DNL343 Falls Short of Primary End Point in Phase 2/3 HEALEY-ALS ...
Jan 7, 2025 · 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 ...
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.
ALS investigational therapies DNL343 and fosigotifator fail …
Jan 9, 2025 · 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.
Denali’s ALS Drug DNL343 Misses Key Trial Endpoint
Jan 7, 2025 · 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.
Denali Therapeutics Announces Topline Results for Regimen G …
Jan 6, 2025 · For the primary analysis, a total of 186 participants who were randomized to receive DNL343 treatment were compared to 139 participants randomized to receive placebo in this regimen (n=63) or ...
Denali Suffers Another ALS Fail With Phase II/III Flop
Jan 7, 2025 · Nearly a year after its previous stumble in amyotrophic lateral sclerosis, Denali Therapeutics on Monday announced that its small molecule drug candidate DNL343 missed its primary and key secondary endpoints in the Phase II/III HEALEY ALS platform study. The California biotech did not provide specific data in its news release, revealing only that DNL343 …
Denali Therapeutics’ trial of DNL343 fails to meet primary endpoint
Jan 7, 2025 · 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, …
AAN 2023: DNL343 is safe, appears to work as intended in Phase 1...
Apr 26, 2023 · The findings supported the launch of a Phase 1b study (NCT05006352) to test DNL343 in people with ALS, with the primary aim of assessing the safety and tolerability of the therapy. A total of 28 patients were randomly assigned to take a low or high dose of DNL343 or a placebo, either orally or via a feeding tube, daily for about a month.
Denali Therapeutics Announces New DNL343 (eIF2B Agonist)
Apr 10, 2023 · DNL343 is an investigational, small molecule eIF2B activator designed to cross the BBB with the potential of preventing or slowing ALS disease progression. The DNL343 abstract is available here...
Denali Therapeutics Announces DNL343 Interim Phase 1b Data in …
Dec 5, 2022 · By inhibiting the ISR pathway, DNL343 is intended to prevent or slow disease progression associated with stress granule formation and TDP-43 aggregation, a hallmark pathology present in nearly...
- Some results have been removed