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Reported Late Thursday, MediciNova To Meet With U.S. FDA To Discuss Clinical Development Of A Parenteral Formulation Of MN-166

Benzinga · 01/06/2023 00:36

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 a Phase I clinical trial to evaluate MN-166 (ibudilast) 10 mg intravenous (IV) infusion in healthy volunteers (HV) has been completed. The trial results yielded encouraging findings as MN-166 (ibudilast) was delivered intravenously to HV with a favorable safety profile and was well tolerated. There were no concerning adverse events (AEs), all reported AEs were mild, all study drug-related AEs were mild, and none of the AEs were unexpected.

This IV formulation of MN-166 (ibudilast) is being developed for inflammatory disorders, specifically prevention of acute respiratory distress syndrome (ARDS), sepsis, and cytokine release syndrome. In addition, the newly developed IV formulation will provide another option for health care providers to treat hospitalized patients and patients who are unable to swallow capsules.

Kazuko Matsuda, M.D., Ph.D, M.P.H., Chief Medical Officer, MediciNova, Inc., commented, "We are pleased with the results from this Phase I trial and are excited to evaluate the potential of the MN-166 parenteral formulation in acute and severe clinical settings that require fast bioavailability. A parenteral formulation will expand the clinical utility of MN-166 by enabling the treatment of indications for which the oral formulation is not suitable. We will seek guidance from the U.S. Food and Drug Administration to develop a plan to that may ultimately lead to FDA approval for MN-166."

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 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).