MediciNova (MNOV) expects to release results from two clinical trials in the current second quarter with its lead drug candidate, MN-221, opening the door to a possible pivotal trial.
"We'll have Phase 2b results by the end of May treating patients with acute exacerbations of asthma (AEA) in the emergency room and results by June from a Phase Ib multi-dose trial in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)," Chief Business Officer, Michael Coffee, says in an interview with BioTuesdays.com.
"Our hope is to move into a Phase III program in acute asthma at the end of 2012 or the beginning of 2013," he adds.
AEA is a severe asthma episode that fails to respond to initial bronchodilator or corticosteroid therapy.
Mr. Coffee explains that these attacks result in approximately two million emergency room visits in the U.S. annually, leading to about 500,000 hospitalizations annually and a nearly similar number of hospitalizations in the U.K., Spain, Germany, Italy and France. The average length of stay for asthma hospitalization is 3.3 days, at an average cost of about $6,500 in the U.S.
MN-221 is a highly selective, full beta-2 adrenergic receptor agonist that represents a new approach to treating these asthmatics.
"The potential advantages over current therapy include improved efficacy through an intravenous route of administration versus inhalation; improved safety, because MN-221 is highly selective for the beta-2 receptor versus beta-1 receptors, which can cause cardiovascular stimulation; and reduced health care costs due to fewer hospitalizations," Mr. Coffee contends.
Pharmacoeconomic Benefit: Price of MN-221 vs. % Hospitalizations
The primary efficacy endpoint for the Phase IIb trial is improvement in forced expiratory volume into a spirometer in one second (FEV1), which is the classic measure used in all asthma trials, he says.
To determine the practical applications of MN-221, the trial is also monitoring several secondary endpoints, such as the reduction in hospital admissions and the improvement in clinical signs of asthma, which are other important symptoms that emergency room doctors monitor in addition to FEV1.
COPD is essentially a smoker's disease which is rampant, according to Mr. Coffee. COPD patients are very vulnerable to infection because they have poor lung function. "When they come to the emergency room, it is with acute exacerbations similar to what an asthma patient may experience. The difference though is that in many cases, they require longer hospitalization to deal with the underlying infection."
He explains that there are about 765,000 hospitalizations in the U.S. annually for COPD exacerbations, averaging 7.4 days in length at an average cost of $32,000. The condition causes about 119,000 deaths a year in the U.S.
"Efficacy and safety data from our COPD program will also be very useful in further development of MN-221 for acute asthma," he adds.
MediciNova was formed in 2000 largely as a vehicle to license-in promising early-stage products from medium-sized Japanese pharmaceutical companies for further development, potential commercialization and partnering. "There was a gap in Japan between large pharma companies that had an expertise to globalize products and medium-sized companies that don't have that ability," Mr. Coffee says.
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MediciNova's alliances include Kissei Pharmaceutical, which originally developed MN-221, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma and Meiji Pharmaceutical University.
In addition to MN-221, the company has also prioritized MN-166 (ibudilast), which has been approved for dizziness after stroke and asthma in Japan and South Korea, and has treated more than three million patients. "But it was our scientists who determined that ibudilast had a potential clinical utility in central nervous system disorders," Mr. Coffee points out.
The company has conducted successful early-stage testing to determine safety and tolerability of higher doses of ibudilast that are used currently to treat asthma in three clinical areas: progressive multiple sclerosis, neuropathic pain and drug addiction.
In progressive MS, Mr. Coffee says the company is organizing a Phase IIb trial with MN-166 and "we anticipate announcing in the second half of this year our plans for conducting that trial."
In drug addiction, there are several MN-166 studies being funded by the National Institute of Drug Abuse, including studies on opioid dependence at Columbia University and methamphetamine addiction at UCLA. Separately, there is a medication overuse headache clinical trial supported by the University of Adelaide in Australia.
"Our strategy with ibudilast is collaboration with a partner, as our primary financial support is committed to MN-221 and getting into Phase III in asthma," Mr. Coffee says.
MediciNova also has non-core programs in asthma, interstitial cystitis, generalized anxiety disorder, thrombosis and overactive bladder that are in various stages of development. The company is seeking to monetize these non-core programs through licensing partnerships.
In modeling the market potential of MN-221, Mr. Coffee says that if the company can demonstrate a reduction in hospital admissions, he believes that insurance payers would feel comfortable with an attractive branded price. In an earlier Phase IIa trial, the company generated data showing a 54% reduction in potential hospital admissions.
"Given that, we've extrapolated to show that acute asthma and COPD exacerbations represent a combined annual worldwide sales potential in excess of $1 billion," he adds.
Outside of the U.S., MediciNova plans to seek a marketing partner for MN-221. About the U.S., he says the company will consider collaborating with a partner and maintaining a role in further development and commercialization.
"The major market opportunity is focused in larger hospitals, which can be cost-effectively supported with a focused hospital sales force."
At the end of 2011, MediciNova had $15.1 million in cash, including $10 million raised last year in equity and non-dilutive funding from Kissei Pharmaceutical, representing a cash runway into 2013 for MediciNova.
"We're not up against the gun to make decisions," Mr. Coffee says. "We have the time to do the right things, such as work with our advisors, do an end-of-Phase II meeting with the FDA and select the appropriate strategy for advancing the MN-221 Phase III program."