Revance (RVNC) Announces Positive Topline Phase 2 Data Supporting Advancement of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity
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Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced positive topline data from its JUNIPER Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical trial of its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of adults with moderate to severe upper limb spasticity.
- 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 Ashworth Score (MAS) improvement from baseline
- 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
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 June 2020 to curtail enrollment at 83 subjects.
“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 Atul Patel, MD, MHSA, Medical Director, Kansas Institute of Research. “What impresses me most is the duration of effect covering at least 24-weeks across all dose groups studied, while also being well tolerated. The need for longer duration botulinum toxin treatments for upper limb spasticity is considerable, as the frequent re-emergence of symptoms around 12 weeks continues to be a painful, costly and a time-consuming burden for patients. The data indicates that DaxibotulinumtoxinA for Injection has the potential to reduce the frequency of adult upper limb spasticity treatments by up to 50% annually, delivering meaningful pharmacoeconomic benefits, improvement in patients’ quality of life, and the opportunity to expand treatment care.”
The study’s co-primary endpoints were improvement from baseline in the Modified Ashworth Score (MAS) and the Physician Global Impression of Change (PGIC) score at Week 6. In the JUNIPER study, proof of concept was demonstrated with all three doses being numerically higher than placebo for the improvement in the MAS score, with the 500-unit dose demonstrating a clinically meaningful and statistically significant reduction from baseline in muscle tone versus placebo (p=0.0488). Additionally, each of the three doses demonstrated a numerical improvement compared with placebo on the PGIC assessment but did not reach statistical significance with the reduced enrollment.
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 Mark J. Foley, President and Chief Executive Officer at Revance. “Although we reduced the subject enrollment size in response to COVID-19 concerns, we were able to generate sufficient data to inform our dosing strategy for our Phase 3 program, while also demonstrating a long duration profile that is consistent across our therapeutic and aesthetic clinical programs. Our next step is to schedule an end-of-Phase 2 meeting with the FDA prior to finalizing a Phase 3 program. I want to thank the patients, investigators, CROs and the Revance team for their time and commitment in making this trial possible.”
The company plans to discuss the results today during its Fourth Quarter / Year End 2020 Earnings Conference Call at 4:30 p.m. ET. Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1678310; or from the webcast link in the investor relations section of the company’s website at: www.revance.com. A replay of the call will be available beginning February 22, 2021 at 4:30 p.m. PT/7:30 p.m. ET to February 23, 2021 at 4:30 p.m. PT/7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 1678310.
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 the United States and has enrolled 83 male and female patients between the age of 18 to 75 years old. Patients were randomized into one of four treatment groups: 275 units, 350 units, 500 units and placebo. The study was designed to run up to 36 weeks, with two co-primary outcome measures: mean change from baseline in muscle tone measured with the MAS in SMG of the elbow, wrist, or finger flexors at Week 6; and mean score of the PGIC at Week 6. The first 73 subjects, who were dosed before enrollment was paused in March due to the COVID-19 pandemic, were followed up for 36 weeks, and the succeeding 10 subjects were followed up to Week 12.
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.
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