Clene Inc

Clene Inc. announces preclinical data showing CNM-Au8 enhances cellular health in Parkinson’s disease models, supporting further clinical development

Clene Inc. announced promising preclinical data demonstrating that its investigational therapy, CNM-Au8, enhances cellular health in a novel model of Parkinson's disease (PD).

The study, presented at the Michael J. Fox Foundation H2 Therapeutics Stewardship Meeting, showed that CNM-Au8 improved mitochondrial health, restored cellular metabolism, reduced inflammation, and normalized gene expression in both familial and sporadic PD neurons.

Key findings included increased mitochondrial function and decreased reactive oxygen species in familial PD cells, lower levels of inflammatory proteins in sporadic PD cells, and a significant correction of metabolic imbalances. The research involved skin cells from PD patients converted into dopaminergic neurons, allowing for a realistic study of disease processes.

The study used skin cells from 8 sporadic PD (sPD) patients, 14 familial PD (fPD) patients—13 with LRRK2 gene mutations and 1 with a PARK gene mutation—and 13 healthy individuals. The skin cells were directly converted into dopaminergic neurons, the brain cells essential for movement and the most vulnerable to degeneration in PD. This innovative method retains age-related characteristics from PD patient donors, enabling researchers to study disease processes as they occur in aged disease-relevant neurons.

CNM-Au8 has previously shown favorable results in a Phase 2 study pertaining to brain energy metabolites in PD patients. Clene plans to further develop CNM-Au8 for PD alongside ongoing studies for other neurodegenerative disorders.

About CNM-Au8®

CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.