Revance’s Botox Competitor Fails to Meet Efficacy End Point in Phase 2 Trial

Revance’s fight to compete in the onabotulinumtoxinA (Botox) market hit a snag when its drug candidate failed to meet the efficacy primary end point in a study.

Results from a phase 2 study revealed that a daxibotulinumtoxinA (DAXI) candidate developed by Revance Therapeutics as a competitor to Botox (onabotulinumtoxinA) did not meet primary efficacy end points.

“While we are disappointed with these phase 2 results, it’s important to note that no other neuromodulator has been approved for the treatment of plantar fasciitis, which is a new therapeutic category with an underlying physiology that is different from currently approved indications for muscle movement and pain disorders that utilize neuromodulators,” Mark Foley, president and CEO at Revance, said in a statement.

Revance, based in Newark, California, created daxibotulinumtoxinA in addition to a biosimilar for Botox, which is being developed in partnership with Mylan, to help garner more of the blockbuster drug’s market share once competitors gain access to the market.

Details of the Trial

In the prospective, randomized, double-blind, multicenter, placebo-controlled trial, 155 adult patients with unilateral plantar fasciitis, a condition that results in inflammation of the skin on feet and causes heel pain, were randomized 1:1:1 to receive an injection of DAXI 80 U, DAXI 120 U, or a placebo.

Results of the trial found that neither dose of daxibotulinumtoxinA met the primary end point of statistically significant improvement from baseline using the 10-point Numeric Pain Rating Scale (NPRS) score representing an average over 5 days at week 8 compared with the placebo group.

Physicians continued to track patients up until week 24 after receiving treatment to assess whether daxibotulinumtoxinA was safe and tolerable.

Trial subjects showed to have an average reduction from baseline of 3.29 on the NPRS (54.6%) at 80 U (P = .2135 vs placebo) and a reduction of 3.25 on the NPRS (50.1%) at 120 U (P = .2205 vs placebo, P = .9207 vs 80 U), compared to a 2.75 reduction on the NPRS (45.1%) for subjects who received the placebo.

However, daxibotulinumtoxinA was found to be safe and tolerable for both doses through week 24. No serious treatment-related adverse events (AEs) were reported and no dose dependent increase in adverse events were observed. Treatment-related AEs tended to be mild to moderate in severity and lasted for a short period of time.

The 2 most common AEs attributed to the drug were injection site pain (6.1% for 80 U, 5.6% for 120 U, 5.8% for placebo) and injection site erythema (2.0% for 80 U, 1.9% for 120 U, 1.9% for placebo).

More on DaxibotulinumtoxinA

In October 2020, Revance reported positive efficacy, safety, and tolerability findings for daxibotulinumtoxinA from the ASPEN-1 phase 3 trial, which supported that the agent could reduce physician visitations and have prolonged effectiveness compared with Botox. The trial assessed the effects of daxibotulinumtoxinA in 301 patients over 36 weeks.

“Though we plan to further analyze the plantar fasciitis data, we will primarily focus our therapeutic efforts on established neuromodulator indications, including muscle movement disorders where our positive ASPEN-1 Phase 3 cervical dystonia results are a source of confidence,” said Foley.

In June 2020, Revance announced positive results from 2 phase 2a studies on how daxibotulinumtoxinA performed at treating forehead lines, frown lines, and crow’s feet.

Foley said he expects results from the JUNIPER phase 2 trial testing daxibotulinumtoxinA in patients with upper limb spasticity in the first quarter of 2021.