Denali Therapeutics Misses Primary Endpoint in ALS Trial

By Tamara Parker • Tuesday, January 07 15:21 • Permanent Link

Denali Therapeutics Inc. has released its topline results for the regimen G phase 2/3 Healey ALS platform trial evaluating the eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis (ALS). The study did not meet the primary endpoint of efficacy in slowing disease progression compared with the placebo. The primary endpoint was measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) and survival through week 24. Key secondary endpoints, measuring muscle strength and respiratory function, were also not statistically different between the active and placebo groups at week 24.

For the primary analysis, a total of 186 participants who received DNL343 treatment were compared to 139 participants who received the placebo in this regimen. The market has reacted to these announcements by moving the company's shares 7.5% to a price of $21.32. For more information, read the company's full 8-K submission here.

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