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

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  • Denali Therapeutics Inc (NASDAQ: 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 (NASDAQ: 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.

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