Biopharmaceutical firm Eleven Biotherapeutics has reported encouraging clinical data for EBI-005, the first IL-1 (Interleukin-1) signaling inhibitor intended for topical ocular administration, at the 7th International Conference on Tear Film & the Ocular Surface (TFOS) in Taormina, Sicily.
The data showed positive results of EBI-005 in Phase Ib/IIa clinical trial and its dual action on treating both the signs and symptoms of dry eye disease (DED ).
The Phase Ib/IIa clinical trial, a double-masked, multi-centre, randomised, placebo-controlled, environmental study, enroled 74 subjects throughout the US.
The study, which was designed to assess the biologic activity of EBI-005 on the signs and symptoms of dry eye disease as compared with baseline and to the placebo (vehicle) control, evaluated two doses of EBI-005 over a six-week period in subjects with moderate to severe dry eye disease.
Determination of the safety and tolerability of EBI-005 at two doses compared to the placebo (vehicle) control was the primary objective of the study.
Eleven Biotherapeutics CEO Abbie Celniker said EBI-005 is a new mechanism for treating dry eye disease that targets therapy with highly selective blockade of the inflammatory cytokine IL-1, a central driver for signs and symptoms of DED.
"These data provide clear evidence of EBI-005’s dual action resulting in significant improvement in both the inflammation and pain/discomfort associated with dry eye disease," Celniker said.
Eleven Biotherapeutics researchers presented the clinical data in an oral poster presentation entitled ‘Use of Novel IL-1 Receptor Inhibitor (EBI-005)in the Treatment of Patients with Moderate to Severe Dry Eye Disease’.
The data showed that patients treated with EBI had significant improvement in signs (corneal fluorescein staining/CFS) (by 33%) and symptoms (Ocular Surface Disease Index/OSDI, individual patient symptom assessments, and investigator global assessments) (by 36%) from baseline compared to the vehicle control treated patients.
During the trial, EBI-005 treated subjects used significantly less rescue artificial tears than those subjects receiving vehicle control (p=0.032).
According to the company, there was no difference in the safety profile of EBI-005 treated subjects compared to the vehicle control treated subjects, and no serious adverse events were reported.
Eleven Biotherapeutics head of Medical Research Michael Goldstein said the results support the upcoming 12-week multi-centre pivotal study designed to confirm the activity of EBI-005 in patients with DED and provide encouraging data to investigate EBI-005 for additional ocular surface conditions mediated by IL-1 such as ocular allergy.
"EBI-005 had a positive effect on signs and symptoms of all moderate to severe DED patients treated in the study," Goldstein said. "Based on these data, we identified a subset of patients who demonstrated an even more robust improvement from vehicle which will be explored in future clinical studies."
EBI-005 was found to be generally safe, well-tolerated, and showed statistically significant improvements in signs and symptoms of dry eye disease when compared to baseline in its previous clinical study.
According to the company, EBI-005 has optimal physical, pharmaceutical and therapeutic properties, including topical ophthalmic administration, for the treatment of ocular diseases including dry eye and severe ocular allergy.
The company will use the data secured from these trials to advance EBI-005 into a pivotal efficacy and safety, multi-centre clinical trial in DED patients.
DED is an ocular surface inflammatory condition induced by desiccating stress and mediated by an inflammatory cascade regulated by IL-1.
Around 10% of individuals between 30 to 60 years of age and around 15% of those over 65 of age are affected by DED.