The first participant has been dosed in the Phase 2 REPAIR-MS clinical trial examining the effects of CNM-Au8, Clene Nanomedicine‘s investigational remyelinating therapy, on brain metabolism in people with multiple sclerosis (MS), the company announced.
In MS, the immune system attacks myelin, the protective sheath that surrounds neurons, helping them send signals more effectively.
Most approved MS therapies can prevent further myelin damage by reducing the activity of the immune system. However, none of these therapies are able to replace the myelin that has already been lost. For this reason, MS research has been focusing on developing a so-called remyelinating therapy.
CNM-Au8 is a solution of gold nanoparticles with a particular crystal structure that can help facilitate certain chemical reactions within cells. It can also promote the activation of oligodendrocytes, the cells responsible for producing myelin.
Preclinical data in animal models of MS suggested that CNM-Au8 is able to induce remyelination, and preliminary clinical studies in healthy volunteers indicated the medication has a good safety profile.
REPAIR-MS (NCT03993171) is an open-label Phase 2 trial sponsored by Clene to assess the safety, pharmacokinetic and pharmacodynamic properties, and metabolic effects of CNM-Au8 in 24 adults with relapsing-remitting MS (RRMS) diagnosed in the past 15 years.
Pharmacokinetics and pharmacodynamics refer to the interactions between the body and a specific compound. These interactions are analyzed to understand how a medication is absorbed, distributed, metabolized, and then eliminated from the body.
Participants enrolled in the study will drink approximately 2 oz. (60 mL) of CNM-Au8 every morning for 12 weeks.
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