other material
confidence high
sentiment neutral
materiality 0.70
AEON Biopharma Phase 2 migraine trial misses primary endpoint; secondary endpoints statistically significant
AEON Biopharma, Inc.
- Primary endpoint not met: mean MMD reduction of 4.8 days (150U) and 5.0 days (195U) vs 4.2 days placebo; p-values not significant (0.2844, 0.1711).
- Secondary endpoint: 69% of 195U dose achieved ≥50% MMD reduction vs 52% placebo (p=0.0132); 75% reduction significant for both doses.
- Safety profile favorable; Company plans to advance to Phase 3 and request end-of-phase 2 FDA meeting in H1 2024.
- Ongoing Phase 2 for chronic migraine to complete enrollment in Q4 2023; topline data expected in H2 2024.