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MediciNova Announces Opening of Investigational New Drug Application for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19
LA JOLLA, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the
About this update from Medicinova, Inc.
[{"type":"text","content":"LA JOLLA, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention of Acute Respiratory Distress Syndrome (ARDS) has been accepted and is now open with the U.S. Food and Drug Administration (FDA). MediciNova was informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) for the prevention of ARDS in patients with COVID-19 may proceed.\n Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased that this important regulatory step is completed, as we are now pursuing clinical development of MN-166 in patients with COVID-19 who are at risk for developing ARDS. We believe that MN-166 has potential to prevent deaths from COVID-19 by reducing hyperinflammation and cytokine storm. As we previously reported, treatment with MN-166 (ibudilast) reversed histological changes observed in the ARDS mouse model including inflammation, hemorrhage, alveolar congestion, and alveolar wall edema. MN-166 also significantly reduced serum inflammatory cytokines, significantly reduced pulmonary edema in lung tissue, and protected against pulmonary injury by reducing cell apoptosis in lung tissue. In addition to strong evidence from the ARDS mouse model, MN-166 has been identified as a hit compound with potential anti-SARS-CoV-2 effect and its long known anti-thrombotic effect may prevent or treat blood clots in COVID-19 patients, who commonly experience pulmonary embolism. Considering COVID-19’s high infection rate, there is an urgent need to develop an effective and safe treatment in patients at risk of developing ARDS.\" About the Trial Based on review and discussion with FDA, the design of the Phase 2 clinical trial includes the following elements: Randomized (1:1), double-blind, placebo-controlled, parallel group study in hospitalized COVID-19 patients at risk for developing ARDS and receiving standard-of-care including anticoagulation therapy.Subjects will be randomly assigned to receive up to 100 mg/day MN-166 or matching placebo for 7 days; Patients will be followed up at Days 14 and 28;The co-primary objective...