LA JOLLA, Calif. – 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 it has received a Notice of Intention to Grant from the European Patent Office for a pending patent application which covers the combination of MN-166 (ibudilast) and riluzole for the treatment of amyotrophic lateral sclerosis (ALS).
Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than November 2035. The allowed claims cover the combination of MN-166 (ibudilast) and riluzole for use in a method of treating a patient with ALS wherein the treatment results in stabilization of the patient’s scleroses state. The allowed claims cover a wide range of doses and dosing regimens for both MN-166 (ibudilast) and riluzole.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased to receive notice that this new patent will be granted. Previously, similar patents were granted in the U.S. and Japan based on data from our first clinical trial in ALS patents. We previously announced results of a “responder analysis” which found that the proportion of responders, defined as stable or improved in ALS functional score, muscle test and subjective ALSAQ-5 quality of life assessment, was higher in the MN-166 plus riluzole-treated group compared to the riluzole-only group. We believe this new patent could substantially increase the potential value of MN-166. We are currently conducting a Phase 3 clinical trial with ALS patients in the U.S. and Canada using MN-166 plus riluzole. The U.S. FDA granted both orphan-drug designation and fast-track designation to MN-166 for the treatment of ALS, and the European Commission granted Orphan Medicinal Product Designation to MN-166 for the treatment of ALS.”
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak. As a result, ALS affects voluntary movement and patients in the later stages of the disease may become completely paralyzed. Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 16,000 ALS patients in the U.S. and approximately 5,000 people in the U.S. are diagnosed with ALS each year.
About MN-166 (ibudilast)
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, as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19. 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.
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. market. MediciNova’s current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), degenerative cervical myelopathy (DCM), substance dependence (e.g., alcohol use disorder, methamphetamine dependence, opioid dependence) and glioblastoma (GBM), as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). MediciNova’s pipeline also includes MN-221 (bedoradrine) and MN-029 (denibulin). For more information on MediciNova, Inc., please visit www.medicinova.com.