• Long term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05)
• Significantly improved clinical outcomes associated with long-term daily oral CNM-Au8^® 30 mg treatment (change from original baseline; p<0.05)
• Long-term CNM-Au8 treatment, encompassing up to three years, was well-tolerated; no significant safety findings were observed
• First Phase 2 clinical MS trial of a non-immunomodulatory drug to meet a clinical outcome of improved function supporting remyelination and reparative effects

SALT LAKE CITY, April 16, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), presented the Phase 2 VISIONARY-MS long term extension (LTE) study results at the 2024 American Academy of Neurology (AAN) Annual Meeting in Denver.

During the Emerging Science Session, Dr. Michael Barnett, MBBS, FRACP, FRCP, PhD, from the University of Sydney, presented data demonstrating improved clinical, functional, and structural outcomes associated with daily oral dosing of CNM-Au8 30 mg for up to three years of treatment.

These new long-term results from the Phase 2 VISIONARY-MS clinical trial demonstrated evidence supporting repair and remyelinating effects of CNM-Au8 treatment in patients originally randomized to CNM-Au8. The long-term results further enhance the trial’s findings from the double-blind period, which demonstrated significant improvements on low contrast letter acuity and on the modified MS Functional Rating Scale, the study’s primary and secondary endpoints, with continued improvement observed in the LTE.

The significant and concordant results across multiple paraclinical exploratory endpoints reinforce the evidence for sustained clinical benefit to study participants across multiple clinical outcome measures, associated with consistent improvements in neuronal function and remyelination.

“Phase 2 CNM-Au8 VISIONARY-MS Trial: Long-Term Extension Results” presentation key highlights:

Clinical improvements in cognition and vision

• Participants originally randomized to CNM-Au8 treatment experienced continued significant improvement in vision as measured by low contrast letter acuity. More than half of participants improved by 10 or more letters on a low-contrast Sloan eye chart, with increases of up to 38 letters (mixed model repeat measures, or MMRM vs. original baseline, p < 0.001).
• Participants originally randomized to placebo who transitioned to CNM-Au8 after the 48-week double blind period into the open label extension also experienced significant improvement in vision as measured by low contrast letter acuity following treatment with 30 mg CNM-Au8 (MMRM vs. original baseline, p < 0.05).
• Study participants treated with CNM-Au8 experienced up to 29 points of significant improvement (max score =110) in cognition and working memory as measured by the Symbol Digit Modality Test (SDMT) (MMRM vs. original baseline, p < 0.001).

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.

Forward-Looking Statements

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