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news.Critical Therapeutics has announced top-line results from its Phase II clinical trial of the injectable formulation of zileuton, the company's investigational compound for acute asthma in the emergency department.
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A total of 36 evaluable patients with stable chronic asthma were enrolled in the randomized, multi-center, double-blind, Phase II, three-period, crossover trial, which was designed to explore the pulmonary function profiles of subjects after receiving a single dose of zileuton injection compared to placebo in patients who were not experiencing an acute exacerbation of asthma.
To qualify for inclusion in the trial, patients had to have a forced expiratory volume in one second (FEV1) of 40% to 80% of predicted normal and suspend use of some asthma controller medications prior to dosing. Patients were randomized to three treatment periods with two dose levels of zileuton injection (150mg and 300mg) and placebo. Pulmonary function was measured using the variables of FEV1 and peak expiratory flow rate at multiple time points over the first hour then hourly to 360 minutes after dosing.
Patients at each of the two zileuton injection dose levels showed a numerically greater mean percentage improvement in FEV1 from baseline than patients in the placebo group, however, the results were not statistically significant compared to placebo. A greater effect on pulmonary function was achieved at the 150mg dose level of zileuton injection compared with the 300mg dose level or placebo. This mean percentage improvement in FEV1 from baseline was evident from the first measurement time point of 10 minutes after dosing and was maintained for at least 240 minutes.
Exploratory analyses conducted on the study data indicate that patients with lower pulmonary function at baseline (baseline FEV1 ¡Ü 65% of predicted normal) responded better to zileuton treatment. The company believes that these exploratory analyses and the tolerability of zileuton injection may support a clinical trial in an acute population as a potential next step in the development process. The company intends to initiate a process to seek to enter into a collaboration agreement for the future clinical development and commercialization of zileuton injection.