Eleven Biotherapeutics - First Patients Dosed with EBI-005 in Phase III Study in Patients with Moderate to Severe Allergic Conjunctivitis

Eleven Biotherapeutics has announced dose administration for the first patients in a Phase III study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis. This Phase III study was designed and initiated following the completion in October 2014 of a Phase II study in which EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis. This included statistically significant improvements in mean change from baseline in patient reported ocular itching, tearing and associated nasal symptoms compared to vehicle-control at the second to last and final assessment time points following allergen exposure in a modified direct conjunctival allergen provocation test (CAPT) model.

“Patient dosing in this Phase III study represents a significant step forward in the clinical development of EBI-005, a drug candidate with potential for the treatment of moderate to severe allergic conjunctivitis patients who are refractory to standard of care treatments for ocular allergy,” said Abbie Celniker, CEO of Eleven Biotherapeutics. “We look forward to reporting top line data from this Phase III study in the first quarter of 2016.”

“Many allergic conjunctivitis patients develop a late-phase severe allergic response which is not treated with antihistamines or mast cell stabilizers, the current standard of care. The ocular itching, tearing, redness and other symptoms, which if left untreated can become severe, resulting in chronic ocular pain, corneal scarring and distortion of vision. Currently, many of these patients are treated with topical steroids, which have a number of adverse side effects, including increased intraocular pressure and cataract formation,” said Dr Victor Perez, Professor of Ophthalmology at Bascom Palmer Eye Institute. “EBI-005 offers the potential to mediate this late-phase allergic response by blocking the interleukin-1 (IL-1) receptor, believed to be responsible for the symptoms of ocular surface inflammation in diseases like allergic conjunctivitis, with an acceptable, long-term safety and tolerability profile.”

This multi-center, double-masked, randomized, vehicle controlled Phase III pivotal trial is designed to evaluate the safety and efficacy of EBI-005 for up to 4 weeks in patients with moderate to severe allergic conjunctivitis in an environmental setting. Approximately 250 patients will be randomized 1:1 to receive treatment with EBI-005 or with vehicle. If the results of this first Phase III trial are favorable, Eleven intends to initiate a second Phase III trial in the second half of 2016.