HEALEY ALS Platform Trial - Regimen G DNL343

Summary

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen G will evaluate the safety and efficacy of a single study drug, DNL343, in participants with ALS.

Timeline

Start

2023-05-24

Primary completion

2024-10-29

Completion

2024-10-29

Outcome

Missed primary endpoint

registry Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. (DNL343 slowed progression) was 0.3286. NCT05842941 ↗

release “primary endpoint was not met in Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343” denalitherapeutics.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EVETIFATOR	Small molecule	—	Oral

Indications