Date: 2015-08-12
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Eleven Biotherapeutics (USA - MA)
Product: EBI-005
Action
mechanism: protein. EBI-005 is a novel, topically administered Interleukin-1 (IL-1) receptor blocker designed to bind and block the IL-1 receptor to prevent transmission of biological signals responsible for many of the signs and symptoms of ocular surface diseases. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine IL-1 play in the initiation and maintenance of the inflammation, pain, redness, itching and other symptoms associated with ocular surface diseases. EBI-005 is currently in Phase 3 clinical development for the treatment of moderate to severe allergic conjunctivitis. In a completed Phase 2 clinical trial, EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis in a (CAPT) model.
Disease: moderate to severe allergic conjunctivitis
Therapeutic area: Allergic diseases - Immunological diseases - Ophtalmological diseases
Country: USA
Trial
details: This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks. Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled into the study. (NCT02492321)
Latest
news: * On August 12, 2015, Eleven Biotherapeutics, a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, announced dose administration for the first patients in a Phase 3 study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis. This Phase 3 study was designed and initiated following the completion in October 2014 of a Phase 2 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.This multi-center, double-masked, randomized, vehicle controlled Phase 3 pivotal trial is designed to evaluate the safety and efficacy of EBI-005 for up to four 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 3 trial are favorable, Eleven intends to initiate a second Phase 3 trial in the second half of 2016.
