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Novel CRTH2 Antagonist Shows Potential in Moderate Persistent Asthma: Presented at ERS By Evelyn Harvey VIENNA, Austria -- September 18, 2009 -- A novel compound that acts on the CRTH2 receptor improved lung function and quality of life in a phase II study of patients with moderate persistent asthma, according to researchers here at the 19th Annual Congress of the European Respiratory Society (ERS). This is the first demonstration of efficacy of a CRTH2 antagonist in asthma. Neil Barnes, MD, The London Chest Hospital, Barts and the London NHS Trust, London, United Kingdom, presented the results on September 15. The CRTH2 receptor is expressed on TH2 lymphocytes, eosinophils, and basophils. The compound OC000459 was developed as a novel CRTH2-targeting anti-inflammatory. Animal studies indicate that the reduction in airway inflammation is achieved primarily via a decrease in eosinophil recruitment. Prior proof-of-concept studies of OC000459 have demonstrated its efficacy in allergic rhinitis, and the drug is well tolerated at doses up to 400 mg. The trial was conducted in health centres in Moscow and St Petersburg, where 132 subjects with mild-moderate persistent atopic asthma (as per the Global Initiative for Asthma) were recruited and randomised. After a 2-week placebo run-in, OC000459 (n = 65) or placebo (n = 67) was given for 4 weeks, with a subsequent placebo washout period of 2 weeks. Although the half-life of OC000459 is 12 to 15 hours, a twice-daily dose of 200 mg was used in this study. Baseline characteristics were similar, with only nonsmokers recruited. The only concomitant treatments permitted were short-acting beta2-agonists such as salbutamol. Missing spirometry data or other confounding factors led to the exclusion of 10 OC000459 and 15 placebo subjects from the per-protocol analysis. In the per-protocol population, forced expiratory volume in 1 second (FEV1) increased by a mean of 9.2% (214 mL) from baseline in the OC000459 treatment group, which was 7.4 % (184 mL) greater than the increase in FEV1 in the placebo group (P = .037). A significant improvement was also seen in clinic peak expiratory flow with OC000459 (P = .009). Scores in a validated quality-of-life measurement increased significantly from baseline with OC000459 compared with placebo (P = .011). Further significant decreases in serum immunoglobulin E (P = .033) and sputum eosinophil count (P = .03) were observed in the OC000459-treated arm relative to the placebo arm. No serious adverse events were associated with OC000459 treatment. Rates of adverse events and numbers of withdrawals were similar across the treatment groups. “OC000459 shows an improvement in several asthma measures when compared with placebo,” concluded Dr. Barnes. “Since FEV1 increase did not plateau by 4 weeks, there is scope for potential further improvement with longer-term therapy.” The researchers concluded that the CRTH2 antagonist OC000459 shows promise as a therapeutic option for asthma patients, based on results from the first phase II clinical trial. Further trials are needed to determine dose response and demonstrate efficacy in a larger population. Funding for this study was provided by Oxagen. [Presentation title: A Randomised, Double-Blind, Placebo-Controlled Study of the CRTH2 Antagonist OC000459 on Moderate Persistent Asthma. Abstract 3267] E-mail this page to a friend or colleague! To print, use this version