Critical Therapeutics completes trial of asthma drug

Dosing was initiated in February 2006 and Critical Therapeutics expects to report preliminary results from this trial later this quarter. The company is developing zileuton IV initially for use in patients who suffer acute exacerbations of asthma.

The phase I/II clinical trial of zileuton IV is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients. Patients dosed in the study had a baseline lung function of 40% to 80% of predicted normal, as measured by FEV1 (forced expiratory volume). This trial is the first time an IV formulation of a 5-lipoxygenase inhibitor has been tested in humans.

Patients enrolled in the study were randomized into four escalating dose groups, each receiving one infusion of either zileuton IV or placebo. Lung function measurements were taken prior to dosing and at additional times during the 24-hour period after the infusion. All patients participated in a three-day follow-up period post-infusion, primarily to assess the safety of zileuton IV.

Zileuton inhibits 5-lipoxygenase (5-LO) the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion.