Revance's Injectable Toxin to Enter Phase 3 Trials

It’s game on for Revance Therapeutics, Inc. The company expects to initiate Phase 3 clinical trials of Injectable DaxibotulinumtoxinA (RT002) for the treatment of glabellar lines in the second half of 2016.

Revance is moving forward with an Investigational New Drug (IND) submission for the Phase 3 clinical program and other supportive studies required for Biologics License Application (BLA) filing. This news comes after the company’s Type B / pre-IND / pre-Phase 3 meeting with the U.S. Food and Drug Administration.

The  Phase 3 program will include two placebo-controlled pivotal studies conducted at multiple sites in the US and Canada. The primary endpoint of these studies will be a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity on investigator assessment (IGS-FWS) and patient assessment (PFWS) scales, at maximum contraction (frown), at Week 4. Duration of the reduction of severity of the glabellar lines will be assessed as a secondary endpoint in the Phase 3 pivotal studies. In addition, the Phase 3 program will include a long-term, open-label safety study. Revance plans to announce additional details on the study designs when the company begins dosing patients.