Potential for Combination Approaches in Multiple Sclerosis and Role of CNM-Au8: Michael Barnett, PhD, MBBS, FRACP

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"In an ideal world, when we see a patient and make a diagnosis of MS, we put them on a dual therapy. We’ll give them an anti-inflammatory therapy, but also a neuroprotective therapy, and potentially a proremyelinating therapy from day 1 of the disease because that’s when a lot of the damage is done."

Once perceived as an extremely debilitating disease, advances in therapeutics for multiple sclerosis (MS) have substantially lowered the risk of relapses for patients and improved quality of life. There are over 20 disease-modifying treatments (DMTs) for relapsing forms of the disease, forcing conversations to shift from addressing relapses to stopping neurodegeneration and ongoing lesion burden. One agent in development, CNM-Au8 (Clene Nanomedicine), may serve as a potentially beneficial adjuvant option for patients who are on stable DMTs.

CNM-Au8, an oral suspension of catalytically-active gold nanocrystals, supports brain energy metabolism resulting in neuroprotection and remyelination in preclinical models. The therapy showed significant effects vs placebo in the phase 2 VISIONARY-MS study (NCT03536559), a double-blind, multicenter trial of patients with stable relapsing MS. Over a 48-week period, treatment with the agent resulted in a least square mean difference of 3.13 (95% CI, –0.08 to 6.33; P = .056) in best corrected-low contrast letter acuity, the primary end points, vs placebo. In addition, CNM-Au8 showed significant outcomes on mean difference of standardized modified MS Functional Composite (mMSFC) score (0.28; 95% CI, 0.04-0.52; P = .0197) and difference of mMSFC average ranked sum score (13.4; 95% CI, 2.8-23.9; P = .0138).

CNM-Au8 is currently in development and not indicated for any particular disease. in an interview with NeurologyLive^®, Michael Barnett, PhD, MBBS, FRACP, lead investigator of VISIONARY-MS, sat down to discuss how the agent would fit in the treatment landscape if approved. Barnett, a senior academic at the University of Sydney, spoke specifically about patients who need a combination of therapeutics to effectively manage their disease, as well as whether data from the study identified which patients may be best suited for this approach.

REFERENCE
1. Barnett M, Beadnall H, Klistorner A, et al. VISIONARY-MS top-line results: a phase 2, randomized, double-blind, parallel-group, placebo-controlled study to assess the safety and efficacy of CNM-Au8, a catalytically active gold nonocrystal suspension in relapsing multiple sclerosis. Presented at: 2023 AAN Annual Meeting; April 22-27; Boston, MA. Abstract 004273