Denali-Biogen Parkinson's Disease Candidate Shows Reductions In Biomarkers; Late Study To Begin By 2021 End

Denali Therapeutics Inc DNLI has announced final results from Phase 1 and Phase 1b studies evaluating BIIB122/DNL151 Parkinson's disease. The drug is being developed in collaboration with Biogen Inc BIIB.
The results will be presented at the International Association of Parkinsonism and Related Disorders Virtual Congress.
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 the urine of the lysosomal lipid BMP, a biomarker of lysosomal function, was achieved with BIIB122/DNL151 treatment.
BIIB122/DNL151 was generally well tolerated across a broad range of doses for up to 28 days, the longest treatment duration in both studies.
In Phase 1 and Phase 1b studies, a dose-dependent reduction in pS935 of more than 50% in whole blood was observed at doses of BIIB122/DNL151 greater than 70 mg in healthy volunteers and across all dose levels studied in patients (80 mg, 130 mg, and 300 mg given once daily for 28 days).
A robust reduction in pS935 greater than or equal to 80% was observed at doses of BIIB2122/DNL151 greater than or equal to 225 mg across both studies.
The companies plan to advance BIIB122/DNL151 into late-stage clinical development in Parkinson's disease by year-end 2021.
Price Action: DNLI shares closed 1.4% lower at $60.44, while BIIB shares closed 0.7% higher at $267.33 on Friday.