MediciNova to Present MN-001 Studies at 92nd EAS Congress 2024

MediciNova, Inc., a biopharmaceutical firm listed on the NASDAQ Global Market (MNOV) and the Tokyo Stock Exchange (Code Number: 4875), recently showcased their latest research at the 92nd European Atherosclerosis Society (EAS) 2024 Congress, held online from May 26-29, 2024. The company presented two significant posters detailing their ongoing studies on the therapeutic potential of MN-001 (Tipelukast) and its metabolite MN-002.

Dr. Kazuko Matsuda, MediciNova's Chief Medical Officer, shared updates on a Phase 2 clinical trial evaluating MN-001's efficacy, safety, and tolerability in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). As of April 25, 2024, the trial had enrolled 33 patients, with 19 randomized and 14 having completed the study. Three serious adverse events were reported, but were deemed unlikely or unrelated to the drug. The presentation covered the clinical background, study objectives, design, inclusion criteria, and status of the trial in the U.S.

Dr. Huicheng Qi presented findings on MN-002's role in promoting macrophage cholesterol efflux, a collaborative research effort with Professors Masatsune Ogura and Takashi Miida from Juntendo University. The study aimed to assess the effects of MN-001 and MN-002 on cholesterol efflux capacity in THP-1 macrophages, focusing on key proteins ABCA1 and ABCG1. Cholesterol efflux was measured using RT-PCR for mRNA expression and Western blotting for protein levels.

Results highlighted that MN-002 significantly enhances both ApoA1 and HDL-mediated cholesterol efflux. Specifically, MN-002 increased ApoA1-mediated cholesterol efflux by 44.3% and HDL-mediated efflux by 15.3% compared to the control group. Additionally, MN-002 was shown to boost ABCA1 and ABCG1 protein levels dose-dependently. At a concentration of 10 µM, ABCA1 protein expression increased approximately two-fold while ABCG1 protein levels rose 2.8-fold. The study also revealed that MN-002 enhances ABCA1, ABCG1, and LXR-alpha mRNA expression in a time- and dose-dependent manner. Notably, the increase in ABCA1 protein levels by MN-002 was found to be independent of the Protein Kinase A (PKA) signaling pathway.

NAFLD, a liver manifestation of metabolic syndrome, is linked to a higher incidence of cardiovascular disease, Type 2 Diabetes Mellitus (T2DM), chronic kidney disease, and certain cancers. Up to 80% of NAFLD cases present with dyslipidemia, underscoring the importance of effective treatments.

MN-001 (Tipelukast) is an orally bioavailable compound with potential anti-inflammatory and anti-fibrotic effects. It acts through various mechanisms, including leukotriene receptor antagonism, inhibition of phosphodiesterases, and the 5-lipoxygenase pathway. Preclinical models have shown MN-001 to down-regulate fibrotic and inflammatory gene expressions and inhibit triglyceride synthesis in hepatocytes.

MediciNova, Inc. is focused on developing small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Their pipeline includes MN-166 (ibudilast) and MN-001 (Tipelukast), with multiple mechanisms of action and strong safety profiles. MN-166 is in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and Phase 3-ready for progressive multiple sclerosis (MS). It's also being tested in Phase 2 trials for Long COVID and substance dependence. MN-001 is under Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and NAFLD. The company has a history of securing grants for investigator-sponsored clinical trials.

In summary, MediciNova's presentations at the EAS 2024 Congress underscored the promising potential of MN-001 and MN-002 in treating NAFLD and promoting cholesterol efflux, marking significant steps in their ongoing research and development efforts.