Eleven Biotherapeutics Phase 2 Trial Of EBI-005 Misses Primary Endpoint

(RTTNews) - Eleven Biotherapeutics, Inc. (EBIO) Thursday said its Phase 2 trial evaluating drug candidate EBI-005, in patients with moderate to severe allergic conjunctivitis, did not meet its primary endpoint of reduction in mean ocular itching in patients compared to vehicle-control, in the Environmental Exposure Chamber Model. The trial was conducted using two distinct repetitive allergen challenge models: a modified Conjunctival Allergen Provocation Test or CAPT model; and a modified Environmental Exposure Chamber or EEC model. However, it was found that EBI-005 was generally well-tolerated, with no treatment-related serious adverse events and no immunogenicity detected. In the CAPT model, patients treated with EBI-005 showed statistically significant improvements in mean change from baseline in patient reported ocular itching compared to vehicle-control, one of the secondary endpoints pre-specified in the statistical analysis plan. The study was designed to identify an appropriate model of late phase ocular allergy response and to evaluate the safety and efficacy of EBI-005 in patients with moderate to severe allergic conjunctivitis.