Bristol Myers Squibb Says FDA Grants Fast Track Status To BMS-986446 For Alzheimer's Treatment

(RTTNews) - 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.