Eleven Biotherapeutics Presents Clinical Data on EBI-005 for the Treatment of Dry Eye Disease and Allergic Conjunctivitis

Eleven Biotherapeutics, Inc.

, a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the presentation of clinical data for EBI-005, its novel, protein therapeutic which is in late-stage clinical development for dry eye disease and allergic conjunctivitis, at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting. Clinical data on Eleven's lead drug candidate, EBI-005, the first IL-1 (Interleukin-1) receptor inhibitor designed for topical ocular administration, demonstrated a clinically relevant effect in dry eye disease and clinically relevant, statistically significant improvements in ocular itching, ocular tearing and nasal symptoms associated with the late phase allergen response utilizing a modified direct conjunctival allergen model in patients with allergic conjunctivitis. "We are pleased with these data, which further support the important role of interleukin-1 as a key target for ocular surface inflammation, offering a potential new therapy for the treatment of dry eye disease and allergic conjunctivitis," said Abbie Celniker, PhD, President and Chief Executive Officer of Eleven Biotherapeutics. "We are looking forward to reporting top-line pivotal Phase 3 results for EBI-005 in dry eye disease later this quarter and initiating a Phase 3 study with EBI-005 in allergic conjunctivitis in the second half of this year." In an oral presentation entitled, "Comparison of Two Clinical Repeat Allergen Challenge Models to Evaluate EBI-005 in the Late Phase Inflammatory Response in Allergic Conjunctivitis," Michael H. Goldstein, MD, Chief Medical Officer of Eleven Biotherapeutics presented data from a Phase 2 study in subjects with moderate to severe allergic conjunctivitis in which EBI-005 was evaluated in two different clinical models adapted for the late phase inflammatory response, an area of high unmet need and the allergic conjunctivitis patient population for which EBI-005 is being developed. Based on these data, EBI-005 will be evaluated utilizing a natural environment model in a planned Phase 3 allergic conjunctivitis study of EBI-005 in the second half of this year. Highlights of the presentation include: EBI-005 demonstrated clinically relevant, statistically significant improvement in multiple symptoms associated with late phase allergen response in a modified direct conjunctival allergen model Clinically relevant improvements in ocular itching compared with vehicle in a modified direct conjunctival allergen model at the final two efficacy time points In a poster presentation entitled, "Clinical Development of EBI-005, a Novel Interleukin-1 Receptor Inhibitor, for Patients with Ocular Surface Inflammation," Eleven Biotherapeutics researchers describe how data related to dosing, disease severity, patient selection, and endpoint selection from previously completed clinical studies shaped the design of pivotal, Phase 3 studies for EBI-005 in dry eye disease. Highlights of the poster include: EBI-005 demonstrated an effect in both dry eye disease and allergic conjunctivitis EBI-005 effect relative to vehicle was more apparent in moderate to severe patients with dry eye disease with patient Ocular Surface Disease Index (OSDI) of greater than 23 and less than 50 EBI-005 reduced the need for rescue artificial tear use in dry eye disease EBI-005 is designed to provide a blockade of interleukin-1, a central driver for signs and symptoms of dry eye disease and allergic conjunctivitis. This mechanism is consistent with activity we have seen in two independent dry eye disease studies and in a Phase 2 study in patients with allergic conjunctivitis