) recently announced positive preliminary results on intravenous
MN-221 (bedoradrine). The randomized, placebo-controlled phase Ib
trial evaluated the efficacy and safety of MN-221 in patients with
stable, moderate-to-severe chronic obstructive pulmonary disease
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As per preliminary data from the phase Ib trial, MN-221
demonstrated moderately improved pulmonary function compared to
placebo. The data indicated an encouraging pharmacokinetic and
efficacy profile. There were no significant safety concerns
associated with the use of the candidate.
Currently approved COPD treatments include
Forest Laboratories, Inc.'s
) Daliresp and
MediciNova is developing MN-221, a highly selective
beta(2)-adrenergic receptor agonist, for the treatment of acute
exacerbations of asthma and COPD. In 2004, MediciNova licensed
exclusive rights to MN-221 from Kissei Pharmaceutical Co., Ltd. in
all territories except Japan.
Earlier, in May 2012, the company had presented preliminary data
from a hospital emergency department (ED)-based phase IIb trial of
MN-221 for the treatment of acute exacerbations of asthma. Although
the randomized, double-blind, placebo-controlled phase IIb trial
did not meet the primary endpoint, it was observed that the use of
MN-221 resulted in a significant improvement in clinical symptoms.
The company has scheduled an end-of-phase II meeting with the US
Food and Drug Administration (FDA) in late October 2012 regarding
the development of MN-221 for the treatment of acute exacerbations
of asthma. The company also plans to discuss the COPD data from the
phase Ib trial in this meeting.
MediciNova has a diversified pipeline, which includes 6
clinical-stage compounds targeting several indications including
respiratory disorders, neurologic conditions and oncology
conditions. However, we see no near-term catalyst for the stock.
Thus, we maintain a Neutral recommendation on MediciNova. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.