Array BioPharma: ARRY-502 Meets Primary And Secondary Endpoints In Asthma Study

(RTTNews) - Array BioPharma Inc. (ARRY) 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, the company said.

The company said it 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). 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 use; Asthma control as measured by the Asthma Control Questionnaire.

According to the company, 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), the company said.