On Apr. 8, 2020, MediciNova announced that it had initiated a clinical trial of MN-166 (ibudilast) for acute respiratory distress syndrome (ARDS) caused by COVID-19 (Coronavirus Disease 2019).

The study was conducted by Yale’s Advanced Therapies Group, which is co-directed by Richard Bucala, M.D., Ph.D., Chief, Rheumatology, Allergy & Immunology at Yale School of Medicine and Rheumatologist-in-Chief at Yale New Haven Health.  Dr. Bucala, is credited with the cloning of MIF (macrophage migration inhibitory factor) and its receptor and led prior efforts targeting MIF in autoimmunity and in cancer.

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 of the lungs, and loss of the surfactant, a substance necessary for keeping 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, shallow, and/or rapid breathing. Infections are the most common cause of ARDS. These infections may include the flu, coronavirus, other viruses, and sepsis. The rate of death in the hospital is approximately 40% for ARDS patients.

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Our earlier human studies demonstrated significant reductions of serum MIF level after treatment with MN-166 (ibudilast). It also attenuates activated glial cells, which play a major role in certain neurological conditions. MN-166 (ibudilast)’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, which provide the rationale for treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS) and other neurological diseases such as glioblastoma (GBM), and substance abuse/addiction