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ARTICLE | Clinical News

OC459: Phase IIb data

March 10, 2014 7:00 AM UTC

A double-blind, international Phase IIb trial in 482 patients with mild to moderate persistent asthma showed that 25 mg once-daily oral OC459 met the primary endpoint of significantly increasing mean FEV1 from baseline to week 17 vs. placebo (162 vs. 57 mL, p=0.028). The 100 mg twice-daily (149 mL, p=0.068) and 200 mg once-daily (136 mL, p=0.128) doses of OC459 missed the primary endpoint vs. placebo. On secondary endpoints, the proportion of patients achieving an improvement in total ACQ score from baseline to week 17 >=minimally important difference (MID) was significantly greater in the pooled OC459 groups vs. placebo (50.8% vs. 33%, p=0.001). The proportion of patients achieving an improvement in total AQLQ score from baseline to week 17 >=MID was significantly greater in the pooled OC459 groups vs. placebo (54.2% vs. 37.4%, p=0.002). According to the American Thoracic Society, the MID is 0.5 points for both endpoints. OC459 significantly reduced the incidence of respiratory tract infection to 12.9% in the 25 mg arm, 13.7% in the 100 mg arm, 10.6% in the 200 mg arm and 12.3% in the pooled arm vs. 23.1% in the placebo arm (p<0.05 for all).

In a subgroup of patients with uncontrolled, eosinophilic asthma, each dose of OC459 significantly improved mean FEV1 from baseline to week 17 compared to placebo. The placebo-adjusted improvement was 220 mL in the pooled OC459 groups (n=104) compared to placebo (n=37; p=0.005). In eosinophilic patients ages <=40, the improvement was 355 mL in the pooled OC459 groups compared to placebo. Data were presented at the American Academy of Allergy, Asthma and Immunology meeting in San Diego. ...