Biopharmaceutical company MediciNova Inc. announced that preliminary results from a hospital emergency department (ED)-based Phase 2b clinical trial evaluating MN-221 in patients with acute exacerbations of asthma did not statistically meet the primary endpoint, improvement in FEV1 (Forced Expiratory Volume in One Second) compared to placebo. However, MN-221 showed a significant benefit over placebo for FEV1 (liters) Area Under the Curve (AUC Hour 0-1, 0-2, 0-3) of change from baseline (p=0.043, p=0.050, p=0.066 respectively) in the data set defined below. The trial also demonstrated a reduction in hospital admissions with MN-221 added to standard drug treatments. Moreover, there was a significant improvement in clinical symptoms with MN-221 treated patients and the safety profile of MN-221 continues to be positive as no safety/tolerability issues of clinical significance were observed.
“Although we did not realize statistical significance in our pre-defined primary endpoint, MN-221 displayed the positive efficacy and safety data we expected to see,” said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova. “We believe certain variables, such as administration of off-protocol therapies, especially in the standard-of-care alone group (placebo arm) and somewhat higher-than-anticipated variability in measuring FEV1 values limited the MN 221 outcomes. Our goal is to control for these variables going forward, enabling us to run a successful Phase 3 program. Accordingly, we have filed our End-of-Phase 2 meeting request with the Division of Pulmonary, Allergy, and Rheumatology Products at FDA.”
MediciNova intends to design pivotal trial(s) that will include technological and operational improvements and further controls for medications that are not typically used in the treatment of acute exacerbations of asthma and were over-represented in the standard-of-care only group in this study.
“Acute asthma exacerbations, which are asthma attacks not controlled by a patient’s medications, represent a major cause of ED visits and hospitalizations for many of the 26 million people with asthma in this country,” said lead investigator Dr. Lawrence Lewis, M.D., of Washington University and Barnes-Jewish Hospital in St. Louis, MO.
“If the asthma attack can’t be effectively treated in the ED, these patients are usually admitted to the hospital for further treatment, a costly alternative for patients and a significant drain on healthcare resources. Unfortunately, we are limited to only a few medications that have been shown to help in the emergency treatment of asthma exacerbation, and often
the patient has already tried most of these medications at home. There is clearly an unmet need for more effective treatments for the emergency care of this condition. We are very pleased that MediciNova will continue development of MN-221 to address this unmet medical need.”
The data set presented below includes more than 85% of the 164 efficacy evaluable patients in the trial. This includes patients from all of the sites that enrolled a minimally sufficient number of patients (greater than three) and for whom all efficacy data were available including FEV1, dyspnea, respiratory rate, and hospitalization.
Highlights of MN-221-CL-007 Trial:
• Overall FEV1 improvement was better in the MN-221 treatment group than the placebo and standard-of-care (SOC) alone group.
• MN-221 showed a significant benefit over SOC alone for FEV1(L) Area Under the Curve (AUC Hr 0-1, 0-2, 0-3) of change from baseline, (p=0.043, p=0.050, p=0.066 respectively)
• MN-221 showed a significant improvement in clinical respiratory parameters including dyspnea score (shortness of breath).
• MN-221 improved AUC (Hr 0-3) of change in dyspnea score by 34% more than SOC alone (p=0.055)
• Fewer patients were hospitalized in the MN-221 treatment group than standardof-care (SOC) alone group.
• MN-221 reduced the overall hospitalization rate by 17% vs. SOC alone
• There were no significant clinical safety concerns when adding MN-221 to standard treatments.
Positive improvements support further development of MN-221 as detailed in the attached release and tables.
“We are very encouraged to see confirmation of improved respiratory and clinical outcomes of MN-221 above the standard therapies, consistent with current practice guidelines,” said Dr. Kazuko Matsuda, Chief Medical Officer, MediciNova. “In addition, there were no discontinuations due to treatment-emergent adverse events in the patient population.”
With regards to safety/tolerability findings, other than asthma-related events, there were only three serious adverse events in the study including one case of bronchitis in the placebo group, one case of bronchitis in the MN-221 group, and one case of pneumonia in the MN-221 group.
Date: May 23, 2012
Source: MediciNova Inc.
