Benzinga | Sep 17, 2021 07:06AM EDT

Clene Highlights Presentation Of Phase 2 CNM-Au8 Target Engagement Data At Int'l. Parkinson, Movement Disorder Society Congress

CNM-Au8(r) , a catalytically active gold nanocrystal suspension, significantly improved brain energetic metabolism in Parkinson's patients

SALT LAKE CITY, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to the treatment of neurodegenerative disease using nanotechnology to treat energetic failure, today announced a poster presentation titled "Homeostatic Improvement of Brain Bioenergetic Metabolism in Parkinson's Disease: Results From A Phase 2 REPAIR-PD Clinical Trial With CNM-Au8" at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021 which takes place September 17 -- 22, 2021. The poster presentation is available for view here.

Clene's Phase 2 REPAIR program achieved a statistically significant increase in its primary endpoint, the mean change in brain NAD+/NADH ratio (p=0.037). NAD is an essential molecule responsible for cellular energy production. While the NAD+/NADH ratio declines normally during aging by approximately 0.5% per decade, reduced NAD+/NADH ratios have been reported in multiple neurodegenerative diseases, and the decline in the ratio is implicated in Parkinson's disease. In the REPAIR-PD study, the trend in NAD+/NADH ratio improvement was driven by both increased NAD+ and decreased NADH. Patients were evaluated using an innovative non-invasive brain imaging technique, phosphorous magnetic resonance spectroscopy, before and after 12 or more weeks of daily oral dosing with CNM-Au8. End of treatment results were compared to baseline. Exploratory endpoints revealed that taking CNM-Au8 resulted in the normalization of several critical markers of brain energy production capacity including beta-ATP levels and phosphorylation potential. There were no serious adverse events and treatment-emergent adverse events were mild and transient.

Robert Glanzman, MD FAAN, Clene's Chief Medical Officer, commented, "We are very pleased to share our results with the Parkinson's treatment community at the MDS Virtual Congress. We see CNM-Au8's impact on brain bioenergetics as a breakthrough in the way Parkinson's will be treated. The 10% increase in the NAD+/NADH ratio seen in our Phase 2 REPAIR Program corresponds to a reversal of approximately 20 decades of normal aging based on an anticipated decline of 0.5% per decade, a significant result."

Rob Etherington, Clene's Chief Executive Officer, added, "In addition to achieving its primary endpoint, the RESCUE-PD study reinforced our lead candidate CNM-Au8's central nervous system target engagement, as well as its ability to significantly rebalance brain metabolites, both of which have implications across most neurodegenerative diseases."

Approximately 7 million people are living with Parkinson's disease, the second most common neurogenerative disorder. Only symptomatic treatments are currently available in a market projected to reach $6 billion by 2025.

The International Parkinson and Movement Disorder Society (MDS) is a professional society of more than 11,000 clinicians, scientists and other healthcare professionals dedicated to improving the care of patients with movement disorders through education and research.