Fosigotifator misses primary endpoint in HEALEY ALS platform trial

Calico/Fosigotifator (ABBV-CLS-7262)

Calico reported that fosigotifator, an eIF2B activator developed with AbbVie, did not meet the primary endpoint of combined disease progression (function and mortality) at either dose in Regimen F of the HEALEY ALS Platform Trial. Secondary endpoints measuring functional decline also showed no statistically significant difference from placebo.

• Fosigotifator is eIF2B activator targeting Integrated Stress Response pathway implicated in ALS pathogenesis.
• Failed primary endpoint: combined measure of disease progression (function and mortality) at both primary and exploratory high doses.
• Secondary functional decline endpoints also negative; however, potential signals in muscle strength and respiratory function at exploratory dose warrant investigation.