– Oral poster showcasing positive results from Revance’s Phase 2 JUNIPER clinical trial, which demonstrated long-term efficacy and safety with DAXXIFY™ for the treatment of upper limb spasticity (ULS) in adults after stroke or traumatic brain injury
– Study results indicate that DAXXIFY™ at the 500U dose is effective and well tolerated for treating adult ULS
– Study results demonstrated DAXXIFY™ had a median duration of response of 24 weeks
Revance Therapeutics, Inc. (NASDAQ:RVNC), a commercial stage biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced an oral presentation by Dr. Atul Patel, JUNIPER clinical investigator, will take place on Friday, September 16 at 2:30 pm GMT+ 2 at the International Congress of Parkinson’s Disease and Movement Disorders (MDS Congress) in Madrid, Spain. The presentation will include results from Revance’s JUNIPER Phase 2 clinical trial evaluating the efficacy and safety of three doses of DAXXIFY™ compared to placebo for adults with upper limb spasticity (ULS) after stroke or traumatic brain injury.
DAXXIFY™ was found to be effective and well tolerated for treating adult ULS in the Phase 2 JUNIPER study. The duration of response observed in JUNIPER suggests that DAXXIFY™ has the potential to reduce the frequency of adult ULS treatments by up to 50% annually.
“As an investigator in the JUNIPER trial, I am delighted to present data from JUNIPER for the first time at this year’s MDS Congress,” said Atul Patel, MD, and Medical Director, Kansas Institute of Research. “The data indicates that duration for DaxibotulinumtoxinA for Injection is strong and has the potential to reduce the frequency of adult upper limb spasticity treatments, delivering improvement in patients’ quality of life and the opportunity to expand treatment care. With current treatments, 60% of patients report spasticity symptoms return less than 3 months after treatment. 1 The need for a new treatment option is considerable as patients have overwhelmingly indicated the desire for a longer lasting option.”
The JUNIPER Phase 2 study showed that of the three doses studied (250U, 375U, and 500U), the 500U dose of DAXXIFY™ met one of the co-primary endpoints at the pre-specified timepoint (Week 6) and found statistical significance for both co-primary endpoints when analyzed post hoc (Week 4). The study also demonstrated a median duration of response of 24 weeks, while being generally well tolerated. The results from this Phase 2 trial further demonstrate the efficacy, safety and durability of Revance’s unique neuromodulator formulation in a second therapeutic application following the previously reported results in cervical dystonia and informs dosing strategy for the adult upper limb spasticity Phase 3 program.
Oral Presentation & Poster:
- Title: DaxibotulinumtoxinA for Injection in Adults with Upper Limb Spasticity After Stroke or Traumatic Brain Injury: A Randomized Placebo-Controlled Study (JUNIPER)
- Presented by: Dr. Atul T. Patel
- Authors and Affiliations: Atul T. Patel, Kansas City Bone & Joint Clinic, Overland Park, KS; Michael C. Munin, University of Pittsburgh School of Medicine, Pittsburgh, PA; Ziyad Ayyoub, Rancho Los Amigos Rehabilitation Center, UCLA, Downey, CA, and Western University of Health Sciences, Pomona, CA; Gerard E. Francisco, University of TexasHealth Science Center at Houston McGovern Medical School, Houston, TX, and TIRR Memorial Hermann, Houston, TX; Todd M. Gross, Revance Therapeutics, Inc., Nashville, TN, US; Roman G. Rubio, Revance Therapeutics, Inc., Nashville, TN, USA (Former employee); J. Patrick Kesslak, Revance Therapeutics, Inc., Nashville, TN, USA (Former employee)
