Denali Therapeutics discontinues active treatment extension in eIF2B Regimen G

In an 8-K filing, the company states: “On March 5, 2025, Denali Therapeutics (DNLI) Inc. provided an update that further analyses from Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis did not demonstrate a treatment effect on neurofilament light (NfL), a biomarker of neuronal damage, over the 24-week, double-blind period and in a subset of participants that completed an additional 28 weeks in the open-label active treatment extension. On January 6, 2025, Denali announced that the study did not meet the primary endpoint of efficacy in slowing disease progression as compared with placebo. Key secondary endpoints were also not statistically different between the active and placebo groups at week 24. Based on these outcomes, the active treatment extension in Regimen G will be discontinued. Overall, DNL343 was found to be safe and well tolerated. Data from Regimen G will be presented at a future medical meeting. Denali intends to assess potential future development opportunities for DNL343.”