- Denali Therapeutics (NASDAQ:DNLI) announces final results from Phase 1 and 1b studies of its small molecule LRRK2 inhibitor, BIIB122/DNL151, which is being developed in collaboration with Biogen (NASDAQ:BIIB) as a potential treatment of Parkinson’s disease.
- Safety and biomarker goals were met in both studies, supporting plans to advance BIIB122/DNL151 into late-stage clinical development in Parkinson’s disease by year-end.
- Results from the Phase 1 study of healthy volunteers (N=184) and the Phase 1b study of patients with Parkinson’s disease (N=36) showed achievement of robust target and pathway engagement with BIIB122/DNL151 treatment as measured by pS935 LRRK2 and pT73 Rab10 (pRab10), respectively.
- In addition, a dose-dependent reduction in urine of the lysosomal lipid BMP, a biomarker of lysosomal function, was achieved with BIIB122/DNL151 treatment, providing peripheral evidence supporting improvement of lysosomal function.
- BIIB122/DNL151 was generally well tolerated across a broad range of doses for up to 28 days.
- BIIB122/DNL151 was generally well tolerated in healthy volunteers and patients with Parkinson’s disease. No serious adverse events were observed.
- The results will be presented at the International Association of Parkinsonism and Related Disorders Virtual Congress, being held May 1-4.