ATX-101: Additional Phase III data
Additional data from the double-blind, European Phase III Study 17 trial in 360 patients showed that 2 mg/cm 2 ATX-101 significantly improved mean CR-SMFRS score, a co-primary endpoint, by 0.77 points from baseline to week 24 vs. 0.36 points for placebo (p<0.0001). Additionally, 64.8% of patients receiving ATX-101 achieved an undisclosed pre-defined categorical change using SSRS score at week 24 vs. 29.3% for placebo (p<0.001).
On patient-reported outcomes, ATX-101 significantly reduced mean PR-SMRS score by 0.94 points from baseline to week 24 vs. 0.41 points for placebo (p<0.0001), while 84.8% of patients receiving ATX-101 expressed satisfaction with treatment on the Global Post-Treatment Satisfaction Scale at week 24 vs. 58.1% for placebo (p<0.01). Patients received once-monthly 1 or 2 mg/cm 2 ATX-101 or placebo. Data were presented at the Cosmetic Surgery International Multispecialty Symposium in Las Vegas. ...