Critical Therapeutics says zileuton IV improves lung function

By Elaine Rigoli

Tampa, Fla., Aug. 23 - Critical Therapeutics, Inc. said patients showed improvement during the company's phase 1/ 2 clinical trial designed to evaluate safety, tolerability and pharmacokinetics of the intravenous formulation of zileuton (zileuton IV) in patients with asthma.

In addition, the trial included measurements to detect evidence of improvement in lung function. The double-blind, placebo-controlled trial enrolled 60 patients at 10 clinical sites in the United States.

Patients enrolled in the trial had a mean FEV(1) (forced expiratory volume in one second) of 63% of predicted normal at baseline and a mean age of 40 years.

The company said patients enrolled in the trial were randomized into four escalating dose groups (75 mg, 150 mg, 300 mg and 600 mg), each receiving one infusion of either zileuton IV or a placebo.

Each of the four dose groups enrolled 15 patients, of whom 12 received zileuton IV and three received a placebo. All 60 patients who were randomized completed the trial.

The company said patients in each of the four zileuton IV cohorts showed a greater mean percentage improvement in FEV(1) than patients in the placebo group when measured at 10, 30 and 60 minute intervals after dosing.

Critical Therapeutics is developing zileuton IV initially for use in emergency room or urgent-care centers for patients who suffer acute exacerbations of asthma.

Lexington, Mass.-based Critical Therapeutics is a biopharmaceutical company focused on the development of products for respiratory, inflammatory and critical-care diseases.

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