Neurogen Corporation, a small molecule drug discovery and development company, announced top-line results from its Phase IIa clinical trial for asthma using NGD 2000-1, the first oral C5a antagonist to be tested in humans for the treatment of asthma. In this exploratory trial, designed to evaluate the potential benefit of blocking the C5a receptor in patients with mild to moderate asthma, NGD 2000-1 did not demonstrate a therapeutic benefit with respect to predetermined endpoints.
William Koster, PhD, president and CEO of Neurogen said, "We're disappointed that blocking the C5a receptor did not appear to provide a therapeutic benefit in the asthma study. Asthma is a complex disorder with a heterogeneous mix of disease processes. In the coming months we will analyze the data from the study to determine if any subset of patients showed benefits that should be explored further."
Dr Koster continued, "In our broader portfolio of programmes we have made outstanding progress last year. In the year ahead, we expect results of Phase IIa studies in rheumatoid arthritis and further Phase I results from Pfizer on our collaborative insomnia programme. In addition, we expect to capitalize on the substantial advancements we have made in our pain programme, recently partnered with Merck, our depression/anxiety programme partnered with Aventis, and our unpartnered obesity programme."
The safety, pharmacokinetics, and efficacy of NGD 2000-1 for treatment of asthma were assessed in a randomized, double-blind, placebo controlled study of patients with mild to moderate asthma. The trial encompassed 142 patients in 16 clinical centers. Patients were dosed for 28 days with either placebo, 10 mg, 60 mg, or 100 mg of NGD 2000-1, twice daily. The primary endpoint for the trial measured Forced Expiratory Volume in one second (FEV-1), the most frequently used lung function index for assessing bronchoconstriction or bronchodilatation in asthmatics. Secondary endpoints included an assessment of disease signs and symptoms and the use of albuterol, a common rescue medication used by asthma patients.