A New Approach to the Treatment of Severe Asthma Episodes Print E-mail
By Yuichi Iwaki, M.D., Ph.D   
Thursday, 19 April 2012 11:52
The need for novel treatments for patients suffering from acute exacerbations of asthma (AEA), a long-lasting and severe form of asthma episode in which symptoms are unresponsive to initial bronchodilator or corticosteroid therapy, is evident when considering some staggering statistics:   AEA episodes account for more than 1.5 million annual emergency room visits in the U.S. alone, and no new options have been introduced in the emergency setting during the past two decades. The lack of treatment options and increasing costs represent an urgent need for innovative approaches.

The current standard of care for AEA comprises inhaled beta agonists, inhaled anticholinergics, and intravenous or oral corticosteroids.  Unfortunately, these treatments are limited by bronchoconstriction, or insufficient airflow due to inflammation and airway constriction, reducing the amount of inhaled drug that can get into the lungs.  In addition, the amount of these treatments a patient can tolerate is limited due to the potential for cardiovascular side effects (e.g., increased heart rate).  Among those patients who visit emergency rooms annually for AEA in the U.S., around 965,000 respond to initial therapy and are discharged; yet the remaining population of approximately 525,000 patients is hospitalized, with tremendous cost consequences. In fact, a 2007 study published in Respiratory Care, the science journal of the American Association of Respiratory Care, noted the average cost of asthma hospitalization in the U.S. increased from $6,648 in 1994 to $12,100 in 2004.      

One promising treatment approach involves the intravenous administration of bedoradrine sulfate, a novel, highly selective beta(2)-adrenergic receptor agonist.  This compound has been shown in preclinical studies to have a high affinity for the beta(2)-adrenergic receptor, which is located mainly in the lungs, gastrointestinal tract, liver, uterus, vascular smooth muscle, and skeletal muscle; and a much lower affinity for the beta(1)-adrenergic receptor, which located mainly in the heart and in the kidneys.  Its use has been demonstrated not only to successfully bypass constricted airways to deliver the drug directly to the lungs, but also, in clinical studies to date, to show no worrisome increase in heart rate when administered.  

MediciNova (NASDAQ:MNOV), a San Diego and Japan-based biopharmaceutical company, is currently testing bedoradrine sulfate (under the proprietary name MN-221) for this purpose.  In late March, the company announced it had completed enrollment of 176 patients in a Phase 2 clinical trial evaluating the safety and efficacy of MN-221 for the treatment of AEA, and the company anticipates releasing clinical results in the second quarter of 2012.
As noted above, novel treatments for asthma and its most severe manifestations are a must.  Bedoradrine sulfateā€™s improved delivery to the lungs and its cardiac safety profile may help fill an unmet need for AEA patients, enabling them to breathe more easily and avoid a costly hospital stay.  

Yuichi Iwaki, M.D., Ph.D. is Founder, President and Chief Executive Officer of MediciNova, Inc., a biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need.  To reach Dr. Iwaki, please contact Mark Johnson at (858) 373-1500 or [email protected]

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