Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL201 for Parkinson’s Disease

Denali Therapeutics (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today announced initiation of dosing in a Phase 1b clinical study of DNL201 in patients with Parkinson’s disease.

As quoted in the press release:

“Based on the positive outcome of our Phase 1 study in 122 healthy volunteer subjects, we are excited to evaluate DNL201 in Parkinson’s disease patients,” said Carole Ho, M.D., Chief Medical Officer of Denali. “This study will provide additional important safety and biomarker data in patients to support rational dose selection. The results from this study will inform decisions on further clinical testing of DNL201, including potential registrational trials.”

DNL201, Denali’s lead LRRK2 therapeutic candidate, is a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2). LRRK2 is a regulator of lysosomal function, which is impaired in Parkinson’s disease and may be restored by LRRK2 inhibition. Inhibition of LRRK2 activity may potentially slow the progression of disease in patients with a genetic LRRK2 mutation as well as in patients with sporadic Parkinson’s disease.

Mutations in the LRRK2 gene are among the most frequent genetic causes of Parkinson’s disease and a major driver of lysosomal dysfunction, which contributes to the formation of Lewy body protein aggregates and neurodegeneration.

Click here to read the full press release.