Athira's Phase 2/3 LIFT-AD trial of fosgonimeton misses primary endpoint; biomarker data mixed

LeonaBio, Inc.

Primary endpoint GST (p=0.70) and key secondary endpoints ADAS-Cog11 (p=0.35) and ADCS-ADL23 (p=0.61) not met; directionally favored fosgonimeton.
Prespecified subgroups (moderate AD, APOE4 carriers) showed numerically greater treatment effects; e.g., moderate AD ADAS-Cog11 delta -1.16 (p=0.39).
Biomarker p-Tau217 significantly reduced (p<0.01); NfL, GFAP, Aβ42/40 improved directionally.
Preliminary cash resources ~$75.1M as of Aug 31, 2024; ATH-1105 Phase 1 ongoing, completion expected by year-end 2024, ALS patients targeted for 2025.
Fosgonimeton well tolerated; SAEs similar to placebo; 22% early termination rate; full results to be presented at CTAD Oct 29-Nov 1, 2024.

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