NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb (BMY) announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody currently in Phase 2 development for the treatment of early Alzheimer's disease.
The FDA's Fast Track Designation for BMS-986446 underscores the urgent need for innovative therapies for Alzheimer's disease and recognizes the potential of this investigational anti-MTBR-tau antibody to meaningfully alter the trajectory of disease progression
Alzheimer's disease, the most common type of dementia in adults, is a progressive, multifaceted and devastating neurodegenerative disease in which significant changes occur in the brain that cause neurons to die over time.
BMS-986446 aims to modify the underlying course of the disease with the ultimate goal of slowing or delaying disease progression.
In preclinical models, BMS-986446 demonstrated significant reductions in tau uptake and spread, protection against behavioral deficits and was localized with tau pathology in Alzheimer's brain tissue.
BMS-986446 was also shown to be safe and well tolerated across three dose cohorts in a Phase 1 study of healthy participants.
The ongoing Phase 2 study is fully enrolled and includes several biomarkers of tau and amyloid-beta biology, as well as clinical outcome measures, to evaluate the impact of BMS-986446 on disease progression.
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