Biogen:BIIB122 failed in Phase IIb clinical trial.

The Parkinson’s disease candidate drug from Biogen and Denali Therapeutics failed to significantly slow disease progression in a Phase IIb study, leading the partners to discontinue the drug.

BIIB122, also known as DNL151, is an oral small-molecule LRRK2 inhibitor. LRRK2 is a protein commonly found in the brain that helps with cellular structure formation. LRRK2 is also involved in signal transduction and other enzymatic functions. LRRK2 dysfunction has been linked to Parkinson’s disease.

The failed study was a Phase IIb clinical trial called LUMA. The trial enrolled nearly 650 patients with early-stage Parkinson’s disease and randomly assigned them to receive either the investigational drug BIIB122 or a placebo.

Last Thursday, Biogen and Denali announced that the drug did not significantly slow disease progression compared with placebo. BIIB122 also failed to meet key secondary endpoints, including measures of disability and impairment of activities of daily living.

Based on these results, Biogen and Denali stated that they would discontinue further development of BIIB122 in idiopathic Parkinson’s disease. Denali will continue to independently conduct the Phase IIa BEACON study evaluating the small-molecule inhibitor in carriers of pathogenic LRRK2 mutations.

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