MediciNova announced it plans to initiate development of MN-166 (ibudilast) for severe pneumonia and acute respiratory distress syndrome (ARDS). MediciNova’s decision to pursue development of this indication was based on positive results of a recent preclinical study in an animal model of ARDS. Results of this preclinical study showed that ibudilast treatment reversed histological changes observed in the ARDS mouse model including inflammation, hemor¬rhage, alveolar congestion, and alveolar wall edema. In this study, the pulmonary edema score was used to assess the degree of lung water accumulation. Importantly, pulmo¬nary edema was significantly reduced by ibudilast treatment (p<0.001). Results of this study also showed that ibudilast significantly reduced the levels of inflammatory cytokines including TNF-alpha (p<0.001), IL-1beta (p<0.001), IL-6 (p<0.001), and MCP-1 (p<0.001) in a dose-dependent manner, indicating that ibudilast suppressed the inflammatory response. Results of this study also suggest that ibudilast protects against pulmonary injury by attenuating cell apoptosis in lung tissue.

"We are very pleased to announce our initiation of development of MN-166 for severe pneumonia and ARDS. Severe pneumonia and ARDS are very serious conditions which are often caused by viral infections and often are fatal in hospitalized patients. Considering the global outbreak of influenza and coronavirus, it’s very important to develop an efficient and safe treatment for these conditions. We believe that MN-166 has great potential for the treatment for severe pneumonia and ARDS patients based on its anti-inflammatory mechanism and strong results from the ARDS animal model study," Yuichi Iwaki, M.D. Ph.D., President and Chief Executive Officer of MediciNova, said.

Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes low blood oxygen. In ARDS, fluid builds up inside the tiny air sacs of the lungs, and surfactant breaks down. Surfactant is a foamy substance that keeps the lungs fully expanded so that a person can breathe. These changes prevent the lungs from filling properly with air and moving enough oxygen into the bloodstream and throughout the body. The lung tissue may scar and become stiff. 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, rapid breathing, and clicking, bubbling, or rattling sounds in the lungs when breathing. Infections are the most common risk factors for ARDS. These infections may include the flu, coronavirus or 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. MediciNova is developing MN-166 for ALS, progressive MS and other neurological conditions such as degenerative cervical myelopathy (DCM), glioblastoma, substance abuse/addiction, and chemotherapy-induced peripheral neuropathy. MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including ALS, progressive MS, and drug addiction.

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