tipelukast (MN-001) / MediciNova - LARVOL DELTA

MediciNova Announces Completion of Patient Enrollment in MN-001-NATG-202 Clinical Trial of MN-001 (Tipelukast) (GlobeNewswire) - "The MN-001-NATG-202 study is a multi-center, randomized, double-blind, placebo-controlled trial to evaluate MN-001(tipelukast). Patients are randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks....Top-line data are expected by the summer of 2026."

Enrollment closed • P2 data • Hypertriglyceridemia • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

MediciNova Compounds Demonstrate Novel Therapeutic Approach for Atherosclerosis in Peer-Reviewed Publication (GlobeNewswire) - "The research demonstrated that MN-002, the major metabolite of Company’s investigational compound MN-001 (tipelukast), significantly enhanced cholesterol efflux in macrophages by upregulating key transport proteins ABCA1 and ABCG. These findings suggest a novel mechanism of action and potential therapeutic strategy for atherosclerosis and other metabolic disorders."

Clinical data • Atherosclerosis • Dyslipidemia

MediciNova Provides Enrollment Update for Ongoing ALS and Hypertriglyceridemia Clinical Trials (GlobeNewswire) - "MediciNova, Inc...and the Standard Market of the Tokyo Stock Exchange...provides an update on the enrollment of two key ongoing clinical trials for the Company’s developmental compounds MN-166 (ibudilast) and MN-001 (tipelukast), each of which is poised to complete randomization...Specifically, the Company is now down to single digit required randomization in its ongoing Phase 2/3 COMBAT-ALS trial. Concurrently, the Company is seeking the final two randomized subjects for its Phase 2 trial in patients with dyslipidemia and fatty liver disease due to type 2 diabetes....We are actively preparing for regulatory discussions with the FDA, with top-line data anticipated by the end of next year."

P2/3 data • Trial status • Amyotrophic Lateral Sclerosis • Dyslipidemia • Hypertriglyceridemia • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

Enhancement of ABCA1 and ABCG1 Expression and Cholesterol Efflux by a Metabolite of Tipelukast: A Potential Therapeutic Strategy for Atherosclerosis. (PubMed, J Atheroscler Thromb) - "MN-002 offers a novel therapeutic approach for atherosclerosis by upregulating ABCA1 and ABCG1 expression and enhancing ApoA-I-mediated cholesterol efflux. Further studies are required to clarify the underlying mechanisms and assess their clinical potential in atherosclerosis and metabolic disorders."

Journal • Atherosclerosis • Cardiovascular • Diabetes • Metabolic Disorders • ABCA1 • ABCG1 • APOB

MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: MediciNova | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Diabetes • Dyslipidemia • Hepatology • Hypertriglyceridemia • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

MediciNova Announces Two Abstracts regarding MN-001 (tipelukast) and MN-002 Accepted for Presentation at the 92nd EAS 2024 Congress, the Annual Meeting of the European Atherosclerosis Society (GlobeNewswire) - "MediciNova, Inc...and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that two abstracts...have been accepted and selected for poster presentation at the 92nd European Atherosclerosis Society (EAS) 2024 Congress to be held May 26-29, 2024....'One presentation is regarding the objectives and design of the ongoing Phase 2 clinical trial enrolling patients with Type 2 diabetes, dyslipidemia, and NAFLD. The other presentation is regarding the mechanism of action of MN-001/MN-002 in lipid metabolism, particularly the effects on cholesterol efflux capacity.'"

Clinical protocol • P2 data • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus

MediciNova Receives a Notice of Intention to Grant for a New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH in Europe (GlobeNewswire) - "MediciNova...announced it has received a Notice of Intention to Grant from the European Patent Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of advanced nonalcoholic steatohepatitis (NASH). Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than May 2035. The allowed claims cover MN-001 (tipelukast) or MN-002 for the treatment of a patient diagnosed with advanced NASH."

Patent • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

MediciNova Receives a New Patent Covering MN-001 for the Treatment of Scleroderma and Systemic Sclerosis in Europe (GlobeNewswire) - "MediciNova...announced it has received a Decision to Grant from the European Patent Office for a new patent which covers MN-001 (tipelukast) for the treatment of scleroderma and/or systemic sclerosis. This patent is expected to expire no earlier than June 2035. The allowed claims cover the use of MN-001 (tipelukast) for inhibiting or treating scleroderma and/or systemic sclerosis. The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms. The allowed claims cover a wide range of doses and a range of different dosing frequencies."

Patent • Immunology • Multiple Sclerosis • Scleroderma

MediciNova Receives a Notice of Allowance for a New Patent Covering MN-001 for the Treatment of Advanced NASH in Canada (GlobeNewswire) - "MediciNova...and the JASDAQ Market of the Tokyo Stock Exchange...announced it has received a Notice of Allowance from the Canadian Intellectual Property Office for a pending patent application which covers MN-001 (tipelukast) for the treatment of advanced nonalcoholic steatohepatitis (NASH). Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than May 2035. The allowed claims cover MN-001 (tipelukast) for the treatment of a patient diagnosed with advanced NASH....The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms."

