Revance Therapeutics reported results from its Phase 2 clinical trial of DaxibotulinumtoxinA for Injection for the management of plantar fasciitis, a painful affliction caused by inflammation of the ligament running along the bottom of the foot (the plantar fascia), the most common cause of heel pain. Although patients reported significant pain reduction that was numerically greater than placebo, the primary efficacy endpoint was not met. Based on these results, Revance will not pursue further development of DaxibotulinumtoxinA for Injection for this indication.
This Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluated the safety and efficacy of two doses of DaxibotulinumtoxinA (DAXI) for Injection in reducing the signs and symptoms of plantar fasciitis. The trial enrolled 155 adult patients with unilateral plantar fasciitis, 18 to 65 years of age, at 17 study centers in the United States. Patients were randomized (1:1:1) to receive an injection of DAXI 80 U, DAXI 120 U or placebo. The primary efficacy endpoint was the change from baseline on the 10-point Numeric Pain Rating Scale (NPRS) score averaged over five days at Week 8. Patients were followed for up to 24 weeks post treatment to assess treatment response, tolerability and safety.
Both doses of DaxibotulinumtoxinA for Injection resulted in significant, measurable pain relief after treatment that was numerically greater than placebo. However, neither dose met the primary efficacy endpoint of statistically significant improvement from baseline in the NPRS for foot pain at Week 8, compared to placebo. Subjects treated with DaxibotulinumtoxinA for Injection showed an average reduction from baseline of 3.29 on the NPRS (a 54.6% reduction) at 80U and 3.25 on the NPRS (a 50.1% reduction) at 120U compared to placebo subjects at 2.75 on the NPRS (a 45.1% reduction).
DaxibotulinumtoxinA for Injection was found to be safe and well-tolerated at both doses through Week 24. There were no serious treatment-related adverse events and no dose dependent increase in adverse events was observed. Treatment-related adverse events were generally transient and mild to moderate in severity. The two most common treatment-related adverse events were (for 80 Units, 120 Units and placebo, respectively) injection site pain (6.1%, 5.6%, 5.8%) and injection site erythema (2.0%, 1.9%, 1.9%).
Revance plans to fully analyze the data, however the company will shift its therapeutic focus to established neuromodulator indications, including muscle movement disorders such as cervical dystonia and upper limb spasticity.
DaxibotulinumtoxinA is a long acting neuromodulator. DaxibotulinumtoxinA combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.
About Plantar fasciitis
Plantar fasciitis is a painful and sometimes debilitating condition caused by the inflammation of the tissue that runs across the bottom of the foot and connects the heel bone to the toes. The pain from plantar fasciitis can become excruciating and chronic that makes work, exercise and ordinary walking challenging and difficult.