Prothena says partner Bristol Myers Squibb’ BMS-986446 granted FDA fast-track

Prothena (PRTA) “announced that Bristol Myers Squibb (BMY) communicated in a press release that the U.S. Food and Drug Administration 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. Fast Track Designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and fill an unmet medical need. 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. Bristol Myers Squibb also announced that 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. As part of the BMS-986446 global license with Bristol Myers Squibb, Prothena is eligible to receive additional regulatory and sales milestone payments of up to $562.5 million. Prothena also is eligible to receive tiered royalties on net sales. Bristol Myers Squibb is responsible for all communication, development, manufacturing, and commercialization for BMS-986446.”