Revance Therapeutics, Inc. (RVNC), a biotechnology company developing botulinum toxin products for use in treating aesthetic and therapeutic conditions, today announced that it is expanding the Company’s Phase 2 program investigating the use of DaxibotulinumtoxinA for Injection (RT002) for the management of plantar fasciitis from a single center to a multi-center study with protocol updates. Revance expects to report topline results from the Phase 2 study in the fourth quarter of 2017.
“We are very excited about the potential use of RT002 to treat plantar fasciitis, which causes severe pain and inflammation along the bottom of the foot, especially in the heel area,” said Dan Browne, President and Chief Executive Officer at Revance. “We have moved from a single center to a multi-center study protocol, including Wake Forest Baptist Medical Center and two new non-academic study sites, to help us meet our enrollment goals and report topline safety and efficacy results for the plantar fasciitis program before year-end. The combination of a validated visual analog scale (VAS) for measuring the reduction of pain in the foot as a primary endpoint and the improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) as a secondary endpoint provide for clinically meaningful measurements of RT002’s ability to reduce the pain associated with plantar fasciitis. We believe these changes strengthen the Phase 2 program’s capacity to assess the use of RT002 to treat plantar fasciitis.”
The study protocol has been submitted to the U.S. Food and Drug Administration and is scheduled to post on clintrials.gov this week. Recruitment and screening of patients under the new study protocol is already underway.
Phase 2 Study Design
This Phase 2 prospective, randomized, double-blinded, placebo-controlled, multi-center study will evaluate 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. This study is expected to enroll approximately 60 subjects across three centers in the United States. The study’s primary efficacy endpoint is the reduction in the visual analog scale (VAS) for pain in the foot. Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) is one of several secondary endpoints. Subjects will be followed for 16 weeks post treatment.
About Plantar Fasciitis
