[{"id":"aerify2-aer","name":"Annualized moderate-to-severe COPD exacerbation rate at Week 52","type":"PRIMARY","unit":"rate ratio","results":[{"notes":"MISSED primary endpoint at 52 weeks. Benefit seen at 24 weeks but did not sustain.","value":null,"arm_id":"itepe-q2w-aerify2","arm_name":"Itepekimab Q2W"}],"timepoint":"Week 52","description":"Same endpoint as AERIFY-1. AERIFY-2 was the smaller companion trial (n=953 vs n=1127)."}]

AERIFY-2 MISSED primary endpoint at 52 weeks. Benefit was observed at earlier timepoints (24 weeks) but did not reach significance at 52 weeks. COVID pandemic reduced overall exacerbation rates across all arms, reducing statistical power. AERIFY-2 was the smaller trial (n=953 vs 1127) and was hit harder by this power loss.

AERIFY-2 (n=953): AEs 64% (Q2W) vs 64% (placebo). Serious infections 10% (Q2W) vs 7% (placebo). Deaths 3% vs 2%.

AERIFY-2 miss is a setback but not fatal. The COVID confounder (lower-than-expected exacerbation rates) is well-documented across multiple COPD trials in this era. The smaller sample size (953 vs 1127) amplified the power loss. Regulatory path likely depends on congress data presentation and FDA advisory committee.

Confirmatory companion to AERIFY-1. Same design, slightly smaller enrollment.