Clene Presents Clinical Results of CNM-Au8 30mg Treatment From Visionary-MS Trial Long-Term Extension at Annual ACTRIMS Forum 2024

• Long-term CNM-Au8 treatment demonstrated significant and clinically meaningful improvement of vision as measured by low contrast letter 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 were reported
  

SALT LAKE CITY, Feb. 29, 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 presented full clinical results for CNM-Au8 from the VISIONARY-MS Trial long-term open label extension (LTE) in participants with stable relapsing multiple sclerosis (RMS) totaling nearly three years of follow-up at the ninth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in West Palm Beach, Florida.

The data presentation, titled “CNM-Au8 VISIONARY-MS Trial | Long Term Extension Clinical Results,” includes clinical results from the VISIONARY-MS Phase 2 long-term open label extension in participants with stable relapsing multiple sclerosis (RMS) and chronic optic neuropathy who received background immunomodulatory disease-modifying therapy (DMT). After completion of the double-blind period, 55 of 69 (80%) LTE-eligible study participants continued on CNM-Au8 30mg for up to an additional 96 weeks. Analyses are reported for the modified intent to treat (mITT) population including all study participants with valid clinical data.

In participants originally randomized to CNM-Au8, continued long-term treatment demonstrated significant improvement of vision as measured by low contrast letter acuity (LCLA) through 35 months from randomization, p<0.0001.

• The least-square mean difference (SE) at Week 144 for 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.
• Low contrast vision demonstrated sustained improvement by up to 38 letters across both eyes in individual participants, representing clinically meaningful multiple row gains on a greyed-out MS eye chart.

Long-term CNM-Au8 treatment similarly demonstrated significant improvement of global neurological function measured by the modified MS Functional Composite (mMSFC) scale through 35 months from randomization, p=0.018. The mMSFC scale evaluates low contrast vision, cognition, upper extremity function, and walking speed as a combined mean standardized change.