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ARRY-502 Meets Primary And Key Secondary Endpoints In Asthma Study
Date:7/23/2013

BOULDER, Colo., July 23, 2013 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) today announced positive results from a placebo-controlled, randomized, double‑blind Phase 2 trial in mild to moderate persistent allergic asthma for ARRY-502, an oral CRTh2 antagonist.  ARRY-502 achieved the primary endpoint, significant improvement in pre-bronchodilator Forced Expiratory Volume in one second (FEV1), a measure of lung function.  ARRY-502 was well tolerated with fewer adverse events compared to placebo.  These positive results support continued development of ARRY-502 in allergic asthma.  Array is seeking a partner to further develop ARRY-502 in this large market.

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The proof-of-concept study enrolled 184 patients in the United States with mild-to-moderate persistent allergic asthma, a population which represents more than 12 million patients in the U.S.  ARRY-502, dosed at 200 mg twice daily (N = 93) for 4 weeks, improved FEV1 by 3.9% versus placebo (N = 91), achieving statistical significance (P = 0.02).  A predefined endpoint using the median baseline value of a Th2 associated biomarker was also evaluated. Patients in this population achieved enhanced improvement in FEV1 (6.8 % versus placebo, P = 0.008). 

Secondary efficacy endpoints also achieved statistical significance including:

  • Reduced short-acting beta agonist (SABA) use 
  • Asthma control as measured by the Asthma Control Questionnaire (ACQ)
  • Forced Vital Capacity (FVC) improvement  
  • Symptom free days during treatment
  • Improvement in Rhinasthma and Asthma Quality of Life questionnaires (AQLQ)
  • The overall fr
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    SOURCE Array BioPharma Inc.
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