Clene Nanomedicine Inc. announced its Australian subsidiary had completed enrollment and dosing of the first participant in the Phase 2 RESCUE-ALS study with its lead nanocatalytic therapy, CNM-Au8, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The RESCUE-ALS study is substantially funded by FightMND. About RESCUE-ALS: RESCUE-ALS is Phase 2 multi-center randomized, double-blind, parallel group, placebo-controlled study examining the efficacy, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in participants who are newly symptomatic ALS (within 24-months of screening or 12-months from diagnosis) and with a clinically probable or possible or definite ALS diagnosis. Enrolled subjects will be randomized 1:1 to receive either active treatment with CNM-Au8 30 mg or placebo in addition to their current standard of care. Participants will receive their randomized oral treatment daily over 36 consecutive weeks during the Treatment Period. The treatment is taken by mouth once daily first thing every morning. The objective of this study is to assess bioenergetic catalysis with CNM-Au8 to slow disease progression in patients with ALS. 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 a 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.