An investigatational antibody therapy gained a second life on 2 February, nearly three years after Prothena Corporation plc gave up on it. The Dublin-based firm announced plans for a confirmatory Phase III trial of birtamimab in amyloid light-chain (AL) amyloidosis patients facing high risk of early mortality, which it intends to start in mid-2021 and hopes to produce event-based data during the first half of 2024.
Prothena Gives Amyloidosis Drug Birtamimab A Second Chance
With post hoc analysis from a 2018 study showing a survival benefit in patients at high risk for early mortality, Prothena negotiated a path forward with the US FDA for approval in AL amyloidosis.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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