MediciNova's ($MNOV) shares crashed after the San Diego-based biotech said its Phase IIb study of an acute asthma drug failed to hit the primary endpoint. And while the CEO tried to put the data in context, offering reasons for optimism for a planned late-stage study of the lead program, investors watched the stock price crater more than 50% after the news hit.
"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," said Yuichi Iwaki, M.D., Ph.D., president and CEO of MediciNova. "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. Our goal is to control these variables going forward, enabling us to run a successful Phase III program. Accordingly, we have filed our End-of-Phase II meeting request with the Division of Pulmonary, Allergy, and Rheumatology Products at FDA."
Investigators in the study say that the patients taking the asthma medication experienced an improvement in lung function, reducing hospitalizations in the study, which was undertaken in hospital emergency departments. And they add that they can design a pivotal study that can exclude the variables they believe scuttled their study.
- here's the press release