Clene Inc. and its wholly owned subsidiary Clene Nanomedicine Inc. 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-we 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.4, p. 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.