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As previously announced, the Phase 1b study is a multicenter, randomized, placebo-controlled, double-blind, 28-day study followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of DNL343 in participants with ALS

Denali Therapeutics Announces DNL343 Interim Phase 1b Data in ALS andEntry into the HEALEY ALS ...

Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases and lysosomal storage disorders, today announced interim results from a Phase 1b study of its eIF2B agonist, DNL343, in participants with amyotrophic lateral sclerosis (ALS)

By Denali Therapeutics Inc.
Published - Dec 05, 2022, 07:07 AM ET
Last Updated - Apr 04, 2024, 10:55 AM EDT
  •  DNL343 demonstrated extensive blood-brain barrier penetration and robustly inhibited the integrated stress response pathway implicated in ALS
  • Once-daily oral dosing with DNL343 for 28 days was generally well tolerated in participants with ALS
  • The design phase for entry of DNL343 into a Phase 2/3 trial in the HEALEY ALS Platform Trial is underway
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