NEWARK, CA, USA I May 1, 2017 I Revance Therapeutics, Inc. (NASDAQ: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

Heel pain is the most common complaint of patients who visit podiatrists and orthopeadic foot and ankle surgeons. Eighty percent of reported heel pain complaints are due to plantar fasciitis, which is caused by inflammation of the connective tissue in the arch of the foot.1 Plantar fasciitis is estimated to affect 10 to 18 million individuals in the United States annually.2 Risk factors include age, long distance running, excessive weight, abnormal foot posture, use of poor foot wear, and repetitive trauma.3

Treatment options for less severe cases include leg and foot stretching exercises, nonsteroidal anti-inflammatory drugs, shoe inserts, heel pads, and night splints. More severe or refractory cases are currently treated with steroid injections, extracorporeal shock wave therapy, platelet rich plasma injections, and/or surgery.4

About Revance Therapeutics, Inc.

Revance, a Silicon Valley-based biotechnology company, is committed to the advancement of remarkable science. The company is developing a portfolio of products for aesthetic medicine and underserved therapeutic specialties, including dermatology, orthopedics and neurology. Revance’s science is based upon a proprietary peptide technology, which when combined with active drug molecules, may help address current unmet needs. Revance’s initial focus is on developing daxibotulinumtoxinA, the company’s highly purified botulinum toxin, for a broad spectrum of aesthetic and therapeutic indications, including facial wrinkles and muscle movement disorders.

The company’s lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis with the potential to be the first long-acting neuromodulator. The company holds worldwide rights to RT002 injectable and RT001 topical and the pharmaceutical uses of its proprietary peptide technology platform. More information on Revance may be found at www.revance.com.

SOURCE: Revance Therapeutics