MediciNova to move into Phase 3 program
MediciNova (NASDAQ:MNOV; OSE:4875) has filed a request for an end-of-Phase 2 meeting with the FDA and intends to move forward with Phase 3 clinical development of its MN-221 drug candidate for acute exacerbations of asthma, even though preliminary results from a hospital emergency department-based Phase 2b clinical trial did not statistically meet its primary endpoint of Forced Expiratory Volume in One Second (FEV1), compared with placebo.
However, the company said MN-221 showed a “significant benefit over placebo for FEV1 (liters) Area Under the Curve (AUC Hour 0-1, 0-2, 0-3) of change from baseline.”
The trial also demonstrated a reduction in hospital admissions with MN-221 added to standard drug treatments, MediciNova said, adding that there was a significant improvement in clinical symptoms with MN-221 treated patients and the safety profile of MN-221 continues to be positive.
“Although we did not realize statistical significance in our pre-defined primary endpoint, MN-221 displayed the positive efficacy and safety data we expected to see,” CEO Dr. Yuichi Iwaki said in a statement.
“We believe certain variables, such as administration of off-protocol therapies, especially in the standard-of-care alone group (placebo arm) and somewhat higher-than-anticipated variability in measuring FEV1 values limited the MN 221 outcomes,” he added. “Our goal is to control these variables going forward, enabling us to run a successful Phase 3 program.”
MediciNova intends to design pivotal trial(s) that will include “technological and operational improvements and further controls for medications that are not typically used in the treatment of acute exacerbations of asthma and were over-represented in the standard-of-care only group in this study.”
Acute asthma exacerbations, which are asthma attacks not controlled by a patient’s medications, represent a major cause of ER visits and hospitalizations for many of the 26 million people with asthma in the U.S.
Lead investigator, Dr. Lawrence Lewis, said there is clearly an unmet need for more effective treatments for the emergency care of this condition. “We are very pleased that MediciNova will continue development of MN-221 to address this unmet medical need,” he added.