BIIB122 failed to slow early-stage Parkinson’s disease in the Phase 2b LUMA study, missing both its primary endpoint and all secondary endpoints versus placebo.
648 patients aged 30 to 80 were treated for at least 48 weeks and up to 144 weeks, but the LRRK2 inhibitor showed no clinical benefit despite expected drug exposure and an acceptable safety profile.
Biomarker data still showed more than 90% peripheral LRRK2 kinase inhibition and up to about 30% reduction in a cerebrospinal-fluid marker, suggesting target engagement without disease-modifying effect.
Biogen and Denali will stop development in idiopathic Parkinson’s disease, while Denali continues the Phase 2a BEACON study in patients carrying a pathogenic LRRK2 variant, with data due in the first half of 2027.
With one LRRK2 drug failing, could a new gene-silencing therapy for Parkinson's be the answer?
A Parkinson's drug hit its biological target perfectly, so why did it completely fail patients?