First Phase 1 safety study of fosigotifator starts in people with ALS

Calico/Fosigotifator (ABBV-CLS-7262)

The AbbVie-sponsored Phase 1 study of fosigotifator in ALS started on September 22, 2021, with a 4-week placebo-controlled part followed by up to 152 weeks of open-label treatment. The trial was later terminated in July 2025 after enrolling 31 people, following the drug's failure to meet primary endpoints in the Phase 2/3 HEALEY platform trial.

• Phase 1 study in ALS: 4-week placebo-controlled period followed by up to 152 weeks open-label.
• Enrolled 31 people before termination in July 2025.
• Fosigotifator is a small molecule that activates EIF2b to restore protein synthesis under cellular stress.
• Study termination followed failure to meet primary ALS progression endpoint in Phase 2/3 HEALEY trial.