ALS investigational therapies DNL343 and fosigotifator fail …
1 day ago · In the fully enrolled DNL343 arm (NCT05842941), 186 participants were randomized to receive daily oral DNL343 and were compared to 139 people who received a placebo in this arm (63 patients) or a concurrent arm (76 patients). Disease progression wasn’t slowed with DNL343 relative to the placebo group, meaning the main goal wasn’t met.
Sean M. Healey & AMG Center Announces Topline Results in …
About DNL343 . DNL343 is a novel investigational ALS therapy that targets eIF2B, a central regulator of the integrated stress response (ISR). The ISR appears to be overactive in ALS, leading to the formation of stress granules containing TDP-43 1,2. Buildup of TDP-43 is harmful and leads to neuronal degeneration.
DNL343 Falls Short of Primary End Point in Phase 2/3 HEALEY-ALS ...
4 days ago · We remain deeply committed to fully understanding the effects of DNL343 in ALS and will further evaluate the data before determining next steps." REFERENCES 1. Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial. News release. January 6, 2025. Accessed January 7 ...
DNLI’s ALS Study Fails - Yahoo Finance
3 days ago · DNLI's DNL343 fails to achieve the primary and secondary endpoints, as observed from an analysis of Regimen G of the phase II/III HEALEY ALS platform trial. News Today's news
Novel small molecule for ALS fails to meet primary endpoint in
2 days ago · The study included 186 participants who received treatment with DNL343 and 139 participants given either placebo from regimen G (n = 63) or shared from a concurrently enrolling regimen within the ...
Denali’s ALS Drug DNL343 Misses Key Trial Endpoint
3 days ago · Understanding the Role of DNL343 and Macrocycles. DNL343 is a small molecule drug that acts as an agonist of eIF2B, which regulates the integrated stress response (ISR). The ISR has been reported to be overactive in patients with ALS, causing the accumulation of the TDP-43 protein, which is involved in the process of neuronal degeneration.
Rival AbbVie and Denali prospects flunk phase 2/3 ALS tests
4 days ago · The failure of fosigotifator and DNL343 may have implications for Bristol Myers Squibb, which paid Evotec a $20 million option fee to license a eIF2B candidate in 2021.
Denali Therapeutics’ trial of DNL343 fails to meet primary endpoint
4 days ago · DNL343 is an investigational candidate operated by targeting eukaryotic initiation factor 2B (eIF2B), a key regulator of the integrated stress response. This is considered a new small molecule therapeutic approach for treating ALS, …
Denali Therapeutics Announces Topline Results for Regimen G …
4 days ago · About DNL343. DNL343 is a novel small molecule ALS therapeutic candidate that targets eIF2B, a central regulator of the integrated stress response (ISR). The ISR appears to be overactive in ALS, leading to the formation of stress granules containing TDP-43.1,2 The buildup of TDP-43 is harmful and leads to neuronal degeneration.
AAN 2023: DNL343 is safe, appears to work as intended in Phase 1...
Apr 26, 2023 · “DNL343 is generally safe and well-tolerated at doses that demonstrate robust inhibition of ISR,” the researchers concluded, adding that these data “support further development of DNL343 as a potential therapeutic for the treatment of ALS.”
- Some results have been removed