AbbVie starts a Phase 1b study of fosigotifator in major depressive disorder

Calico/Fosigotifator (ABBV-CLS-7262)

AbbVie began a double-blind, randomized, placebo-controlled Phase 1b study of fosigotifator (ABBV-CLS-7262) in adults with major depressive disorder on October 23, 2024. The study assesses the safety and effect of the eIF2B activator on depression, expanding its evaluation beyond ALS.

• Phase 1b study: double-blind, randomized, placebo-controlled design in adults with major depressive disorder.
• Fosigotifator activates eIF2B, targeting the Integrated Stress Response pathway implicated in neurodegeneration and mood.
• Expands clinical evaluation beyond ALS to psychiatric indication based on mechanism potentially relevant to depression.