Denali Therapeutics (DNLI) said Monday the phase 2/3 Healey-ALS platform trial of eIF2B activator DNL343 as a treatment for amyotrophic lateral sclerosis missed primary and secondary endpoints.
"The study did not meet the primary endpoint of efficacy in slowing disease progression as compared with placebo," the company said in a statement. "Key secondary endpoints, measuring muscle strength and respiratory function, were also not statistically different between the active and placebo groups at week 24."
"DNL343 was found to be safe and well tolerated," the company said.
The company said further evaluation will be conducted later this year, including neurofilament light and other fluid biomarkers, data from prespecified subgroups, as well as extended findings from the active treatment extension period.
Shares of the company fell 5.7% in after-hours activity.
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