SALT LAKE CITY, Jan. 9, 2020 /PRNewswire/ -- Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the dosing of the first patient enrolled in the Phase 2 REPAIR-MS study with its lead nanocatalytic therapy, CNM-Au8, for the treatment of Multiple Sclerosis (MS).
"The objective of the open-label, investigator-blinded REPAIR-MS study is to demonstrate improvements in brain bioenergetic metabolism in multiple sclerosis patients treated with CNM-Au8. Participants will undergo 31phosphorous magnetic resonance spectroscopy (31P-MRS) imaging to show how treatment with CNM-Au8 results in bioenergetic improvement of impaired neuronal redox state," said Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer.
"We are excited to advance CNM-Au8 clinically into our second Phase 2 study for MS patients," said Rob Etherington, President and CEO of Clene. "Our preclinical data with CNM-Au8 demonstrated improvements in cellular bioenergetics, specifically within neurons and oligodendrocytes, which led to the initiation of the VISIONARY-MS Phase 2 study and now the REPAIR-MS Phase 2 trial. Currently, there are no therapies approved for remyelination and we believe CNM-Au8 has the strong potential for myelin repair and protection of neurons in patients with MS, which affects more than 2.5 million individuals worldwide and is one of the most common neurological disorders."
REPAIR-MS is Phase 2 single-center open label, sequential group, investigator blinded study examining the brain metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with MS within 15 years of screening. Participants drink about 2 oz. dose (60 mL) of the nanocrystal suspension daily each morning for 12 weeks. The objective of this study is to advance pharmacologic understanding of CNM-Au8 treatment effects on central nervous system biomarkers related to bioenergetics, neuronal metabolism, and oxidative stress, as indicators of target engagement for CNM-Au8 in patients with MS. The study is taking place at University of Texas Southwestern Medical Center and is being led by Benjamin Greenberg, MD, an internationally recognized expert in treating rare autoimmune disorders of the central nervous system.
CNM-Au8 is a concentrated, aqueous suspension of clean-surfaced faceted nanocrystalline gold (Au) that acts catalytically to support important 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 models. Preclinical data presented at scientific congresses demonstrated treatment with CNM-Au8 in neuronal cultures improved survival of dopaminergic neurons, protected neurite networks, decreased intracellular levels of reactive oxygen species, and improved mitochondrial capacity in response to cellular stress, induced by multiple disease-relevant neurotoxins. Oral treatment with CNM-Au8 restored functional behaviors in a rodent model of Parkinson's disease. CNM-Au8 has received regulatory approval to proceed to clinical studies for the treatment of remyelination failure in patients with multiple sclerosis and neuroprotection in patients with amyotrophic lateral sclerosis (ALS) and Parkinson's disease.
About Multiple Sclerosis
Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms vary from person to person and range from numbness and tingling, to walking difficulties, fatigue, dizziness, pain, depression, blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with three times more women than men being diagnosed with the disease. A recent study led by the National MS Society estimates that nearly 1 million people are living with MS in the United States; twice as many than previously thought.
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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