Shots:
- P-III (AERIFY-1 & AERIFY-2) trials assessed itepekimab (SC, Q2W or Q4W) vs PBO as an add-on therapy in pts (40-85yrs.) with mod. to sev. COPD, who haven’t smoked for ≥6mos.; data to be discussed with regulatory bodies
- AERIFY-1 (n=1127) met its 1EP of reduced exacerbations, with Q2W (n=375) showing a 27% reduction at Wk. 52 & a 30% decrease at Wk. 24, while Q4W (n=377) reduced them by 34% & 21% at Wk. 24 & 52, respectively vs PBO (n=375)
- AERIFY-2 (n=953) did not meet the 1EP, with Q2W (n=326) showing a 18% & 2% decrease at Wk. 24 & 52 respectively, while Q4W (n=303) depicted a reduction of 21% & 12% at Wk. 24 & 52 vs PBO (n=324); fewer-than-expected exacerbations reduced power of both trials, likely due to enrollment during COVID-19
Ref: Regeneron| Image: Regeneron & Sanofi| Press Release
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