Anti-MTBR-Tau-Targeting Antibody Fast Tracked for Early Alzheimer Disease

The Food and Drug Administration (FDA) has granted Fast Track designation to Bristol Myers Squibb’s anti-microtubule binding region-tau (anti-MTBR-tau) antibody (BMS-986446) for the treatment of early Alzheimer disease.

The investigational agent is a humanized monoclonal antibody that targets multiple domains of the microtubule binding region of tau. By binding to these specific regions, BMS-986446 is expected to prevent the spread of pathological tau and promote its clearance via phagocytosis.

The Fast Track designation was supported by preclinical data that showed the  anti-MTBR-tau-targeting antibody reduced tau uptake and spread and protected against neurotoxicity. Results from a phase 1 trial in healthy participants (ClinicalTrials.gov Identifier: NCT06955741) showed the treatment was safe and well tolerated.

BMS-986446 is currently being investigated in a randomized, double-blind, placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT06268886) in patients with early Alzheimer disease. According to BMS, the study is fully enrolled and will evaluate several biomarkers of tau and amyloid-beta biology, in addition to clinical outcomes. The primary endpoint of the study is the change from baseline in brain tau deposition as measured by tau positron emission tomography at week 76. 

“The FDA’s Fast Track designation for BMS-986446 underscores the urgent need for innovative therapies for Alzheimer disease and recognizes the potential of this investigational anti-MTBR-tau antibody to meaningfully alter the trajectory of disease progression,” said Laura Gault, senior vice president, head of development, Neuroscience, Bristol Myers Squibb. 

This article originally appeared on MPR