Denali and Biogen revise BIIB122 program; close Phase 3 LIGHTHOUSE, expand Phase 2b LUMA

Denali Therapeutics Inc.

Denali (DNLI) and Biogen (BIIB) plan to close the Phase 3 LIGHTHOUSE study of BIIB122 in LRRK2-mutation Parkinson's, expected completion 2031; enrolled patients may join LUMA.
The Phase 2b LUMA study will be modified to include both idiopathic early-stage PD and LRRK2-mutation patients; total enrollment ~640 participants.
This revision is not based on any safety or efficacy data from BIIB122 studies.
LUMA is designed to support registration; Biogen will operationalize the study.
The change aims to get an efficacy readout sooner in idiopathic PD and initial data in LRRK2-mutation PD.

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