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news.Expected to enroll approximately 200 patients at approximately 35 emergency department clinical sites
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MediciNova and the Hercules Market of the Osaka Securities Exchange have reported final results from its Phase II clinical trial evaluating MN-221 at planned escalating doses of 240 to 1,080mcg in patients with severe, acute exacerbations of asthma treated in emergency departments.
The study included 29 patients with severe, acute exacerbations of asthma. All patients received standardized care consisting of inhaled albuterol, ipratropium and oral steroid treatment. No safety concerns with adding MN-221 to standardized care were identified following review of electrocardiogram (ECG), laboratory and adverse experience data, the company said.
The hospitalization rate among patients treated with standardized care only was 46% (six of 13), which was the anticipated rate, compared to a hospitalization rate of 25% (four of 16) among patients receiving MN-221 plus standardized care. This represents a 45% reduction in hospitalization rate among patients treated with MN-221. All hospitalizations were due to asthma exacerbations which were judged to be unrelated to study medication and therefore do not raise safety concerns for adding MN-221 to standardized care.
As specified in the protocol for this clinical trial, no inferential statistics (i.e., p-values) were calculated for this study. Improvement in forced expiratory volume in one second (FEV(1)) values generally appeared to be greater for patients receiving MN-221 in addition to standardized treatment.
MediciNova also announced that its MN-221-CL-007 study, a randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the safety and efficacy of MN-221 in patients with severe, acute exacerbations of asthma, has begun enrolling patients in the US. The majority of investigators who participated in the MN-221-CL-006 study have rolled over to the MN-221-CL-007 study.
MediciNova expects to enroll approximately 200 patients at approximately 35 emergency department clinical sites, including the clinical sites rolled over from the MN-221-CL-006 study, in North America, Australia and New Zealand. The MN-221-CL-007 study is designed to compare standardized care to standardized care plus MN-221 at a dose of 1.2mg administered over one hour.
Patients enrolled in the study will continue to receive standardized care as needed while receiving an intravenous infusion of MN-221 or placebo. The primary efficacy endpoint will be improvement in FEV(1). Enrollment of study participants began in April 2009 in the North American clinical sites and is anticipated to begin by June 2009 in the Australia and New Zealand clinical sites. Enrollment is expected to be complete within nine to 12 months.
Yuichi Iwaki, president and CEO of MediciNova, said: These clinical results are consistent with the interim data reported from this study in January 2009 and demonstrate the potentially beneficial effect of MN-221 in the treatment of severe, acute exacerbations of asthma. The benign safety profile of MN-221 and the 45% reduction in hospitalization rate observed are encouraging.