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     111  0 Kommentare Revance Announces Positive Topline Phase 2 Data Supporting Advancement of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity

    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.

    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.

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    Revance Announces Positive Topline Phase 2 Data Supporting Advancement of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity 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 …

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