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Prothena Gives Amyloidosis Drug Birtamimab A Second Chance

 
• By Joseph Haas

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.

new growth in tree trunk
Prothena found a new way forward for birtamimab with a deep dive into Phase III VITAL

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.

Although Prothena ceased development of birtamimab in April 2018 following failure of the 260-patient, Phase III VITAL study in AL amyloidosis patients with cardiac involvement, a post hoc analysis of roughly one-third of the patients (n=77) who were categorized as Mayo Stage IV at baseline showed a statistically significant survival benefit compared to placebo. VITAL compared birtamimab plus standard of care (which included first-line Velcade (bortezomib)) against placebo plus standard of care

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