Clene Nanomedicine

Clene is using metal nanocatalysts to solve the energy problems that occur in aging cells and leave us vulnerable to disease. Clene’s approach involves two of the building blocks of energy in the cell: the oxidized and the reduced forms of nicotinamide adenine dinucleotide (NAD+ and NADH, respectively).

Clene believes that elevating NAD+ has therapeutic potential. To explore this idea, Clene has developed a metal nanocatalyst called CNM-Au8. CNM stands for Clean-Surfaced Nanocrystal, and “Au” is, of course, the chemical symbol for gold.

CNM-Au8 stimulated and supported energy metabolic pathways in oligodendrocyte membranes, promoting remyelination of axons and recovery of behavioral functions in animal models of multiple sclerosis.

CNM-Au8 is made by an electrocrystallization process using pure gold wire, water, and sodium bicarbonate to create a suspension of clean, faceted nanocrystals. (The nanocrystals stay clean because they resist the accumulation of potentially toxic organic residues.)

CNM-Au8 is being studied in multiple clinical trials, including two trials for the treatment of multiple sclerosis (MS), a trial for the treatment of Parkinson’s, and two trials for the treatment of amyotrophic lateral sclerosis (ALS).

Once inside cells, catalytically active nanotherapeutics drive critical cellular energy-producing reactions in the setting of disease-related stress while decreasing harmful reactive oxygen species, resulting in improved neuronal and oligodendroglial fitness, function, and survival. By transmitting thousands of energy-supportive electrons per second per nanocrystal, CNM-Au8® has been optimized to accelerate neurorepair, improve neuroprotection, and enhance remyelination. By targeting energy metabolism, CNM-Au8 may be able to protect motor neurons and restore function in ALS patients.

Clene expects a readout soon from a double-blind, placebo-controlled, Phase II trial in ALS patients. This trial will show whether the compound meaningfully improves muscle control in patients’ hands and legs. Blinded data from the RESCUE-ALS study that was reported at the European Network to Cure ALS 2021 Annual Meeting showed a functional change in muscles.

CNM-Au8 is being evaluated in a Phase 3 registration trial for the treatment of amyotrophic lateral sclerosis (ALS).