Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for Alzheimer’s Disease

Denali Therapeutics (NASDAQ: DNLI) has announced the initiation of dosing in a Phase 1b clinical study of DNL747 in patients with Alzheimer’s disease with its partner Sanofi.

As quoted in the press release:

“We are excited to advance DNL747 in a second neurodegeneration indication based on Phase 1 healthy volunteer data regarding DNL747’s safety profile, CNS penetration, and target engagement, at the studied doses.” said Carole Ho, M.D., Chief Medical Officer of Denali. “Similar to our previously announced Phase 1b study in ALS, the primary purpose of this Phase 1b study is to gain additional safety and biomarker data in patients with Alzheimer’s disease to support dose selection. The results from this study will inform our decisions on future clinical studies in Alzheimer’s disease.”

RIPK1, receptor-interacting serine/threonine-protein kinase 1, is a critical signaling protein in the TNF receptor pathway, which regulates inflammation and cell death in tissues throughout the body. Denali, together with its partner Sanofi, is investigating several molecules targeting RIPK1 for multiple indications, including DNL747 for Alzheimer’s disease, ALS, and Multiple Sclerosis. In January 2019, Denali announced the initiation of dosing in a Phase 1b clinical study of DNL747 in patients with ALS.

About the DNL747 Phase 1b study in Alzheimer’s disease

This study (NCT03757325) is a 28-day, randomized, double-blind, placebo-controlled crossover design Phase 1b clinical trial in patients with Alzheimer’s disease. Its purpose is to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and target and pathway engagement biomarkers in the CSF and blood for oral doses of DNL747. Up to 26 patients in the study will be randomized to receive either DNL747 or placebo in a crossover design study.

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