Clene Inc. (NASDAQ: CLNN) Presents Findings on Phase 2 VISIONARY-MS LTE at American Academy of Neurology Annual Meeting

• Long-term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 exhibited significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p < 0.05)
• Significantly enhanced clinical outcomes were associated with long-term daily oral CNM-Au8(R) 30 mg treatment (change from original baseline; p < 0.05)
• Long-term administration of CNM-Au8, spanning up to three years, was well-tolerated, with no significant safety concerns identified
• This marks the first Phase 2 clinical trial in MS utilizing a non-immunomodulatory drug to achieve a clinical outcome demonstrating improved function supporting remyelination and reparative effects

Clene (NASDAQ: CLNN), along with its subsidies, “Clene”, and its wholly owned subsidiary Clene Nanomedicine, Inc., a pioneering clinical-stage biopharmaceutical firm dedicated to enhancing mitochondrial health and safeguarding neuronal function to combat neurodegenerative disorders such as amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), unveiled the comprehensive findings of the Phase 2 VISIONARY-MS long term extension (“LTE”) study at the esteemed 2024 American Academy of Neurology (“AAN”) Annual Meeting in Denver (https://ibn.fm/Ro9gg).

During the Emerging Science Session, Dr. Michael Barnett, MBBS, FRACP, FRCP, PhD, representing the University of Sydney, presented compelling data showcasing the sustained clinical, functional, and structural enhancements correlated with the daily oral administration of CNM-Au8(R) 30 mg for a remarkable period of up to three years.

These groundbreaking long-term outcomes from the Phase 2 VISIONARY-MS clinical trial underscored the compelling evidence endorsing the reparative and remyelinating effects of CNM-Au8 treatment. The extended findings build upon the trial’s earlier outcomes from the double-blind phase, which exhibited noteworthy improvements in low contrast letter acuity and the modified MS Functional Rating Scale, serving as the primary and secondary endpoints of the study, with continued enhancements noted during the LTE.

The significant and consistent results observed across a spectrum of paraclinical exploratory endpoints further reinforce the sustained clinical advantages experienced by study participants across various clinical outcome measures, aligning with the consistent enhancements in neuronal function and remyelination.

Key highlights from the “Phase 2 CNM-Au8 VISIONARY-MS Trial: Long-Term Extension Results” presentation include:

1. Enhanced Cognition and Vision

• Individuals originally assigned to CNM-Au8 treatment demonstrated continued substantial enhancement in vision, evidenced by significant improvements in low contrast letter acuity. More than half of the participants exhibited improvements of 10 or more letters on a low-contrast Sloan eye chart, with some achieving increases of up to 38 letters (vs. original baseline, p < 0.001 via mixed model repeat measures analysis, or MMRM).
• Participants initially assigned to placebo, subsequently transitioning to CNM-Au8 following the 48-week double-blind period, also experienced noteworthy improvement in vision, as demonstrated by low contrast letter acuity after receiving treatment with CNM-Au8 30 mg (vs. original baseline, p < 0.05 via MMRM).
• Subjects treated with CNM-Au8 demonstrated significant enhancements of up to 29 points (max score =110) in cognition and working memory as measured by the Symbol Digit Modality Test (“SDMT”) (vs. original baseline, p < 0.001 via MMRM).

2. Physiologic Evidence of Repair and Remyelination

• Participants receiving CNM-Au8 treatment showcased substantial improvements in both amplitude (vs. original baseline, p < 0.01 via MMRM) and latency (vs. original baseline, p = 0.06 via MMRM) as measured by multi-focal visual evoked potentials, serving as physiological indicators of signal strength and speed along the visual pathway, indicative of neuronal health and remyelination, respectively.

3. Structural Evidence of Repair and Remyelination:

• MRI evaluations of axial diffusivity exhibited significant enhancements in T2 brain lesions among study participants treated with CNM-Au8 (vs. original baseline, p < 0.05 via MMRM).
• MRI assessments of T2 lesion myelin water fraction (“MWF”) and magnetization transfer ratio (“MTR”), both indicative of remyelination, demonstrated improvements following long-term CNM-Au8 treatment (MWF: vs. original baseline, p < 0.05 via MMRM; MTR: vs. original baseline, p = 0.06 via MMRM).

CNM-Au8 exhibited excellent tolerability, with no significant safety concerns identified.

“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,” said Dr. Benjamin Greenberg, Head of Medicine for Clene. “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 on the company’s website at https://ibn.fm/06tSN.

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

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