MediciNova, Inc., a biopharmaceutical company, focuses on acquiring and developing novel and small molecule therapeutics for the treatment of serious diseases with unmet medical needs for the United States market. Its product candidates include MN-166 (Ibudilast), an anti-inflammatory and neuroprotective agent, which has completed Phase II clinical trials for the treatment of neurological disorders; MN-221 (Bedoradrine), a ß2-adrenergic receptor agonist that has completed Phase IIb clinical trails for the treatment of acute exacerbations of asthma; MN-001 (Tipelukast), an orally bioavailable small molecule compound, which has completed a pre-clinical study for the treatment of nonalcoholic s...
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Founded in 2000
MediciNova, Inc. Announces FDA Approval on Clinical Protocol to Evaluate the Effects of MN-166 (Ibudilast) in ALS Patients
Nov 9 15
MediciNova Inc. announced that the FDA (U.S. Food and Drug Administration) has approved the protocol of a new clinical trial in ALS patients, 'A Single-Center, Open-Label Biomarker Study to Evaluate MN-166 (ibudilast) in Subjects with Amyotrophic Lateral Sclerosis (ALS)'. This study is a collaborative effort between MediciNova Inc. and Drs. Nazem Atassi and Haruhiko Banno, Principal Investigators at Massachusetts General Hospital's (MGH) Neurological Clinical Research Institute (NCRI) and Harvard Medical School to measure the effects of MN-166 on reducing brain microglial activation utilizing a biomarker in 15 subjects with ALS. This trial is expected to commence shortly.
MediciNova Plans Phase 2 Trial of Pulmonary Fibrosis Drug
Oct 9 15
MediciNova (MNOV) reported it plans a phase 2 clinical trial of MN-001 (tipelukast) to treat moderate to severe idiopathic pulmonary fibrosis (IPF), or thickening of lung issue. MediciNova said the phase 2 trials, slated for fall, follow an agreement with Penn State on development of the lung drug. MediciNova said the phase 2 trial is a single-center, randomized, placebo-controlled, double-blind six-month study followed by an open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in subjects with moderate to severe IPF. The primary efficacy endpoints of the study are to evaluate the effect of MN-001 on change from baseline of forced vital capacity (FVC) and FVC% predicted up to 26 weeks, and the semiannual rate of decline of disease activity based on forced vital capacity (FVC). Secondary endpoints include safety and tolerability, semiannual rate of decline on disease activity based on the 6-minute walk test (6MWT), change from baseline on disease activity based on Modified Medical Research Council Dyspnea Score (MMRC), change from baseline on quality of life (QOL) measured by A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF), frequency of worsening IPF, and time to first worsening of IPF. MediciNova said the FDA has already approved the protocol for this clinical trial of MN-001 (tipelukast) for the treatment of moderate to severe IPF. Importantly, due to safety data from previous clinical studies of MN-001, FDA agreed that MediciNova may proceed with a Phase 2 study as the first clinical trial of MN-001 in IPF. The IPF protocol was filed under MediciNova's open IND (Investigational New Drug Application) in FDA's Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). MediciNova noted that the FDA granted orphan-drug designation to MN-001 for the treatment of IPF, which will provide MediciNova with seven years of marketing exclusivity if MN-001 is approved for IPF, as previously announced. Additionally, the FDA granted Fast-Track Designation to MN-001 for the treatment of IPF, which expedites the review process and emphasizes frequent communication between the FDA and the sponsor throughout the drug development process. Pulmonary fibrosis (PF) is a progressive disease characterized by scarring of the lungs that thickens the lining, causing an irreversible loss of the tissue's ability to transport oxygen. The causes of PF vary and can be due to anti-cancer drug therapy or exposure to chemicals. Idiopathic pulmonary fibrosis (IPF) is one type of PF without a clear cause. According to the Coalition for Pulmonary Fibrosis, IPF affects approximately 128,000 individuals in the U.S., with about 48,000 new cases diagnosed annually. The prognosis for IPF is poor and about two-thirds of IPF patients die within five years of diagnosis.
FDA Grants Fast Track Designation for Medicinova's MN-001 (Tipelukast) for the Treatment of Idiopathic Pulmonary Fibrosis
Sep 10 15
MediciNova Inc. announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for MN-001 (tipelukast) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). In addition to the granting of Fast Track Designation to MN-001 for treatment of IPF, the FDA granted Orphan Drug Designation to MN-001 for treatment of IPF in October 2014, as previously announced.