MediciNova begins program to evaluate MN-221 to treat severe asthma

By E. Janene Geiss

Philadelphia, June 13 - MediciNova, Inc. announced Tuesday the start of a clinical development program designed to evaluate the safety and efficacy of MN-221, a highly selective B2-adrenergic receptor agonist, for the treatment of status asthmaticus.

Status asthmaticus is a long-lasting and severe asthma episode in which asthma symptoms are not responsive to initial bronchodilator or corticosteroid therapy, officials said in a company news release.

Status asthmaticus is an emergency situation that can lead to death, officials said.

MediciNova said it has developed and studied an intravenous formulation of MN-221 appropriate for hospital use.

The company said it plans to begin a phase 2 study in patients with status asthmaticus under a Investigational New Drug application for this indication later this year, representing MediciNova's eighth development program, seven of which will be in phase 2 or phase 3 this year.

"MN-221 offers the potential clinically important advantages of fewer cardiovascular side effects than older B-adrenergic agonists due to its greater selectivity for the B2-adrenergic receptor with the convenience and immediacy of intravenous delivery," Yuichi Iwaki, executive chairman and chief executive officer, said in the release.

Despite significant improvements in the treatment for asthma over the past 20 years, there has not been a corresponding decrease in either hospitalizations or deaths due to asthma.

MN-221 is a novel, highly selective B2-adrenergic receptor agonist licensed from Kissei Pharmaceutical Co., Ltd. for development by MediciNova for the treatment of preterm labor, and now also, status asthmaticus.

Preclinical studies conducted in vitro and in vivo show MN-221 to be highly selective for the B2-adrenergic receptor, officials said.

In January 2005, MediciNova started a clinical study in the United States to develop MN-221 for the management of preterm labor based on preclinical and clinical data involving more than 280 healthy volunteers and patients in preterm labor.

MediciNova said it has completed an additional phase 1 study using a relatively rapid intravenous infusion of MN-221, followed by a slower rate of infusion suitable for emergency use in treatment of preterm labor or status asthmaticus.

MediciNova is a San Diego specialty pharmaceutical company.

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