Positive top-line results from phase II clinical trial of MN 166 in hospitalized COVID-19 patients at risk for acute respiratory distress syndrome.

MN 166 (ibudilast) demonstrated large improvements compared to placebo for all four clinical endpoints analyzed. The trial achieved statistical significance for one of the co-primary endpoints, the proportion of subjects free of respiratory failure. The trial also achieved statistical significance for the proportion of subjects discharged from the hospital. The clinical trial enrolled 36 subjects and randomized 34 subjects including 17 subjects in the MN 166 (ibudilast) group and 17 subjects in the placebo group. Male and female participants (mean age = 60 years) were equally represented in MN 166 (ibudilast) and placebo treatment groups. The top-line results include analysis of two pre-defined co-primary endpoints and two additional endpoints.

Co-primary endpoint of the proportion of subjects free from respiratory failure at Day 7 : i. 71% of subjects in the MN-166 (ibudilast) group and 35% of subjects in the placebo group were free of respiratory failure at Day 7 (p=0.02). ii. Co-primary endpoint of clinical status (i.e., improvement on NIAID scale) at Day 7: 71% of subjects in the MN 166 (ibudilast) group and 47% of subjects in the placebo group had improved clinical status at Day 7 (p=0.08). iii. Proportion of subjects discharged from the hospital at Day 7: 65% of subjects in the MN 166 (ibudilast) group and 29% of subjects in the placebo group were discharged from the hospital at Day 7 (p=0.02). iv. Proportion of subjects with worsening of clinical status at Day 7: 0% of subjects in the MN 166 (ibudilast) group and 24% of subjects in the placebo group had worsened clinical status at Day 7 (p=0.05). v. There were two deaths in the placebo group and no deaths in the MN-166 (ibudilast) group. vi. There were no serious adverse events related to MN 166 (ibudilast).

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We wish to express our sincere thanks to the investigators, their staff, and the study participants for their dedication and courage to conduct and volunteer for this trial. The vaccines had not rolled out when this study commenced and health professionals placed themselves at risk while treating severely ill patients with COVID-19 infections who were willing to participate in this study despite the uncertainty of their outcomes. We are pleased to report the positive top-line results from this study. We believe MN 166 has potential for efficacy in all patients with risk for ARDS and acute lung injury caused by COVID-19 or other infections or causes. There is a large unmet medical need for better treatments as the current rate of death in the hospital is approximately 40% for ARDS patients. We plan to discuss the results of this study with the FDA and get their feedback to determine next steps."

About the Clinical Trial : This study was a multi-center, randomized (1:1), double-blind, placebo-controlled, parallel-group study of MN 166 (ibudilast) in hospitalized patients with COVID-19 at risk for developing ARDS and receiving standard of care, including anticoagulation therapy. Major inclusion criteria for trial eligibility included confirmed SARS-CoV-2 infection, oxygen saturation (SpO2) less than 92% on room air, chest imaging with abnormalities consistent with COVID-19 pneumonia and had at least one risk factor that posed a higher risk for more severe illness from COVID-19. Eligible participants were randomly assigned to MN 166 (ibudilast) 100 mg/day or matching placebo treatment for 7 days. The co-primary objectives include the proportion of subjects free from respiratory failure and subjects’ change in clinical status measured by the NIAID scale at Day 7. Assessments performed include clinical status, oxygen therapy use status, adverse events, and survival status.