Denali Therapeutics‘ oral candidate DNL343 has failed to reduce levels of an established biomarker of nerve cell damage in adults with amyotrophic lateral sclerosis (ALS). That’s according to new data from the DNL343 arm of the HEALEY ALS platform trial (NCT04297683), where patients who received the experimental…

The investigational oral therapies DNL343 and fosigotifator didn’t significantly slow disease progression in people with amyotrophic lateral sclerosis (ALS) compared with a placebo, and therefore failed to meet the main goal of their respective arms in the HEALEY platform trial. While they were found to be safe and well…

Patient enrollment is now complete in an arm of the HEALEY ALS platform trial that’s testing Denali Therapeutics‘ DNL343 for the treatment of adults with amyotrophic lateral sclerosis (ALS). The HEALEY platform trial (NCT04297683), led by the Sean M. Healey & AMG Center…

Treatment with the investigational therapy DNL343 was generally well-tolerated among people with amyotrophic lateral sclerosis (ALS) in an early clinical trial, and biomarker data from the trial suggest that the therapy is working as intended. Results were presented at the annual meeting of the American Academy of Neurology (AAN),…

DNL343, an investigational oral small molecule developed by Denali Therapeutics, can extensively enter the brain and reduce the cellular stress response that contributes to amyotrophic lateral sclerosis (ALS) progression. That’s according to an interim analysis of data from a Phase 1b clinical trial (NCT05006352), in which DNL343 was…

Early trials in healthy adults supported the safety and tolerability of two potential oral therapies for amyotrophic lateral sclerosis (ALS) — DNL343 to prevent the cellular stress that can promote toxic protein granules, and DNL788 to block a protein linked to brain inflammation — Denali Therapeutics reported. A Phase…

A Phase 1b clinical trial evaluating the safety and pharmacological profile of DNL343, Denali Therapeutics’ investigational oral therapy, in adults with amyotrophic lateral sclerosis (ALS) has started dosing participants. The study (NCT05006352) is currently recruiting patients at the Centre for Human Drug Research (CHDR) in Leiden, Netherlands.