MediciNova's MN-001 increases lung capacity in asthma patients during phase 2 trial

By Angela McDaniels

Seattle, Dec. 14 - MediciNova Inc. said its MN-001 significantly improved measures of respiratory function in asthma patients compared to placebo during a phase 2 trial.

MN-001, a small molecule inhibitor of inflammatory mechanisms known to be involved in asthma, was evaluated in a randomized, double-blind, placebo-controlled multi-center phase 2 clinical trial in 147 patients with mild-to-moderate asthma.

Patients were randomly assigned to receive placebo or MN-001 tablets in one of three oral dosing regimens: 500 mg three times daily, 750 mg twice a day or 750 mg four times a day.

The primary endpoint of the trial was achieved with a statistically significant improvement in mean forced expiratory volume in one second after four weeks of treatment with 500 mg of MN-001 compared to placebo, the company said. A similar trend was observed for the 750 mg twice daily dose.

Positive trends in secondary outcome measures were also observed in the 500 mg treatment group, including serial spirometry, morning and evening peak flow rates and PC20 values in a methacholine challenge test, common measures of respiratory function.

MN-001 was well tolerated in this trial with 89% of patients completing treatment, the company said. There was no apparent difference between placebo and any of the active treatment groups in adverse events.

"The results of this trial suggest that MN-001 may be an effective oral treatment for asthma that could offer a new approach to treating a complex, multi-modal disease that affects up to 300 million people worldwide," chief development officer Richard E. Gammans said in a company news release.

"We are delighted to take this important step in the validation of our business model by achieving proof-of-concept in our first clinical program," executive chairman and acting chief executive officer Yuichi Iwaki said in the release.

MediciNova is a pharmaceutical company based in San Diego with a pipeline of compounds targeting cancer, asthma, generalized anxiety disorder, multiple sclerosis, interstitial cystitis, preterm labor and urinary incontinence.

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