US-based Eleven Biotherapeutics has started patient randomisation and dosing in its Phase III OASIS clinical trial of EBI-005 for the treatment of moderate to severe dry eye disease (DED).
OASIS is a multi-centre, double-masked, randomised, controlled, efficacy and safety trial that is evaluating EBI-005 5mg/mL topical ophthalmic solution versus vehicle control in subjects with moderate to severe DED.
The company's most advanced product candidate, EBI-005 is a novel, topically administered Interleukin-1 (IL-1) receptor blocker being developed for the treatment of DED and allergic conjunctivitis.
It was designed, engineered and generated using the company's AMP-Rx platform, a powerful and versatile platform that rapidly and efficiently delivers proteins which have been optimised to meet predefined specifications by simultaneously tuning in multiple characteristics.
EBI-005 was designed to bind and block the IL-1 receptor to prevent transmission of biological signals that are responsible for many of the signs and symptoms of ocular surface diseases.
Around 650 patients will be enrolled in the trial and randomised to receive EBI-005 or a vehicle-control.
Co-primary endpoints of the trial are change in corneal fluorescein staining score (a sign of DED) and improvement in pain and discomfort (a symptom of DED).
Safety and tolerability of EBI-005 compared with vehicle-control will also be evaluated in the Phase III study.
Based on estimates of patient enrolment, the company expects the top line data from the Phase III trial to be available in early 2015.
The Phase III trial was designed based on the results of the company's Phase Ib/IIa clinical trial of EBI-005 in patients with moderate to severe DED.
The EBI-005 programme is based on the role that elevated levels of the inflammatory cytokine interleukin-1, or IL-1, play in the start and maintenance of the inflammation and pain associated with DED and the redness and itching associated with allergic conjunctivitis.