Clene Inc. (NASDAQ: CLNN) VISIONARY-MS Trial Data May Support CNM-Au8(R) as Long-Sought-After Multiple Sclerosis Treatment

  • Significant improvements in both vision and cognition, sustained over three years, were reported with CNM-Au8 treatment in results from the long-term open-label extension (“LTE”) of the VISIONARY-MS trial in participants with stable relapsing multiple sclerosis
  • Michael Barnett, a key clinical advisor, hailed the results, observed long term and over and above background therapy. as “unprecedented”
  • A drug that may halt MS disease progression or improve function on top of standard-of-care MS therapies would represent a significant milestone in drug development for this disease
  • Clene will present the full clinical results for the LTE at the ninth annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum scheduled for February 29 through March 2, 2024, in West Palm Beach, Florida

Clene (NASDAQ: CLNN) and its wholly-owned subsidiary Clene Nanomedicine Inc., is 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”). The company recently reported new CNM-Au8(R) results from a long-term open-label extension (“LTE”) of the VISIONARY-MS trial in participants with stable relapsing multiple sclerosis (“RMS”) totaling nearly three years of follow-up (https://ibn.fm/bBbjI).

Clene is closely studying CNM-Au8 because a drug that may halt MS disease progression and may even improve function on top of standard-of-care MS therapies would represent a milestone achievement in drug development for this disease.

After completing the double-blind period, study participants were offered continuance of CNM-Au8 30mg for up to an additional 96 weeks in the LTE. Analyses were reported for the modified intent to treat population that included all study participants with valid clinical data. Clene noted that:

  • Low contrast vision acuity (“LCVA”) demonstrated sustained improvement by up to 38 letters across both eyes in individual participants, representing multiple row gains on a greyed-out MS eye chart.
  • Cognitive improvement, particularly working memory and information processing speed as tested using the symbol digit modality test (“SDMT”), showed improvement by up to 35 points in individual participants, where a three-point change in cognitive processing speed has been deemed notable in other MS studies.
  • Improvements demonstrated during the 48-week double-blind period were sustained in the LTE for the timed 25-foot walk and nine-hole peg tests.

CNM-Au8 is used in combination with other agents, has no known drug-drug interactions, and is designed to improve function in MS.

Clinical effects improving both function and survival were seen in an earlier ALS trial, using the same drug.

Professor Michael Barnett, Professor of Neurology, Brain and Mind Centre, University of Sydney, and one of the trial’s key clinical advisors, said, the observed long-term clinical improvements for participants with stable disease, over and above background immunomodulatory disease-modifying therapy, are unprecedented. “The data show clear overall improvements in vision and cognition for participants treated for nearly three years from randomization. Importantly, these results were robust and consistent,” Barnett added. “Positive impacts on disease progression and the potential to at least partially reverse established disability, if confirmed in a larger study, represent a major therapeutic leap for patients with MS.”

Placebo participants who transitioned to CNM-Au8 during the LTE showed significant improvements compared to the original baseline in LCLA and SDMT, generally consistent with the increase observed in participants originally randomized to Clene’s lead asset.

Dr. Benjamin Greenberg, M.D., Head of Medicine at Clene, underscored the idea that despite tremendous advances in immunotherapies for MS, there is a significant unmet need for treatments to prevent neurodegeneration and create opportunities for clinical improvement. “These data continue to build a strong case in favor of pursuing CNM-Au8 in upcoming Phase 3 studies. Clinically significant improvement is rarely seen in MS patients, and this trial provides evidence of CNM-Au8’s potential to improve function in this population,” Greenberg said. “Clene is currently reviewing these data with prospective pharmaceutical partners interested in MS.”

Clene will present the full clinical results for the LTE at the ninth annual Americas Committee for Treatment and Research in Multiple Sclerosis (“ACTRIMS”) Forum scheduled for February 29 through March 2, 2024, in West Palm Beach, Florida.

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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