Clene has announced positive results from the HEALEY ALS Platform Trial, revealing that CNM-Au8 led to significant reductions in plasma neurofilament light chain concentrations in patients with amyotrophic lateral sclerosis (ALS). The company is considering filing a New Drug Application and preparing the complete CNM-Au8 clinical data package for regulatory discussions with the FDA. Developed using Clene's nanotherapeutic platform, CNM-Au8 is an oral suspension of gold nanocrystals that promotes remyelination and neuroprotective processes by catalyzing energy-producing reactions in neurons.
ALS, commonly known as Lou Gehrig’s disease, is a progressive neurological disorder that affects nerve cells in the brain and spinal cord. It leads to muscle weakness and wasting away, but currently there is no cure for ALS, and treatments only aim to relieve symptoms.
The promising biomarker data from Clene's trial indicates that CNM-Au8 could potentially be a disease-modifying treatment not just for ALS but also for other neurodegenerative diseases such as multiple sclerosis and Parkinson’s disease. This approach may signal a wider change