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Tuesday, July 16, 2019

Mallinckrodt bails on mid-stage study of Acthar Gel in Lou Gehrig’s disease

Citing safety concerns, Mallinckrodt (NYSE:MNKterminates its Phase 2b clinical trial, PENNANT, evaluating Acthar Gel (repository corticotropin injection) in patients with amyotrophic lateral sclerosis (ALS). The specific issue was a higher-than-expected rate of pneumonia in the treatment group compared to the placebo group.
Another factor was the lack of a clear efficacy signal. The independent Data and Safety Monitoring Board noted that there was not a great enough proportion of subjects who completed week 36 to provide a definitive determination of a treatment effect.

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