Revance Therapeutics Inc announces the interim Phase 2a results for its next-generation neuromodulator DaxibotulinumtoxinA for Injection (RT002) in treating plantar fasciitis.
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, explains a media release from Revance.
“This initial proof-of-concept study demonstrates that RT002 may have a positive impact on the severe heel pain caused by plantar fasciitis,” says Dan Browne, co-Founder, president, and chief executive officer of Revance, in the release.
“The substantial reduction in the VAS with RT002 at Week 8 is consistent with prior neuromodulator studies in plantar fasciitis. This data provides a rich resource to understand plantar fasciitis and how to best treat the pain associated with this condition using a neuromodulator. We plan to complete this study and review the full data set.
“Further, before moving to a Phase 2b trial later this year as previously planned, we now expect to conduct another Phase 2a trial with a modified design to demonstrate the ability of RT002 to treat plantar fasciitis.”
[Source: Revance Therapeutics Inc]