MediciNova Misses Primary Goal in Mid-Stage Trial of IV Asthma Drug

It was clear that San Diego’s MediciNova had a lot riding on the outcome of a mid-stage trial of the company’s lead drug candidate, bedoradrine sulfate. As I reported recently, MediciNova has been developing the compound to treat acute asthma attacks that are not responsive to standard therapy.

So shareholders registered their disappointment in preliminary results that MediciNova released today after regular Nasdaq trading ended - sending shares of MediciNova down by roughly 50 percent in after hours trading. Less than two hours after the news hit the wires, MediciNova’s shares were trading around $1.40, after falling by $1.35, or 49 percent, from $2.75 a share.

Many investors probably didn’t read much 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. In other words, patients who got the drug did no better in exhaling for one second than patients who got a placebo. Yet bedoradrine showed a significant improvement in other ways over the placebo group as well as patients who only received the current standard of care. MediciNova says its drug also reduced hospital admissions in acute asthma cases, and no significant safety or tolerability issues were seen.

Shareholders were likely expecting to see “home-run data,” MediciNova CEO Yuichi Iwaki told me by telephone late this afternoon. “We put the fact that we did not meet primary end point at the beginning,” he said. “If you read through everything, we clearly indicate that the trial was positive, and we’re ready to move onto Phase 3.”

Iwaki 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due to protocols that called for giving patients a two-hour intravenous infusion, which he says were based on an outdated trial design.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.

In a statement from MediciNova, Iwaki says, “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.”

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Bruce V. Bigelow is the editor of Xconomy San Diego