ACTRIMS 2021 | VISIONARY-MS: pure gold nanocrystals for neurorepair and neuroprotection in MS

Robert Glanzman, MD, FAAN, Clene Nanomedicine Inc, Salt Lake City, UT, shares blinded interim results from the ongoing Phase II double-blind placebo-controlled REPAIR-MS trial (NCT03536559) of CNM-Au8, an aqueous suspension of pure gold nanocrystals, in patients with stable relapsing multiple sclerosis (MS). CMN-Au8 is a novel neurocatalytic drug designed to enhance intracellular reactions critical for neuronal damage repair. To assess the efficacy and safety of the treatment, patients were randomized to receive CMN-Au8 at one of two dose levels or placebo alongside their standard disease-modifying therapy, and changes in Multiple Sclerosis Functional Composite (MSFC) scores were assessed. To analyze the results without unblinding the study, patients with the lowest EDSS scores at baseline were used as a comparator group. The results show that, to date, the overall population has achieved significant improvement in overall MSFC scores and key MSFC sub-scales compared to the comparator group. The study is ongoing and unblinded data is expected next year. This interview took place during the ACTRIMS Forum 2021.