Clene Nanomedicine, Inc. issued the following announcement on Jan. 24.
Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the receipt of formal acceptance from the U.S. Food and Drug Administration (FDA) to proceed with its CNM-Au8 as one of the first three drug regimens in the HEALEY ALS Platform Trial being conducted by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.
The HEALEY ALS Platform Trial is the first ever platform trial for the treatment of amyotrophic lateral sclerosis (ALS). CNM-Au8 was selected in September 2019 into the HEALEY ALS Platform Trial, which includes substantial financial support and provides access to 54 expert ALS clinical trial sites across the United States. Obtaining a 'May Proceed' notice from the FDA indicates there are no major issues with the study and the FDA agrees the clinical trial can move forward to investigate the efficacy of CNM-Au8. Following receipt of the 'May Proceed' notice from the FDA, the trial will next obtain formal approval from an independent institutional ethics review board and can then start enrolling participants.
"We are thrilled Clene's CNM-Au8 has formally been accepted to participate in the HEALEY ALS Platform Trial and that the Sean M. Healey & AMG Center for ALS at Mass General has been given the 'May Proceed' notice from the FDA," said Rob Etherington, President and CEO of Clene. "ALS affects thousands of people every year and we believe Clene's involvement in this trial has the potential to make a substantial impact in the ALS community. We anticipate people with ALS will be able to have access to CNM-Au8 through the HEALEY ALS Platform Trial in 2020."
About CNM-Au8
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 that treatment with CNM-Au8 in neuronal cultures improved survival of 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 improved functional behaviors in rodent models of ALS, multiple sclerosis, and Parkinson's disease versus vehicle (placebo). 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 Amyotrophic Lateral Sclerosis (ALS)
ALS is a universally fatal neurodegenerative disorder that results in loss of motor neurons in the cerebral cortex, brain stem, and spinal cord. ALS, also known as Lou Gehrig's disease, leads to the death of the neurons controlling voluntary muscles resulting in weakness, muscle atrophy, and progressive paralysis. ALS affects more than 15,000 patients in the United States and is the most prevalent adult-onset progressive motor neuron disease.
About Clene
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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