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Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease
BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s diseasePhase 2b
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s diseasePhase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRRK2 inhibitor SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass., May 31, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), and Biogen Inc. (NASDAQ:BIIB) today announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 (DNL151), as compared to placebo in approximately 640 participants with early-stage Parkinson’s disease. LUMA is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of BIIB122 in people with early-stage Parkinson’s disease between the ages of 30 and 80. The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. Participants will be randomized to receive oral BIIB122 or placebo once daily. “More than 10 million people worldwide are affected by Parkinson’s disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease,” said Carole Ho, M.D., Chief Medical Officer at Denali. “Initiation of the LUMA study marks an important milestone in the development of BIIB122 as a potentially first-in-class oral LRRK2 therapy for Parkinson’s disease. We look forward to continuing our collaboration with Biogen and the Parkinson’s community in our unified goal to develop BIIB122 as a potential treatment option for people and families living with Parkinson’s disease.” BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali. Denali and Biogen are co-developing and co-commercializing BIIB122 for the potential treatment of Parkinson’s disease. The BIIB122 clinical development program includes both the LUMA Phase 2b study and the Phase 3 LIGHTHOUSE study in individuals with Parkinson’s disease with LRRK2 pathogenic variants. “Inhibition of LRRK2 is a novel approach designed to target an underlying biological pathway implicated in Parkinson’s disease,” said Samantha Budd Hae...