SALT LAKE CITY, Oct. 24, 2019 /PRNewswire/ -- Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the presentation of new preclinical neuroprotection data in multiple Parkinson's disease models at the 2019 Society for Neuroscience (SfN) Annual Meeting.
Clene's Head of Translational Medicine, Dr. Karen Ho, presented the data during a poster presentation, demonstrating that treatment of neuronal cultures with CNM-Au8 improved survival of dopaminergic neurons, protected neurite networks, decreased intracellular levels of reactive oxygen species, and improved mitochondrial capacity in response to disease-relevant neurotoxins. Oral treatment with CNM-Au8 restored functional behaviors in a rodent model of Parkinson's disease.
"We are excited to share these latest Parkinson's disease neuroprotection data regarding our lead nanocatalyst, CNM-Au8, with the neuroscience research community. Coupled with prior neuroprotection and remyelination data presented at major scientific congresses, this new Parkinson's data demonstrate how improvements in bioenergetics with CNM-Au8 may preserve neuronal viability across multiple neurodegenerative disorders," said Rob Etherington, President and CEO of Clene. "These data support our belief that treatment with CNM-Au8 may improve the survival of dopaminergic neurons in patients with PD, thereby helping slow the progression of this devastating disease. Disease modifying therapies remain a key, unmet treatment goal in Parkinson's disease," he stated.
"There is a critical unmet need for Parkinson's disease therapies that can protect dopaminergic neurons from further damage," said Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer. "We are excited to be advancing CNM-Au8 into studies in Parkinson's patients starting with the REPAIR-PD Phase 2 study—currently initiating at UT Southwestern. This study will advance our understanding how CNM-Au8 treatment affects central nervous system biomarkers related to bioenergetics, neuronal metabolism, and oxidative stress, as potential indicators of target engagement for CNM-Au8," he concluded.
CNM-Au8 is a concentrated, aqueous suspension of clean-surfaced faceted nanocrystalline gold (Au) that acts catalytically to support various intracellular biological reactions. CNM-Au8 consists solely of gold atoms organized into faceted, geometrical crystals held in suspension in sodium bicarbonate buffered, pharmaceutical grade water. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and both remyelination and neuroprotection effects in multiple preclinical studies. Preclinical studies of CNM-Au8 demonstrated that the drug protects motor neurons from death through a novel nanocatalytic mechanism, increasing the body's ability to resist several stressors associated with this disease. CNM-Au8 has received regulatory approval to proceed to clinical studies for the treatment of multiple sclerosis remyelination failure and neuroprotection of amyotrophic lateral sclerosis (ALS) and Parkinson's disease.
About Parkinson's Disease
Parkinson's disease, a progressive central nervous system disorder, is the second most common neurodegenerative disorder, affecting approximately 1.2% of the world population over the age of 70. PD predominately affects dopaminergic neurons—the neurons in the brain that make dopamine. Loss or impairment of dopaminergic neurons results in tremor, slowness, stiffness, difficulty walking, and balance problems. PD may also be associated with non-movement related symptoms, such as constipation, depression, and memory problems.
The objective of the REPAIR-PD Phase 2 study is to demonstrate improvements in central nervous system redox potential in Parkinson's disease patients treated with CNM-Au8. Participants will undergo repeat 31phosphorous magnetic resonance spectroscopy (31P-MRS) imaging to determine how treatment with CNM-Au8 results in changes of CNS metabolic and membrane biomarkers. Participants drink a 2 oz. dose of the nanocrystal suspension daily each morning for 12 weeks. Results of the study are expected in the second half of 2020.
Clene Nanomedicine, Inc. is a privately-held, clinical-stage biopharmaceutical company, focused on the development of unique therapeutics for neurodegenerative diseases. Clene has innovated a novel nanotechnology drug platform for the development of a new class of orally-administered neurotherapeutic drugs. Founded in 2013, the company is based in Salt Lake City, Utah with R&D and manufacturing operations located in North East, Maryland. For more information, please visit www.clene.com.
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SOURCE Clene Nanomedicine, Inc.