Evolutec terminates rEV131 in allergic rhinitis

UK drugmaker Evolutec has discontinued rEV131 in allergic rhinitis after a quality assurance review of its recently-conducted allergic rhinitis clinical trial confirmed that the drug product and the implementation of the protocol were as specified. In the study, the agent failed to meet its primary endpoint: no significant difference was seen in the level of autoimmune inflammation between the drug-treated and placebo groups.

According to Evolutec, the recent Phase IIb trial represented a higher hurdle, with patients being exposed to much greater levels of ragweed pollen than in the previous Phase IIa study. As a result, patients showed twice the allergic symptom score than in the previous trial. Thus the lack of efficacy observed may well have been because the amount of histamine released exceeded the binding capacity of rEV131.