Clene Inc.’s (NASDAQ: CLNN) Phase 2 REPAIR-PD and REPAIR-MD Trials Indicate CNM-Au8(R)’s Ability to Increase Key Brain Metabolites, Supporting Advancement to Phase 3 Trials

• Clene Inc., a late clinical-stage biopharmaceutical company focused on developing solutions that improve mitochondrial health and protect neuronal function to treat neurodegenerative diseases, recently announced the publication of a peer-reviewed article
• The article describes results from two Phase 2a clinical trials, REPAIR-PD and REPAIR-MS, which evaluated the effects of CNM-Au8, the company’s lead drug candidate, on brain energy metabolite levels in participants with Parkinson’s Disease and Multiple Sclerosis, respectively
• Researchers measured key brain metabolites, such as NADH and NAD+, which are involved in neuronal energy production, utilization, and maintenance, for changes from baseline with daily, oral treatment of CNM-Au8 over 12 weeks
• Results from the studies showed that treatment with CNM-Au8 increased the brain NAD+/NADH ratio by a statistically significant (p < 0.05) 10.4%

Energy metabolism involves the conversion of the potential energy contained in food-borne fuels, including some amino acids, glucose, lactate, fatty acids, and ethanol, among others, into chemical energy. Usually, this chemical energy exists in the form of adenosine triphosphate (“ATP”), the universal energy-containing molecule that powers most cellular functions, including brain function.

ATP is produced through oxidative phosphorylation (“OXPHOS”) or glycolysis. The former, however, requires mitochondria and yields considerably more ATP than the latter (https://ibn.fm/9pQ6P). Unfortunately, oxidative phosphorylation can sometimes become impaired, affecting skeletal muscle, cardiac, and nervous tissues normally characterized by high energy metabolism. Causes of the impairments to oxidative phosphorylation vary from genetic defects and advanced age to human diseases.

Advanced age, for example, which is a known risk factor for most neurodegenerative diseases, “is associated with compromised energy metabolism, such as decreased glucose uptake and decreased mitochondrial electron transport chain activity, leading to lower ATP availability in the brain,” explains a 2023 peer-revied article published in the Journal of Nanobiotechnology. “These metabolic impairments are compounded in neurodegenerative disease… In neurodegenerative disease, a vicious cycle occurs in which energetic deficits exacerbate oxidative, proteostatic, and neuroinflammatory stressors, which in turn lead to further energetic impairment and neurodegeneration.”

The peer-reviewed article, 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 co-authored by physician scientists from the University of Texas Southwestern (“UTSW”) Medical Center and Clene. It describes results from two Phase 2a clinical trials, REPAIR-PD and REPAIR-MS, which evaluated the effects of CNM-Au8, the lead drug candidate developed by Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc, on brain energy metabolite levels in participants with diagnoses of idiopathic Parkinson’s Disease (“PD”) or relapsing Multiple Sclerosis, respectively, according to a December 14 article announcing its publication (https://ibn.fm/r5hxW).

CNM-Au8 is a suspension of faceted, clean-surfaced gold nanocrystals that have neuroprotective and neuroreparative properties thanks to their ability to catalytically improve energetic metabolism in central nervous system (“CNS”) cells. In vitro studies have shown that the surfaces of the CNM-Au8 nanocrystals catalyze the rapid oxidation of NADH to NAD+, increasing the intracellular availability of both NAD+ and ATP. (NAD+ supports the synthesis of ATP.)

The REPAIR-PD and REPAIR-MS Phase 2 trials, therefore, expand the documented evidence of CNM-Au8’s positive effects. In conducting the studies, researchers measured key brain metabolites, such as NADH and NAD+, which are involved in neuronal energy production, utilization, and maintenance, for changes from baseline with daily oral treatment of CNM-Au8 over 12 weeks. The studies’ primary endpoint was the change in the ratio of the brain metabolites NAD+ and NADH from baseline.

Treatment with CNM-Au8, the studies showed, resulted in a statistically significant (p < 0.05) 10.4% increase in the brain NAD+/NADH ratio. Additionally, the researchers observed statistically significant treatment effects for secondary and exploratory imaging outcomes, including favorable effects on brain ATP levels and phosphorylation potential across both cohorts. The results support the further investigation of CNM-Au8 as a potential disease-modifying drug for PD and MS in Phase 3 trials.

“We believe the 10.4% increase in brain NAD+/NADH ratio to be clinically significant. Other groups have shown significant deficits in brain energy metabolites associated with neurodegenerative disease,” Dr. Benjamin Greenberg, Head of Medical at Clene, commented. “For example, brain levels of NAD are deficient in Parkinson’s disease, and deficits in brain ATP levels correlate with the Expanded Disability Status clinical scale for multiple sclerosis. Even in healthy aging, the human brain’s NAD+/NADH decreases at a rate of loss of approximately half a percent per decade. Elevation of brain NAD+/NADH levels to many times the rate of loss observed in healthy aging is a significant and very promising effect.”

The article is available via Open Access at: https://ibn.fm/b2oo0

Clene and its wholly owned subsidiary Clene Nanomedicine Inc. is a late clinical-stage biopharmaceutical company intent on developing solutions that improve mitochondrial health and protect neuronal function to treat such neurodegenerative diseases as PD, multiple sclerosis, and amyotrophic lateral sclerosis (“ALS”).

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

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