Clene presents clinical results of CNM-Au8 30mg treatment

Clene presented full clinical results for CNM-Au8 from the VISIONARY-MS Trial long-term open label extension in participants with stable relapsing multiple sclerosis totaling nearly three years of follow-up at the ninth annual Americas Committee for Treatment and Research in Multiple Sclerosis 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 and chronic optic neuropathy who received background immunomodulatory disease-modifying therapy. In participants originally randomized to CNM-Au8, continued long-term treatment demonstrated significant improvement of vision as measured by low contrast letter acuity through 35 months from randomization. The least-square mean difference at Week 144 for LCLA change across both eyes versus the original randomization baseline of participants assigned to CNM-Au8 was: +8.70 letters. 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 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. The least-square mean difference at Week 144 for mMSFC change versus the original randomization baseline of participants assigned to CNM-Au8 was 0.65. Sustained improvement by up to 1.4 units was observed in individual participants, which represents a return of function. Significant improvements in cognition and working memory, measured by the symbol digit modalities test, were also observed following long-term CNM-Au8 treatment through 35 months from randomization,. The least-square mean difference at Week 144 for SDMT change versus the original randomization baseline of participants assigned to CNM-Au8 was 8.03 points. SDMT also demonstrated clinically significant sustained improvement by up to 29 points in individual participants. CNM-Au8 was safe and well-tolerated during the LTE.