Latest ALS Clinical Trial Information

CNM-Au8

Action: Promotes cellular energy generation and eliminates oxidative stress.

Current status of clinical trial: Phase II electrophysiological evaluation showed reduced progression; ALSFRS-R was suppressed by a 6-point decline.

Details

Action: Oral suspension of gold nanocrystals (13 nm in diameter). The surface catalyzes energy-generating reactions (increases in NAD+ and ATP) and eliminates oxidative stress.

Current status of the study: Phase 2, randomized, double-blind, placebo-controlled trial (23 actives, 22 placeboes): The primary endpoint of ALSFRS-R and secondary endpoints of Combined Assessment of Function and Survival (CAFS) and slow vital capacity (SVC) were not met at 24 weeks. However, in an exploratory analysis of a long-term open-label extension study (OLE), survival data showed a 62% reduction in the risk of death compared to that in the no treatment or delayed treatment groups (first randomized to placebo) (HR 0.291; p=0.015).

Dosage: Oral administration