Clene Inc. and its wholly owned subsidiary Clene Nanomedicine Inc. announced the publication of a peer-reviewed article describing brain target engagement by CNM-Au8, the company's lead drug candidate. CNM-Au8 is an orally-delivered suspension of clean-surfaced, catalytically-active gold nanocrystals shown to have neuroprotective and neuroreparative properties in multiple preclinical models of neurodegenerative disease. The paper, entitled, " Evidence of Brain Target Engagement in Parkinson's Disease and Multiple Sclerosis by the Investigational Nanomedicine, CNM-Au8, in the REPAIR Phase 2 Clinical Trials," was published in the Journal of Nanobiotechnology, a Springer Nature journal that communicates significant advances in the fields of medicine and biology with an emphasis in their interface with nanoscale sciences.

Co-authored by physician scientists from the University of Texas Southwestern (UTSW) Medical Center and Clene, the publication describes results from two Phase 2a clinical trials, REPAIR-PD and REPAIR-MS. Key brain metabolites, such as NAD+ and NADH, that are involved in neuronal energy production, utilization, and maintenance, were measured for changes from baseline with daily, oral treatment of CNM-Au8 over 12 weeks. The studies' primary endpoint, the change in brain ratio of the metabolites NAD+ to NADH from baseline, was met with statistical significance (p < 0.05) by a demonstrated 10.4% increase. Statistically significant treatment effects were also observed for secondary and exploratory imaging outcomes, including favorable effects on brain ATP (adenosine triphosphate) levels and phosphorylation potential across both cohorts.