MediciNova, Inc. (MNOV) reported yesterday that preliminary results from a hospital emergency department (NYSE:ED)-based Phase 2b clinical trial evaluating its MN-221 in patients with acute exacerbations of asthma did not statistically meet the primary endpoint, improvement in FEV1 (Forced Expiratory Volume in One Second) compared to placebo.
MediciNova's stockholders clearly reacted on these disappointed results: MNOV shares have been sending down by roughly 50 percent.
Is anything missing here? Let us review the MediciNova's press release beyond the first sentence, which says the Phase 2b trial did not statistically meet the primary endpoint, improvement in forced expiratory volume (FEV1), compared to a placebo.
However, 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 (p=0.043, p=0.050, p=0.066 respectively) in the data set defined below. The trial also demonstrated a reduction in hospital admissions with MN-221 added to standard drug treatments. Moreover, there was a significant improvement in clinical symptoms with MN-221 treated patients and the safety profile of MN-221 continues to be positive as no safety/tolerability issues of clinical significance were observed.
Are you following us? Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, says the failure to meet the primary goal of the mid-stage trial was probably due to protocols that called for giving patients a two-hour intravenous infusion, which were based on an outdated trial design. The company has maintained that its drug poses a key advantage over the current standard of care in U.S. emergency rooms, which typically use an inhaled drug like albuterol, because constricted airways limit how much aerosol can be absorbed. As an IV drug, doctors have a better understanding of how much bedoradrine a patient has absorbed.
Are you still following us? Dr. Iwaki final comment:
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 [bedoradrine] outcomes. Our goal is to control for these variables going forward, enabling us to run a successful Phase 3 program. Accordingly, we have filed our End-of-Phase 2 meeting request with the Division of Pulmonary, Allergy, and Rheumatology Products at FDA
Stock bounce is imminent.
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MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a commercial focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential, and patent coverage of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders.