Biogen announced this week its intentions to revise the clinical development program for BIIB122, developed in partnership with Denali Therapeutics for the treatment of Parkinson’s disease.
BIIB122, a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2), was evaluated in two global late-stage clinical trials: A phase 2b LUMA study for early-stage Parkinson's disease (which began in May 2022) and the phase 3 LIGHTHOUSE study for Parkinson's disease related to LRRK2 mutations (which began in September 2022).
But with an expected completion in 2031, Biogen and Denali have agreed to refocus their efforts. The revised plan, part of Biogen's R&D prioritization initiative and resource allocation, aims to obtain timely efficacy data in early-stage idiopathic Parkinson's disease while also gathering further clinical data in Parkinson's disease with and without LRRK2 mutations.
According to the companies’ recent statement, the LIGHTHOUSE study for BIIB122 in patients with Parkinson's disease associated with LRRK2 mutations will be terminated. and patients who are currently enrolled and randomized in the LIGHTHOUSE study will be offered the opportunity to participate in the LUMA study instead.