ATX-101: Additional Phase III data
Additional data from the double-blind, European Phase III Study 16 trial in 363 patients showed that monthly 2 mg/cm 2 ATX-101 for up to 4 treatment cycles significantly improved mean CR-SMFRS score, a co-primary endpoint, by 0.9 points from baseline to week 24 vs. 0.22 points for placebo (p<0.001). Additionally, 66.1% of patients receiving ATX-101 achieved an undisclosed pre-defined categorical change using SSRS score at week 24 vs. 28.7% for placebo (p<0.001).
On patient-reported outcomes, ATX-101 significantly improved mean PR-SMFRS score by 0.98 points from baseline to week 24 vs. 0.32 points for placebo (p<0.001), while 86% of patients receiving ATX-101 expressed satisfaction with treatment on the Global Post-Treatment Satisfaction Scale at week 24 vs. 45% for placebo (p<0.001). Patients received once-monthly 1 or 2 mg/cm 2 ATX-101 or placebo. Kythera did not disclose data for the 1 mg/cm 2 dose. Data were presented at the American Society for Aesthetic Plastic Surgery meeting in Montreal. ...