Efficacy and safety of AMG 853 in asthma: Results of a phase 2, randomized, double-blind, placebo-controlled study (AAAAI 2012) - Feb 15, 2012 - Presentation time: Mar 5 2012; P2, N=352; Although AMG 853 demonstrated no associated risks for subjects, no significant improvements in both Asthma Control Questionnaire (ACQ) scores & prebronchodilator FEV1 from baseline to week 12 were observed vs. PBO
P2 data • Immunology
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#761; 2012 AAAAI (American Academy of Allergy Asthma and Immunology) 68th Annual Meeting, Mar 2-6, 2012
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RATIONALE: AMG 853, an orally bioavailable small molecule that inhibits binding of PGD2 to receptors DP1 and CRTH2, was investigated as treatment for inadequately controlled asthma in this randomized, doubleblind, multiple-dose phase 2 study. Primary objective was to determine the effectiveness of AMG 853 compared with placebo as measured by Asthma Control Questionnaire (ACQ) score change from baseline at week 12. Key secondary endpoint was change in prebronchodilator FEV1 .
METHODS: Adult subjects with percent-predicted FEV1 50280%, inhaled steroids of 20021000mcg/day of fluticasone or equivalent, were randomized 1:1:1:1:1 to receive 5, 25, or 100 mg AMG 853 BID; 200 mg AMG 853 QD; or placebo for 12 weeks. LABA were not allowed during the treatment period. Change in ACQ score was analyzed using Analysis of Covariance (ANCOVA) model.
RESULTS: 352 subjects completed 12 weeks of treatment. At week 12, mean changes from baseline in ACQ scores were -0.541, -0.555, -0.444, -0.498, -0.492 and for percent-predicted FEV1 were 1.462, 1.019, -0.518, 1.288, 0.896 (5 mg, 25 mg, 100 mg, 200 mg, and placebo). BID treatment did not differ from placebo on changes in ACQ and FEV1 (P50.77; P50.34). No subgroup (including segregating by tertiles of baseline ACQ, bronchodilator reversibility, FeNO, ICS dose, blood eosinophilia) demonstrated increased efficacy. No treatment or dose-dependent imbalances in adverse events were observed.
CONCLUSIONS: Although AMG 853 demonstrated no associated risks for subjects, no significant improvements in both ACQ scores and prebronchodilator FEV1 from baseline to week 12 were observed as compared with placebo.
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