Prothena Stock Tumbles as Phase 3 Study on Birtamimab Fails

Published 10 hours agoPRTA

Prothena Stock Tumbles as Phase 3 Study on Birtamimab Fails

Prothena Corporation faced a major setback as its stock plummeted by roughly 63% following the unsuccessful results of its Phase 3 VITAL Amyloidosis Study. The trial, assessing the efficacy of birtamimab (NEOD001) for treating AL amyloidosis, was terminated early in 2018 due to a futility analysis indicating it would not meet its primary goals, according to Gen Eng News.

The final results from the study showed a hazard ratio of 0.835 for the combined primary endpoint, which included metrics such as time to all-cause mortality or cardiac hospitalization. This ratio, with a 95% confidence interval ranging from 0.5799 to 1.2011 and a p-value of 0.3300, verified the earlier futility analysis, as reported by GlobeNewswire. Additionally, none of the secondary endpoints reached statistical significance across the study population, further underscoring the trial's disappointing findings.

Despite these outcomes, a post hoc analysis indicated a potential survival advantage for patients with Mayo Stage IV AL amyloidosis, showing a hazard ratio of 0.544. However, this was not statistically significant. These results raise important questions regarding the future prospects of birtamimab as an effective treatment avenue for AL amyloidosis, leaving Prothena to reassess its strategic direction.

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