Date: 2014-10-01
Type of information: Results
phase: 2
Announcement: results
Company: Eleven Biotherapeutics (USA - MA)
Product: EBI-005
Action
mechanism: 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 use of EBI-005 in allergic conjunctivitis is based on the role that elevated levels of IL-1 play in the initiation and maintenance of the itching and other symptoms associated with late-phase allergic conjunctivitis
Disease: moderate to severe allergic conjunctivitis
Therapeutic area: Allergic diseases - Immunological diseases - Ophtalmological diseases
Country:
Trial
details: The Phase 2 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. To identify the model system that reflects the more severe forms of ocular allergy experienced by allergic conjunctivitis patients, the company conducted a 159-subject, randomized, vehicle-controlled, Phase 2 study enrolling subjects in modified CAPT and EEC models. Unlike the models used for the approval of drugs to treat early phase ocular allergic responses, these models incorporated allergen challenges over multiple consecutive days prior to and during study drug treatment, with disease assessments at multiple time points over the two and one-half week period after commencement of treatment.
Latest
news: * On October 1, 2014, Eleven Biotherapeutics announced top-line results from a Phase 2 study of EBI-005, in patients with moderate to severe allergic conjunctivitis. The company ran this Phase 2 study using two distinct repetitive allergen challenge models: a modified Conjunctival Allergen Provocation Test (CAPT) model; and a modified Environmental Exposure Chamber (EEC) model. 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, at the second to last (p = 0.033) and final (p = 0.045) assessment time points. This Phase 2 study did not meet the primary endpoint of reduction in mean ocular itching in patients treated with EBI-005 compared to vehicle-control in the EEC model. In addition to demonstrating statistically significant improvements in the change from baseline in patient reported ocular itching, a pre-specified secondary endpoint, the subjects with moderate to severe allergic conjunctivitis randomized to the CAPT model who received EBI-005 showed improvements compared to vehicle-control on the pre-specified exploratory endpoints of ocular tearing at the second to last (p = 0.027) and final (p = 0.044) assessments and associated nasal symptoms at the second to last (p = 0.004) and final (p = 0.011) assessment time points. In the EEC model, there were no observed differences between patients treated with EBI-005 and vehicle-control on the endpoints of ocular tearing or associated nasal symptoms; however, there was a significant improvement in pre-specified exploratory endpoint of lid swelling in patients treated with EBI-005 compared to vehicle-control at the second to last (p = 0.011) and final (p = 0.037) assessment time points, which was not seen in the CAPT model. There were no observed differences between patients treated with EBI-005 and vehicle-control on the additional secondary and exploratory endpoints of conjunctival redness, conjunctival chemosis, follicular/papillary response, or mucus discharge in the CAPT or EEC models. The comprehensive results of the study are expected to be submitted for presentation at an upcoming ophthalmology conference. The safety and tolerability of EBI-005 compared to vehicle-control was also evaluated in this Phase 2 study. EBI-005 was generally well-tolerated, with no treatment-related serious adverse events and no immunogenicity detected. Most adverse events observed in the study were mild and similarly distributed between the vehicle-control and EBI-005-treated patients. “The positive result in the CAPT model will help us to determine our path forward with EBI-005 as a potential new treatment option for patients with moderate to severe allergic conjunctivitis, and we have a goal of finalizing our plans early next year. In addition, we are also looking forward to the completion of our first pivotal, Phase 3 clinical study (NCT01998802) of EBI-005 in patients with dry eye disease and to report top-line results of that trial in early 2015.”
