MediciNova (MNOV) Says Results of Phase 2B Trial of MN-221 Didn't Meet Primary Endpoint; to Move Forward with End of Phase Meeting

May 23, 2012 4:08 PM EDT Send to a Friend
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MediciNova, Inc. (Nasdaq: MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today 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.

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.

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