(News Bulletin 247) – Biogen today announced its intention to revise the clinical development program for BIIB122, a small molecule leucine-rich repeat kinase 2 (LRRK2) inhibitor, developed in collaboration with Denali Therapeutics.
Prior to planned revisions, the BIIB122 program included two late-stage trials: the Phase 2b LUMA study in participants with early-stage Parkinson’s disease; and the Phase 3 LIGHTHOUSE study in participants with Parkinson’s disease linked to LRRK2 mutations.
Given the complexity of the LIGHTHOUSE study, and its very long timeline with an expected end of study in 2031, Biogen and Denali have agreed to refocus their efforts to allow a rapid readout of efficacy in Parkinson’s disease idiopathic at an early stage.
The protocol for the LUMA study in patients with early-stage Parkinson’s disease will be modified to now include eligible patients with an LRRK2 gene mutation, while continuing to enroll eligible patients with idiopathic Parkinson’s disease at an early stage. The LIGHTHOUSE study will be discontinued.
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