Revance Announces Initiation Of Phase 2 Trial Of RT002 Injectable To Treat Plantar Fasciitis

Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced initiation of a Phase 2 placebo-controlled trial of its investigational drug candidate DaxibotulinumtoxinA for Injection (RT002) for the management of plantar fasciitis. This painful affliction, caused by inflammation of the ligament running along the bottom of the foot, is the most common cause of heel pain. Topline clinical results from the Phase 2 trial are expected in 2017.

"The plantar fascia is the foot's shock absorber. Repeated pressure on this tissue, whether from sport activities, aging, or obesity, can create small tears in or overstretch the fascia. The result is inflammation accompanied by sharp, constant pain that often gets worse over time and can become highly debilitating," said Clinical Investigator L. Andrew Koman, MD, Professor and Chair of the Department of Orthopaedic Surgery and Executive Director Musculoskeletal Service Line, Wake Forest School of Medicine. "Preclinical and clinical research suggests a neurotoxin candidate such as RT002 may provide patients with sustained relief from chronic heel pain and support healing of the plantar fascia without the risks of plantar fascia rupture or atrophy of the fat pad that can occur with corticosteroid injections. 1"

An estimated one in 10 people will develop plantar fasciitis during their lifetime. Symptoms can last six months or more, sometimes requiring surgery. 2 In the United States alone, more than two million patients undergo treatment for plantar fasciitis each year. 3

"This Phase 2 study for plantar fasciitis will advance a whole new treatment area for botulinum toxin that addresses pain and muscle tightness. Revance has the opportunity to be a first mover for this indication and other musculoskeletal disorders," said Dan Browne, President and Chief Executive Officer at Revance. "No botulinum toxin is approved for treating plantar fasciitis; however, the clinical endpoints are well validated. Published estimates place the annual U.S. evaluation and treatment market for plantar fasciitis at more than $250 million, and we believe the market could grow significantly larger if patients had a compelling neurotoxin treatment option."

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