seek treatment.3
Botulinum toxin treatment is the standard of care for management of upper limb spasticity.4 Other treatments include oral and intrathecal muscle relaxants, physical therapy, splints, casts & braces, electrical stimulation, and surgery.2
Long-acting symptom relief is a current unmet need for upper limb spasticity patients as the benefits of currently approved botulinum toxin treatments lasts for a median duration of approximately 3 months.4 Spasticity, one of the largest of the muscle movement disorder indications, is a
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Any statements in this press release that are not statements of historical fact, including statements related to the clinical development of investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of adults with moderate to severe focal upper limb spasticity, including the JUNIPER study, and the potential benefits of our drug product candidates constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to successfully compete with treatments and therapies; our ability to achieve, and the rate and degree of commercial acceptance and the market, size and growth potential of our drug product candidates, if approved; our ability to successfully commercialize our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; 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 our periodic filings with the
December 2020-Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021
American Associationof neurological Surgeons. Retrieved from: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity
- What is spasticity? Life with Spasticity. Retrieved from: https://lifewithspasticity.com/efinition-and-prevalence#definition.
Simpson. BoNTA Practice Guidelines. Neurology
Jenifer Slaw, 347-971-0906
Nadine Tosk, 504-453-8344