Revance Therapeutics Inc announces it has completed the enrollment of patients in a Phase 2 program investigating the use of DaxibotulinumtoxinA for Injection (RT002) for the management of plantar fasciitis.
A total of 59 patients across five centers in the United States were enrolled in the Phase 2 program. It is expected that topline 8-week results, along with primary and secondary endpoints and safety data, will be reported by the end of the year.
“One in 10 people will develop plantar fasciitis pain in their lifetime and more than two million patients in the US undergo treatment annually. No neuromodulator has been approved for the treatment of this debilitating pain indication, and current treatments do not provide fast, sustained pain relief,” says Dan Browne, president and chief executive officer at Revance, in a media release.
“RT002 is unlike any other neuromodulator, with potential to provide improved outcomes and patient experience over existing treatments. We are eager to report topline data for plantar fasciitis before year end.”
This Phase 2 study is evaluating the safety and efficacy of a single administration of Revance’s investigational drug candidate DaxibotulinumtoxinA for Injection (RT002) in reducing the signs and symptoms of plantar fasciitis. The study’s primary efficacy endpoint is the reduction in the visual analog scale (VAS) for pain in the foot evaluated at Week 8. Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) is one of several secondary endpoints. Subjects will be followed for a total of 16 weeks post treatment, the release explains.
Silicon Valley-based Revance Therapeutics Inc is a biotechnology company that develops botulinum toxin products for use in aesthetic and therapeutic conditions.
[Source: Revance Therapeutics Inc]