Safety
ideation, sinusitis, paresthesia, nasopharyngitis, TEAEs, deaths, REPAIR-MS
SINUSITIS, ADVERSE EVENTS, DISEASE, NASOPHARYNGITIS, PARESTHESIA, ADVERSE EVENT
A total of 8 (61.5%) REPAIR-MS participants and 6 (46%) REPAIR-PD participants experienced at least one treatment emergent adverse event (TEAE). All TEAEs were reported as mild or moderate; no participants experienced TEAEs reported as severe. No participants experienced TEAEs that were considered related to study drug by the study investigators. There were no serious adverse events (SAEs), no TEAEs resulting in study discontinuation, and no deaths. TEAEs occurring in more than one participant across both disease cohorts included sinusitis (n = 3), nasopharyngitis (n = 3), and paresthesia (n = 2). Other safety parameters that were assessed included hematology, serum chemistry, urinalysis, physical exam, electrocardiogram, and the CSSRS. CSSRS data revealed no suicidal ideation from any participants across both studies. Of the laboratory assessments, only one clinically significant finding (elevated creatine kinase) was reported in the REPAIR-MS cohort for a participant at the baseline visit. The safety lab was collected prior to participant dosing with CNM-Au8 and was found to resolve within two weeks at this participant’s next visit, while treated with CNM-Au8. The participant’s creatine kinase remained within the normal range throughout the remainder of the study. In conclusion, CNM-Au8 was well-tolerated, and no safety signals were observed in either cohort.