BMS-986446 receives FDA fast track designation for alzheimer's treatment

The U.S. Food and Drug Administration has granted Fast Track Designation to BMS-986446, an anti-microtubule binding region-tau antibody being developed by Bristol Myers Squibb for early Alzheimer's disease treatment, according to Prothena Corporation plc (NASDAQ: PRTA).

Fast Track Designation is intended to facilitate development and expedite review of investigational drugs that treat serious conditions and fill unmet medical needs. BMS-986446, also known as PRX005, is currently in Phase 2 development as a potential disease-modifying therapy to slow or delay progression of Alzheimer's disease.

The antibody targets pathological tau protein fragments containing the microtubule binding region, which appear to have a key role in Alzheimer's disease pathology. By neutralizing the spread and promoting clearance of pathological tau, BMS-986446 aims to modify the underlying course of the disease.

In preclinical models, BMS-986446 demonstrated reductions in tau uptake and spread, protection against behavioral deficits, and was localized with tau pathology in Alzheimer's brain tissue. The drug was shown to be safe and well tolerated across three dose cohorts in a Phase 1 study of healthy participants.

Bristol Myers Squibb announced that the ongoing Phase 2 study is fully enrolled and includes biomarkers of tau and amyloid-beta biology, as well as clinical outcome measures, to evaluate the impact of BMS-986446 on disease progression.

Under the global license agreement with Bristol Myers Squibb, Prothena is eligible to receive regulatory and sales milestone payments of up to $562.5 million, plus tiered royalties on net sales. Bristol Myers Squibb is responsible for all communication, development, manufacturing, and commercialization of BMS-986446.

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