Neurogen Reports Phase IIa Clinical Trial Results for Oral Asthma Drug
Tuesday January 13, 7:15 am ET
BRANFORD, Conn., Jan. 13 /PRNewswire-FirstCall/ -- Neurogen Corporation (Nasdaq: NRGN - News), a small molecule drug discovery and development company, today 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 H. 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 programs we have made outstanding progress in the last year. In the year ahead, we expect results of our Phase IIa studies in rheumatoid arthritis and further Phase I results from Pfizer on our collaborative insomnia program. In addition, we expect to capitalize on the substantial advancements we have made in our pain program, recently partnered with Merck, our depression/anxiety program partnered with Aventis, and our unpartnered obesity program."
Clinical Protocol
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.
Webcast
A conference call and webcast to discuss today's announcement will be held by Neurogen today, January 13, 2004 at 9:00 a.m. EST. The live webcast will be available in the Investor Relations section of www.neurogen.com and will be archived in the "Events Calendar & Past Event Replays" area of that section. A replay of the conference call will be available after 11:00 am EST on January 13, 2004 and accessible through the close of business January 31, 2004. To replay the conference call, dial 888-286-8010, or for international callers 617-801-6888, and use the passcode 42547844. |
