Revance has begun its phase 2 placebo-controlled trial for DaxibotulinumtoxinA (RT002) for injection.
Revance has begun its phase 2 placebo-controlled trial for DaxibotulinumtoxinA (RT002) for injection. The drug is being assessed for the potential management of plantar fasciitis, which is the most common cause of heel pain. Clinical results from the trial are expected to come in 2017.
The randomized and double-blinded phase 2 study was created to assess the safety and efficacy of a single administration of RT002. Approximately 60 people from the United States will be involved in the trial.
“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,” said clinical investigator L. Andrew Koman, MD, in a press release.
The preliminary efficacy endpoint of the study is the improvement in the American Orthopaedic Foot and Ankle Score. Participants will be monitored for 16 weeks after receiving the treatment.
“This phase 2 study for plantar fasciitis will advance a whole new treatment area for botulinum toxin that addresses pain and muscle tightness,” said Dan Browne, president and chief executive officer at Revance, in a press release. “Revance has the opportunity to be a first mover for this indication and other musculoskeletal disorders.”
DaxibotulinumtoxinA is also in development for the treatment of glabellar lines and cervical dystonia.