Revance says RT002 has 'positive impact' in Phase 2a study
Revance Therapeutics announced interim 8-week Phase 2a results for its next-generation neuromodulator DaxibotulinumtoxinA for Injection 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 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, 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 and muscle weakness both respectively, all of which were classified as mild in severity.