Biogen And Denali Stop BIIB122 Development After Phase 2b Parkinson's Trial Shows No Benefit

(RTTNews) - Biogen Inc. (BIIB) and Denali Therapeutics Inc. (DNLI) reported results from the Phase 2b LUMA study evaluating BIIB122 (DNL151), a small molecule inhibitor of LRRK2 in early-stage Parkinson's disease. The study found that BIIB122 did not slow disease progression compared to placebo, as measured by the primary endpoint (Time to Confirmed Worsening in MDS-UPDRS Part II & III combined score). Secondary endpoints also showed no benefit.

Exploratory biomarker data confirmed >90% peripheral LRRK2 kinase inhibition, and cerebrospinal fluid analysis showed up to 30% reduction in phosphorylated Rab10, a marker of LRRK2 activity. Drug levels in blood and CSF were sustained, and BIIB122 was generally well tolerated with an acceptable safety profile.

Based on these findings, Biogen and Denali will discontinue further development of BIIB122 in idiopathic Parkinson's disease. Denali will continue independently with the Phase 2a BEACON study, focusing on carriers of pathogenic LRRK2 variants.

DNLI closed regular trading at $19.30 on May 21, rising $0.47 or 2.50%. However, in overnight trading at 1:16:11 AM EDT, the stock fell sharply to $17.79, a decline of $1.51 or 7.82% from the close.

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