Revance Therapeutics, Inc. Announces Interim Phase 2a Results for RT002 in Treating Plantar Fasciitis
January 08, 2018 at 01:00 pm
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Revance Therapeutics, Inc. announced interim 8-week Phase 2a results for its next-generation neuromodulator DaxibotulinumtoxinA for Injection (RT002) in treating plantar fasciitis, a common debilitating form of foot pain. The trial’s primary endpoint, the reduction in the patient-reported visual analog scale (VAS) for pain at Week 8, showed a robust impact on pain, with a greater than 50% reduction for patients treated with RT002. In the intent-to-treat population, a mean reduction in the VAS score of 54.2% from baseline was achieved with RT002, compared with a 42.6% reduction in the placebo group, which upon further subgroup analysis, was driven primarily by a strong placebo response in the control group at two of the five study sites. While not statistically significant (p=0.39), RT002 did outperform placebo, providing patients with considerable pain relief. Similar numeric trends were seen in the secondary and exploratory endpoints. RT002 appeared to be generally safe and well-tolerated through Week 8. The majority of adverse events in both treatment groups were mild in severity. There were no treatment-related serious adverse events. The most common treatment-related adverse events for RT002 and placebo were injection site pain (10.0% and 10.3%) and muscle weakness (3.3% and 3.4%), both respectively, all of which were classified as mild in severity. This Phase 2a prospective, randomized, double-blind, placebo-controlled, multi-center study conducted at five centers in the U.S. is evaluating the safety and efficacy of a single administration of 240 units of DaxibotulinumtoxinA for Injection (RT002) in reducing the signs and symptoms of plantar fasciitis. The trial enrolled a total of 59 male or female subjects, 18 to 65 years of age, with diagnosis of unilateral plantar fasciitis by physical examination and/or ultrasonography. The study’s primary efficacy endpoint is the reduction in the visual analog scale (VAS) for pain in the foot evaluated at Week 8. The secondary endpoints include American Orthopaedic Foot and Ankle Score (AOFAS), Foot and Ankle Disability Index (FADI), and Patient Reported Outcome Measurement Information System (PROMIS). An exploratory efficacy evaluation is the Improvement in the Plantar Fasciitis Pain and Disability Scale (PFPS). Subjects will be followed for a total of 16 weeks post-treatment.
Revance Therapeutics, Inc. is a biotechnology company focused on developing and commercializing aesthetic and therapeutic offerings. The Company's portfolio includes DAXXIFY (DaxibotulinumtoxinA-lanm) for injection and the RHA Collection of dermal fillers in the United States. It has also partnered with Viatris to develop a biosimilar to onabotulinumtoxinA for injection and Fosun to commercialize DAXXIFY in China. Its product/product candidate includes DAXXIFY for glabellar lines indication; DAXXIFY for cervical dystonia indication; RHA Redensity for perioral rhytids indication; RHA 2/ RHA 3/ RHA 4 for facial wrinkles and folds (such as nasolabial folds) indication; DAXXIFY for forehead lines, lateral canthal lines, upper facial lines indication; DAXXIFY for upper limb spasticity indication, and onabotulinumtoxinA biosimilar. The Company has exclusive right to import, market, promote, sell and distribute Teoxane's line of Resilient Hyaluronic Acid dermal fillers.