Patent • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: MediciNova | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Dyslipidemia • Hepatology • Hypertriglyceridemia • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Type 2 Diabetes Mellitus

MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: MediciNova

New P2 trial • Diabetes • Dyslipidemia • Hepatology • Hypertriglyceridemia • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Type 2 Diabetes Mellitus

MediciNova Receives Notice of Allowance for New Patent Covering MN-001 and MN-002 for the Treatment of Fibrosis in Korea (GlobeNewswire) - "MediciNova...today announced that it has received a Notice of Allowance from the Korean Intellectual Property Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of fibrosis which includes a wide range of fibrotic diseases....Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than June 2035. The allowed claims cover a composition for inhibiting or treating fibrosis, excluding pulmonary fibrosis and certain types of hepatic fibrosis, using MN-001 or MN-002."

Patent • Idiopathic Pulmonary Fibrosis

A Single-Center, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of MN-001 (Tipelukast) in Idiopathic Pulmonary Fibrosis (ATS 2022) - P2 | "In a bleomycin-induced pulmonary fibrosis murine model, MN-001 significantly reduced lung fibrosis and hydroxyproline content...Inclusion criteria: physician diagnosed IPF (ATS Guidelines, 2011), all genders, aged 21 to 80 years, GAP Stage II-III; on no anti-fibrotic or on stable dose nintedanib. Patients on pirfenidone were excluded due to the drug-drug interaction potential.Treatment arms: MN-001 750 mg bid for 12 months (MN-001/MN-001) or placebo for 6 months and MN-001 750 mg bid for 6 months (Placebo/MN-001)... MN-001 750 mg bid treatment was safe and well-tolerated when given to participants with moderate to severe IPF. No preliminary efficacy signal was observed in FVC (%pred.), 6MWT, or mMRC; there was a possible signal for reduced IPF exacerbations. Serum LOXL2 may be a future biomarker."

Clinical • Fibrosis • Gastrointestinal Disorder • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: MediciNova | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Mar 2022

Trial completion • Trial completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

"$MNOV MediciNova Receives a Notice of Allowance for a New Patent Covering MN-001 and MN-002 for Hepatic Ballooning in Canada https://t.co/V2kSYQdxsK #patent" (@stock_titan)

[VIRTUAL] IMPROVEMENT OF INTRACELLULAR LIPID METABOLISM BY TIPELKAST IN THE PATHOGENESIS OF NASH/NAFLD (AASLD 2021) - "In the present study, tipelukast inhibited cellular uptake of AA, reduced TG synthesis and accumulation in hepatocytes, possibly via down-regulation of CD36 expression . Further evaluation of tipelukast’s effects on TG metabolism is warranted ."

Dyslipidemia • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Hypertriglyceridemia • Immunology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Oncology • Solid Tumor • CD36 • FASN • PPARA

MediciNova Reports Second Quarter 2021 Financial Results and Business Update (GlobeNewswire) - P2, N=15; NCT02503657; Sponsor: MediciNova; "Although there were no clinically meaningful trends in favor of MN-001 (tipelukast) for the majority of the clinical outcome measures in this small study, there were no worsening IPF events (acute IPF exacerbation or hospitalization due to respiratory symptoms) in the MN-001 (tipelukast) group compared to one worsening IPF event in the placebo group. MN-001 (tipelukast) demonstrated a substantial reduction in LOXL2, a biomarker for IPF, whereas LOXL2 increased in the placebo group. MN-001 (tipelukast) was safe and well tolerated."

Biomarker • P2 data • Idiopathic Pulmonary Fibrosis

MediciNova Announces Presentation of Positive Findings on MN-001 (tipelukast) in Acute Liver Injury Model at The Liver Meeting Digital Experience™ 2020 (GlobeNewswire) - "MediciNova...today announced that Principal Investigator...Craig McClain...presented positive results of the in-vitro and in-vivo studies that evaluated MN-001 (tipelukast, referred to as D46 in the presentation) for its anti-liver fibrotic effect in human hepatic stellate cells (HSCs) and in an acute liver injury model at the Liver Meeting Digital Experience™ 2020 (TLMdX™), the annual meeting of the American Association for the Study of Liver Diseases (AASLD)....The study was a collaborative effort between MediciNova, Inc., and Drs. Craig McClain..."

Clinical

MediciNova Reports First Quarter 2021 Financial Results and Business Update (GlobeNewswire) - "The Company has completed enrollment in its Phase 2 trial of MN-001 in idiopathic pulmonary fibrosis (IPF). The Phase 2 randomized, placebo-controlled, double-blind trial is evaluating the efficacy and safety of MN-001 in patients with IPF over the course of a 26-week treatment period followed by at 26-week open label extension. The co-primary endpoints of the trial are change from baseline of forced vital capacity (FVC) and semiannual rate of decline of disease activity based on FVC."

