Evidence for Clene’s CNM-Au8 as a Treatment for Repair and Remyelination in Multiple Sclerosis Presented in the Emerging Science Session at the 2024 American Academy of Neurology Annual Meeting - Seite 2

Physiologic functional evidence of repair and remyelination

• Study participants treated with CNM-Au8 experienced significant improvements in both amplitude (MMRM vs. original baseline, p < 0.01) and latency (MMRM vs. original baseline, p = 0.06) as measured by multi-focal visual evoked potentials, physiologic measures of signal strength and speed along the visual pathway, markers of neuronal health and remyelination, respectively.
  

Structural evidence of repair and remyelination

• MRI measures of axial diffusivity showed significant improvements in T2 brain lesions in study participants treated with CNM-Au8 (MMRM vs. original baseline, p < 0.05).
• MRI measures of T2 lesion myelin water fraction (MWF) and magnetization transfer ratio (MTR), markers of remyelination, improved with long-term CNM-Au8 treatment (MWF: MMRM vs. original baseline, p < 0.05; MTR: MMRM vs. original baseline, p = 0.06).

CNM-Au8 was well-tolerated, and no significant safety findings were observed.

“The development of adjunctive therapies that not only prevent neurodegeneration, but also improve neuronal function with measurable clinical benefit, will fill a major unmet need for people living with MS. In the VISIONARY-MS trial, consistent improvements in multiple clinical and paraclinical endpoints over three years of adjunctive treatment with CNM-Au8 provide clear impetus for a definitive Phase 3 study,” stated Dr. Barnett.

Dr. Benjamin Greenberg, Head of Medical for Clene, noted, “Observing such a profound clinical benefit with corresponding improvements in physiologic measures utilizing a mechanism that does not target immune system modulation has never been demonstrated in prior multiple sclerosis trials. This is a very exciting data set that gives hope to the millions of people who are suffering from this disabling disease.”

The presentation is available in the Presentations section of the Clene website.

About Clene

Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8 is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X and LinkedIn.