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ARTICLE | Clinical News

Atopix reports mixed Phase II asthma data

March 4, 2014 1:58 AM UTC

One dose of OC459 from Atopix Therapeutics Ltd. (London, U.K.) met the primary endpoint while two other doses missed in a Phase IIb trial to treat mild to moderate persistent asthma. In the trial, 25 mg once-daily oral OC459 met the primary endpoint of significantly increasing mean percent predicted force expiratory volume in one second (FEV1) from baseline to week 17 vs. placebo (162 vs. 57 mL, p=0.128). The 100 mg twice-daily (149 mL, p=0.068) and 200 mg once-daily (136 mL, p=0.024) doses of OC459 missed the endpoint vs. placebo. The double-blind, international trial enrolled 482 patients. Data were presented at the American Academy of Allergy, Asthma and Immunology meeting in San Diego.

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 improvement was 220 mL in the pooled OC459 groups (n=104) compared to placebo (n=37; p=0.005). In eosinophilic asthma patients 40 years of age and younger, the improvement was 355 mL in the pooled OC459 groups compared to placebo. OC459 is a prostaglandin D2 (PGD2) receptor subtype DP2 (PTGDR2) (CRTH2) (GPR44) (DP2) antagonist. ...