Denali Therapeutics Inc. announced the initiation of dosing in a global Phase 2a clinical study, BEACON, for its investigational drug BIIB122 (DNL151). This study targets leucine-rich repeat kinase 2 (LRRK2) inhibition in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD).
The Phase 2a BEACON study is designed to evaluate the safety and biomarkers associated with oral daily dosing of BIIB122. Approximately 50 participants with Parkinson’s disease and confirmed LRRK2 pathogenic mutations will be enrolled in the study, which includes a three-month double-blind treatment period followed by an open-label extension.
BIIB122 is a selective, central nervous system-penetrant small molecule inhibitor of LRRK2, hypothesized to improve lysosomal dysfunction implicated in Parkinson’s disease. Denali is leading the design and execution of this Phase 2a study, while its strategic partner Biogen is conducting the global Phase 2b LUMA study for BIIB122 in early-stage Parkinson’s disease.
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