Clinical TrialMay 21, 2026, 06:02 PM
Denali & Biogen Discontinue BIIB122 in Parkinson's After Phase 2b Failure
AI Summary
Biogen and Denali Therapeutics announced that their Phase 2b LUMA study evaluating BIIB122 (DNL151) in early-stage Parkinson's disease failed to meet its primary or secondary endpoints. As a result, the companies will discontinue further development of BIIB122 for idiopathic Parkinson's disease. Despite the clinical outcome, exploratory biomarker endpoints demonstrated significant LRRK2 kinase inhibition, and the drug was generally well tolerated. Denali will independently continue the Phase 2a BEACON study for BIIB122 in individuals with Parkinson's disease who are carriers of a pathogenic LRRK2 variant, with data expected in the first half of 2027.
Key Highlights
- Phase 2b LUMA study of BIIB122 in early-stage Parkinson's disease did not meet primary or secondary endpoints.
- Biogen and Denali will discontinue development of BIIB122 in idiopathic Parkinson's disease.
- Exploratory biomarker endpoints showed >90% kinase inhibition of peripheral LRRK2.
- CSF sub-study observed up to 30% reduction in phosphorylated Rab10.
- BIIB122 was generally well tolerated with an acceptable safety profile.
- Denali continues Phase 2a BEACON study in carriers of a pathogenic LRRK2 variant.
- LUMA study enrolled 648 participants aged 30-80.
- BEACON study data is anticipated in the first half of 2027.
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