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Biopharma Co. Meets Primary Endpoints in ARDS Trial
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MediciNova Inc. shares traded 9% higher after the company released top-line data from its Phase 2 study of MN-166 (ibudilast) in hospitalized COVID-19 patients deemed to be at elevated risk for acute respiratory distress syndrome. In the study, MN-166 demonstrated significant decreases in respiratory failure.

Clinical-stage biopharmaceutical company MediciNova Inc. (MNOV:NASDAQ), which is engaged in the development of several novel small molecule therapies for use in treatment of fibrotic, inflammatory and neurodegenerative diseases, today announced "positive top-line results from MediciNova's Phase 2 clinical trial of MN-166 (ibudilast) in hospitalized COVID-19 patients at risk for developing acute respiratory distress syndrome (ARDS)."

MediciNova advised that over the course of the study MN-166 (ibudilast) was shown to provide large improvements in each of the four predetermined clinical endpoints versus the control group. The company highlighted that MN-166 (ibudilast) had significantly achieved one of the trial's co-primary endpoints which was identified as the percentage of patients who remained free of respiratory failure. The firm stated that it also successfully achieved another key objective endpoint in the study based upon the proportion of subjects who were discharged from the hospital.

The company advised that the multi-center, randomized, double-blind study enrolled a total of 36 hospitalized male and female patient subjects with an average (mean) age of 60. Each of the hospitalized patients were confirmed to be infected with SARS-CoV-2 and were identified as at risk for developing ARDS and were receiving standard of care, including anticoagulation therapy.

Of the 36 participants, half (17) were treated with MN-166 (ibudilast) 100 mg/day for a period of 7 days and the other half (17) were administered a daily placebo. The groups included equal numbers of men and women.

The firm noted that the top-line results announced pertain to analysis of results related to two pre-established endpoints and two other secondary endpoints. MediciNova reported that after seven days of treatment with MN-166 (ibudilast), 71% of subjects in the treated group remained free from respiratory failure, compared to 35% of subjects in the control group.

The firm added that 71% of subjects in the group that had been treated with MN-166 (ibudilast) also successfully met the study's co-primary endpoint of clinical status which was measured based upon improvement on the NIAID scale at Day 7, which once again was a higher improvement than that recorded in the placebo group of 47%.

The company provided the data for two other key secondary endpoints and mentioned that 65% of subjects in the MN-166 (ibudilast) group were able to be discharged from the hospital after seven days versus 29% of subjects in the control group.

The firm indicated that that the clinical status (condition), 7% of subjects in the MN-166 (ibudilast) group and 24% of subjects in the placebo group had deteriorated at Day 7 with no deaths in the MN-166 (ibudilast) group but two registered deaths in the placebo group.

The company's Chief Medical Officer Kazuko Matsuda, M.D., Ph.D., M.P.H. stated, "We are pleased to report the positive top-line results from this study. We believe MN-166 has potential for efficacy in all patients with risk for ARDS and acute lung injury caused by COVID-19 or other infections or causes. There is a large unmet medical need for better treatments as the current rate of death in the hospital is approximately 40% for ARDS patients. We plan to discuss the results of this study with the FDA and get their feedback to determine next steps."

The firm mentioned that "ARDS is a frequently lethal lung condition caused by excessive inflammation for which there are no effective therapies beyond supportive care."

The company explained that "MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF)." The firm advised that in addition to the above ARDS study, MN-166 (ibudilast) is currently being evaluated in other late-stage clinical trials as a potential treatment for neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), degenerative cervical myelopathy (DCM) and several other indications.

MediciNova is biopharma firm headquartered in La Jolla, Calif. The company focuses on discovering and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs in several key areas including neurology, respiratory and liver diseases. The company noted that at present it has 11 active programs in various stages of clinical development. The firm indicated that the two leading compounds in its development pipeline are MN-166 (ibudilast) for neurological disorders and MN-001 (tipelukast) for fibrotic diseases. The company is also developing another compound called MN-221 for treating respiratory diseases such as asthma and COPD.

MediciNova began the day Wednesday with a market cap of around $115.3 million with approximately 49.0 million shares outstanding and a short interest of about 2.5%. MNOV shares opened almost 15% higher Wednesday at $2.70 (+$0.35, +14.89%) over Tuesday's $2.35 closing price. The stock traded Wednesday between $2.51 and $2.7699 per share and closed for trading at $2.56 (+$0.21, +8.94%).

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