Array BioPharma announces positive results from ARRY-502 Phase 2 trial for allergic asthma

Array BioPharma Inc.Jul 23 2013

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.

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 frequency of adverse events was lower in the ARRY-502 group including fewer asthma exacerbations versus the placebo group. There were no treatment-emergent serious adverse events in patients receiving ARRY-502; all treatment-related adverse events were either mild or moderate in severity. A total of 15 (11 in the placebo group, 4 in the ARRY-502 group) out of 184 patients discontinued the study early, primarily due to exacerbations of asthma (5 in the placebo group, 1 in the ARRY-502 group).

"There remains a significant need for more convenient, safe and effective therapies for patients with persistent allergic asthma," said Sally Wenzel M.D., Professor of Medicine and Director of the Asthma Institute at the University of Pittsburgh and lead investigator of this trial. "ARRY-502 is the first oral non-steroidal drug since Singulair® (montelukast) to demonstrate clinically meaningful activity in allergic asthma and represents a potential new oral therapy that may meet these needs."

Ron Squarer, Chief Executive Officer of Array, noted, "With many asthma patients poorly controlled on currently available therapies, a drug targeting a novel, non-overlapping mechanism may present an important new option for millions of patients. We are seeking an appropriate partner to develop ARRY-502 to its full potential."