Athira Phase 2 ACT-AD misses primary endpoint; monotherapy subgroup shows cognitive benefit

LeonaBio, Inc.

Primary endpoint ERP P300 latency not statistically significant in full mITT population (-6.02 ms vs placebo).
Pre-specified subgroup: combination with AChEIs diminished fosgonimeton effect; post hoc monotherapy showed ERP P300 improvement of -28 ms and ADAS-Cog11 -3.3 points.
Fosgonimeton well tolerated; no treatment-related SAEs or deaths; injection site reaction most common AE.
Study enrolled 77 patients; 14% early termination rate; results to inform ongoing Phase 3 LIFT-AD (NCT04488419).
Management plans to seek regulatory advice on potential adaptations to LIFT-AD based on these findings.

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