Enrollment closed • Idiopathic Pulmonary Fibrosis

[VIRTUAL] A Single-Center, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of MN-001 (Tipelukast) in Subjects with Idiopathic Pulmonary Fibrosis (ATS 2021) - P2 | "In a bleomycin-induced pulmonary fibrosis murine model MN-001 significantly reduced lung fibrosis and lung hydroxyproline content...Inclusion criteria: physician diagnosed IPF (ATS Guidelines; 2011), males and females aged 21 to 80 years, GAP Stage II-III; on no anti-fibrotic or on stable dose nintedanib. Exclusion criteria: malignancy, listed for lung transplantation, on pirfenidone (due to anticipated drug interaction)...During the study, three serious adverse events were reported and were judged to be unrelated to study drug. Following database lock, we will analyze the following endpoints: FVC, 6MWT, MMRC, and ATAQ-IPF.CONCLUSIONS We have successfully completed this single-center, placebo-controlled trial, to evaluate its efficacy, safety and tolerability of MN-001 as a therapy for IPF and are continuing analysis of study outcomes."

Clinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Oncology • Respiratory Diseases • Transplantation

MediciNova Enters into US$20 Million Securities Purchase Agreement with a fund managed by 3D Investment Partners (GlobeNewswire) - “MediciNova…announced that it has entered into a Securities Purchase Agreement pursuant to which MediciNova has agreed to issue US$20 million in shares of its common stock to 3D Opportunity Master Fund…To develop an intravenous formulation of MN-166 (ibudilast), which is ideal for amyotrophic lateral sclerosis (ALS) patients who have difficulty with swallowing. To initiate a Phase 2 clinical trial of MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH).”

Financing • New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • Non-alcoholic Fatty Liver Disease

MEDICINOVA : MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. (form 10-Q) (Market Screener) - "We intend to advance development of MN-001 (tipelukast) through a variety of means, which may include investigator-sponsored trials with or without grant funding as well as trials funded by us....We intend to discuss strategic alliances with leading pharmaceutical companies who seek product candidates, such as...MN-001 (tipelukast)...which could further support our clinical development and product commercialization."

Clinical • Licensing / partnership • Idiopathic Pulmonary Fibrosis • Immunology

MediciNova Announces Positive Findings on MN-001 (tipelukast) in Acute Liver Injury Model to be Presented at The Liver Meeting Digital Experience 2020 (GlobeNewswire) - "MediciNova, Inc....today announced positive findings from a study evaluating MN-001 (tipelukast) in an acute liver injury model will be presented at The Liver Meeting Digital Experience™ 2020 (TLMdX™), an event of the American Association for the Study of Liver Diseases (AASLD). The study is the results of a collaborative effort between MediciNova and Dr. Craig McClain and Dr. Leila Gobejishvili at the University of Lousiville School of Medicine....Due to the COVID-19 pandemic, TLMdX™ will be held November 13-16, 2020 in its digital format. The poster session will be open and available during the entirety of TLMdX™ 2020."

Live event • Preclinical • Idiopathic Pulmonary Fibrosis • Immunology

Tipelukast: Expiry of patents related to treatment of NASH, NAFLD, and liver disorders in December 2032 (MediciNova) - Corporate Presentation: Expiry of patent related to treatment of lipid disorders in July 2034; Expiry of patent related to treatment of advanced NASH in September 2034; Expiry of patent related to treatment of fibrosis in June 2035

Patent • Idiopathic Pulmonary Fibrosis

[VIRTUAL] Description of Protocol to Evaluate MN-001'S (tipelukast) Efficacy, Safety and Tolerability in Subjects with Idiopathic Pulmonary Fibrosis (ATS-I 2020) - P2 | "In a bleomycin-induced pulmonary fibrosis mouse model, MN-001 significantly reduced lung fibrosis and lung hydroxyproline content...Inclusion criteria: physician diagnosed IPF (ATS Guidelines, 2011), males and females aged 21 to 80 years, GAP Stage II-III; on no antifibrotic or on stable dose nintedanib. Exclusion criteria: malignancy, listed for lung transplantation, on pirfenidone (due to anticipated drug interaction)...Five serious adverse events (SAEs) have been reported and all were considered 'unrelated' or 'unlikely related' to study drug and did not meet regulatory reporting requirements. Conclusions A single-site placebo controlled clinical trial of MN-001, a novel antifibrotic agent, to evaluate its efficacy, safety and tolerability as a therapy for IPF is now fully enrolled."

Clinical • Asthma • Fibrosis • Hepatology • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Cystitis • Interstitial Lung Disease • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Oncology • Respiratory Diseases • Transplantation