MediciNova Announces Positive Top-Line Results from Phase 2 Clinical Trial of MN-166 (ibudilast) in Hospitalized COVID-19 Patients at Risk for Acute Respiratory Distress Syndrome
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: 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).
- 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).
- 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).
- 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).
- There were two deaths in the placebo group and no deaths in the MN-166 (ibudilast) group.
- There were no serious adverse events related to MN-166 (ibudilast).
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) ≤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.
About Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) is a frequently lethal lung condition caused by excessive inflammation for which there are no effective therapies beyond supportive care. Normally, the lung exchanges oxygen for carbon dioxide in small airway sacs called alveoli. In ARDS, there is extensive inflammation and tissue injury in the alveoli, and loss of the surfactant, a substance necessary for keeping the alveoli open. These changes prevent the lungs from filling properly with air and providing the body with enough oxygen, causing life-threatening difficulty breathing. ARDS may develop over a few days, or it can get worse very quickly. The first symptom of ARDS is usually shortness of breath. Other signs and symptoms of ARDS are low blood oxygen, and shallow and/or rapid breathing. Infections, including the flu, coronavirus, and other viruses, are the most common cause of ARDS. According to the
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund
Source: MediciNova, Inc.
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