Revance Announces Last Patient Enrolled in Modified JUNIPER Phase 2 Upper Limb Spasticity Trial of DaxibotulinumtoxinA for Injection
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced a decision to complete enrollment in its JUNIPER Phase 2 trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury. Due to ongoing COVID-19 concerns related to subject enrollment and scheduling in-person study visits, the company has chosen to end screening and complete the study with 76 subjects enrolled, along with a few subjects currently being evaluated for participation in the study. The 73 subjects dosed before enrollment was paused in March due to COVID-19 will be followed for up to 36 weeks; subjects enrolled after this will be followed to Week 12. Revance now expects to announce topline data from the JUNIPER Phase 2 trial in early 2021.
“In announcing the close of enrollment for our JUNIPER Phase 2 trial, we are taking a pragmatic approach and making a proactive decision in light of the ongoing COVID-19 pandemic,” said Roman Rubio, M.D., Senior Vice President of Clinical Development at Revance. “Fortunately, we have enrolled approximately two-thirds of the initial target subjects, which will produce phase 2 trial data that provides adequate information to advance our clinical program in upper limb spasticity.”
Added Mark Foley, President and Chief Executive Officer, “While the vast majority of our clinical development programs for DaxibotulinumtoxinA for Injection have been unaffected by the coronavirus pandemic, the one exception has been our JUNIPER trial, as previously communicated. We announced a pause in enrollment due to challenges in ongoing recruitment and subject monitoring due to social distancing. As COVID-related concerns have continued, we reassessed our assumptions and timeline, concluding that truncating the Phase 2 trial now could potentially allow us to move into the pivotal Phase 3 upper limb spasticity trials earlier than originally planned, while also avoiding patient enrollment during this challenging time.”