MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the Jasdaq Market of the Osaka Securities Exchange, 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 or 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, the company said.
"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, President and Chief Executive Officer of MediciNova.
"Our goal is to control 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," Yuichi said.
MediciNova said it 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.
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