BRIEF—Biogen to revise program for PD drug BIIB122

US biotech major Biogen announced plans to revise the clinical development program for BIIB122, a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2), which is being developed in collaboration with Denali Therapeutics.

Prior to the planned revisions, the BIIB122 clinical development program encompassed two global late-stage clinical trials: the Phase IIb LUMA study in participants with early-stage Parkinson’s disease, which commenced in May 2022; and the Phase III LIGHTHOUSE study in participants with Parkinson’s disease related to LRRK2 mutations, which commenced in September 2022.

In consideration of the LIGHTHOUSE study’s complexity including the long timeline with anticipated study completion in 2031, Biogen and Denali have agreed that efforts will be refocused to enable a timely readout on efficacy in early-stage idiopathic Parkinson's disease while gaining further clinical data in Parkinson’s disease with and without a LRRK2 mutation.