Array BioPharma has reported positive results from a Phase II trial of an oral CRTh2 antagonist, ARRY-502, for mild to moderate persistent allergic asthma.
In the placebo-controlled, randomised trial, ARRY-502 met the primary endpoint by demonstrating 6.8% improvement in forced expiratory volume in one second (FEV1) compared to placebo in pre-specified Th2 biomarker subset representing half of treated patients.
In the double-blind trial, which also met key secondary endpoints, ARRY-502 was dosed at 200mg twice daily (N = 93) for four-week period and was well tolerated with fewer adverse events compared with placebo.
Secondary efficacy endpoints, where the investigational agent achieved statistical significance, are 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 and improvement in rhinasthma and asthma quality of life questionnaires (AQLQ).
University of Pittsburgh Asthma Institute director and trial lead investigator Dr Sally Wenzel said: “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.”
A total of 184 patients with mild-to-moderate persistent allergic asthma from US were enrolled in the study.
ARRY-502 improved FEV1 by 3.9% compared with placebo (N = 91), achieving statistical significance, according to the data.
The study noted low overall frequency of adverse events in the ARRY-502 group compared to the placebo group without any treatment-emergent serious adverse events in patients receiving ARRY-502.
Array chief executive officer Ron Squarer said: “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.”
Image: Asthma, obstruction of the lumen of the bronchiole by mucoid exudate, goblet cell metaplasia, epithelial basement membrane thickening and severe inflammation of bronchiole. Photo: courtesy of Yale Rosen.