MediciNova Announces Results of Studies under BARDA Contract to Develop MN 166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

LA JOLLA, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the results of the nonclinical studies conducted under its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Two different nonclinical models were used to investigate the potential clinical utility of MN-166 (ibudilast) for the treatment of chlorine-induced lung damage.

The primary objective of the first nonclinical efficacy study was to determine the safety and pharmacological activity of MN-166 (ibudilast) following ALI induced by chlorine (Cl₂) gas inhalation. In this study, single-dose and multi-dose treatments were evaluated. The primary endpoint was the pulmonary function measure PaO₂/FiO₂, which is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.

After a Cl₂ gas challenge to induce moderate ALI (mean PaO₂/FiO₂<200), the test subjects were divided into four different treatment groups - two different doses of MN-166 (ibudilast) (low dose and high dose), a positive control (rolipram), and a negative control (test article vehicle) - which were infused intravenously (IV) over 30 minutes.

In the pilot design single-dose treatment regimen, the test subjects were treated only once after the Cl₂ gas challenge was completed. MN-166 (ibudilast) high dose and the positive control were more efficacious than MN-166 (ibudilast) low dose and the negative control until 12 hours after Cl₂ exposure but this did not yield statistically significant results for overall pulmonary function. MN-166 (ibudilast) was well tolerated and no safety concerns were observed in the single-dose study.   A pharmacokinetic (PK) study was conducted to determine the optimal dosing frequency of MN-166 (ibudilast) in the multi-dose study.