摘要

Objectives: To demonstrate the efficacy and safety of ATGC-110 in the treatment of subjects with moderate-to-severe glabellar lines (GLs). Introduction: This was a multicenter, randomized, double-blind, active-controlled, non-inferiority, phase 3 clinical trial comparing the efficacy and safety of 20 units (U) of ATGC-110 and 20 U of incobotulinumtoxinA in the treatment of subjects with moderate-to-severe GLs. Materials / method: Baseline (BL) and post-treatment assessments were made using a validated 4-point facial wrinkle scale (FWS), a 9-point subject global assessment of change scale (GACS), and a 7-point subject satisfaction assessment scale (SSAS). Primary efficacy was assessed for the per protocol set (PPS) at Week 4 and was the proportion of subjects with 0 (none) or 1 (mild) on the FWS at maximum frown and improvement of at least 2-points from BL based on the investigator’s live assessment. Secondary efficacy endpoints and adverse events also were assessed. Results: Subjects (N=298) had a mean (SD) age of 48.6 (8.77) years and were mostly female (79.9%) and moderate (63.1%) in GL severity at BL. For ATGC-110 subjects, 85.1% were responders on the primary endpoint compared to 68.1% for incobotulinumtoxinA subjects (p=0.0010). The difference of proportion [95% CI] was 0.17 [0.06, 0.27]; CI lower bound exceeded the non-inferiority margin of -0.15. Additional efficacy results to be reported to Week 16. Treatment-emergent adverse events (TEAEs) were mostly mild and occurred at similar frequencies among ATGC-110 (9.4%) and incobotulinumtoxinA (6.6%) subjects. Conclusion: ATGC-110 is a novel, investigational, 150 kDa botulinum neurotoxin type A drug product, free of neurotoxin associated proteins (NAPs). In this Korean phase 3 trial, ATGC-110 significantly reduced GL severity and was associated with a favorable safety profile. ATGC-110 was shown to be non-inferior to incobotulinumtoxinA in the treatment of moderate-to-severe GLs at Week 4.