FDA Grants Fast Track Designation to Bristol Myers Squibb’s Alzheimer’s Antibody BMS-986446

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, a promising anti-microtubule binding region-tau (anti-MTBR-tau) antibody currently in Phase 2 development for early Alzheimer’s disease. The designation is designed to accelerate the development and review of drugs targeting serious conditions with unmet medical needs.

Alzheimer’s disease is a progressive neurodegenerative disorder characterized by the accumulation and spread of pathological tau protein, which causes neuronal death and cognitive decline. BMS-986446 targets fragments of tau containing the microtubule binding region, aiming to neutralize their spread and promote clearance, potentially slowing or delaying disease progression.

Laura Gault, senior vice president and head of development for Neuroscience at Bristol Myers Squibb, emphasized the urgency for innovative Alzheimer’s therapies and highlighted the company’s comprehensive approach, which includes drugs targeting tau as well as treatments addressing severe behavioral symptoms like psychosis and agitation.

Preclinical studies showed that BMS-986446 significantly reduced tau uptake and spread, protected against behavioral deficits, and targeted tau pathology in Alzheimer’s brain tissue. The antibody was also well tolerated in a Phase 1 study involving healthy participants. The fully enrolled Phase 2 trial includes biomarkers of tau and amyloid-beta biology alongside clinical measures to assess the drug’s impact on disease progression.