MediciNova, Inc. 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 (COPD).
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 GlaxoSmithKline’s (GSK - Free Report) Advair.
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.