Clene Reports Significant Improvement in Vision and Cognition With CNM-Au8® Treatment in VISIONARY-MS Trial Long-Term Open Label Extension

• Long-term CNM-Au8 treatment demonstrated improvement of vision as measured by low contrast visual acuity (LCLA), an assessment of visual function in people living with multiple sclerosis (MS), through 35 months from randomization, p<0.0001
• Long-term CNM-Au8 treatment demonstrated improvement of cognition, measured by the Symbol Digit Modality Test (SDMT), through 35 months from randomization, p<0.0001
• Treatment was well-tolerated, without a single serious adverse event attributed to CNM-Au8 and no significant safety findings reported

SALT LAKE CITY, Jan. 08, 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 (ALS) and multiple sclerosis (MS), today reported new CNM-Au8^® results from the 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.

After completion of the double-blind period, study participants were offered to continue on CNM-Au8 30mg for up to an additional 96-weeks in the LTE. Analyses are reported for the modified intent to treat (mITT) population that included all study participants with valid clinical data.

• Progressive Vision Improvement: The least-square mean difference (SE) at Week 144 for low contrast visual acuity (LCLA) change across both eyes versus the original randomization baseline of participants assigned to CNM-Au8 was: +8.70 letters (1.88), 95% CI: 5.0 to 12.4, p<0.0001.
  • The LCLA least-squared mean difference (SE) vs. the end of the double-blind period was: +4.0 letters (1.67), 95% CI: 0.72 to7.30, p=0.017.

Low contrast vision demonstrated sustained improvement by up to 38 letters across both eyes in individual participants, which represents multiple row gains on a greyed-out MS eye chart.

• Progressive Cognitive Improvement: The least-square mean difference (SE) at Week 144 for symbol digit modality test (SDMT) change versus the original randomization baseline of participants assigned to CNM-Au8 was: +8.03 (1.52), 95% CI: 5.01 to 11.0, p<0.0001.
  • The SDMT least-square mean difference (SE) vs. the end of the double-blind period was: +3.11 (1.3), 95% CI: 0.55 to 5.68, p=0.018.

Cognitive improvement, particularly working memory and information processing speed, was improved 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 maintained in the LTE for timed 25-foot walk test (T25FWT) and nine-hole peg test (9HPT).

Placebo participants who transitioned to CNM-Au8 during the LTE showed significant improvements versus original baseline in LCLA and SDMT that were generally consistent with the increases observed in participants originally randomized to CNM-Au8. Full clinical results for the LTE will be presented at the ninth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum taking place February 29 – March 2, 2024 in West Palm Beach, Florida.

VISIONARY-MS, designed to investigate the protection or improvement of neurological function in stable relapsing remitting MS participants with chronic optic neuropathy, was a Phase 2 multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) versus placebo over 48 weeks of double-blind treatment. The primary outcome was LCLA improvement. Global neurological improvement, measured by the modified Multiple Sclerosis Functional Composite (mMSFC) including vision, cognition, upper extremity function, and walking speed assessment was the secondary outcome. Nearly all participants (92%) were treated with highly effective immunomodulatory disease modifying therapies (DMTs) as background standard of care. In the double-blind portion of the trial, 73 participants were randomized, with 55 of 69 eligible (80%) participants continued in the LTE.

“These observed long-term clinical improvements for participants with stable disease, over and above background immunomodulatory disease modifying therapy, are unprecedented,” commented Professor Michael Barnett, one of the trial’s key clinical advisors. “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. 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.”

“Despite tremendous advances in immunotherapies for MS, there is a significant unmet need for treatments to prevent neurodegeneration and create opportunities for clinical improvement,” added Dr. Benjamin Greenberg, M.D., Head of Medicine at Clene. “Years have been spent investigating neuroprotective therapies for multiple sclerosis and other neurodegenerative diseases. 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. Clene is currently reviewing these data with prospective pharmaceutical partners interested in MS.”

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 (formerly Twitter) and LinkedIn.

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