CAMBRIDGE, Mass.--(EON: Enhanced Online News)--Eleven Biotherapeutics, a biopharmaceutical company designing and engineering novel and differentiated protein-based biotherapeutics for ocular diseases, announced today the presentation of data for EBI-005, the first IL-1 (Interleukin-1) signaling inhibitor designed for topical ocular administration, at the 7th International Conference on Tear Film & the Ocular Surface (TFOS) in Taormina, Sicily. Eleven Biotherapeutics researchers presented data that demonstrated positive Phase 1b/2a clinical results with EBI-005 and its dual action on treating both the signs and symptoms of dry eye disease (DED). Based on these results, Eleven Biotherapeutics will advance EBI-005 into a pivotal efficacy and safety, multi-center clinical trial in patients with DED.
“These results support the upcoming twelve-week multi-center pivotal study designed to confirm the activity of EBI-005 in patients with dry eye disease and provide encouraging data to investigate EBI-005 for additional ocular surface conditions mediated by IL-1 such as ocular allergy”
“EBI-005 represents a new mechanism for treating dry eye disease. It is a targeted therapy with highly selective blockade of the inflammatory cytokine IL-1, a central driver for signs and symptoms of dry eye disease,” commented Abbie Celniker, PhD, Chief Executive Officer at Eleven Biotherapeutics. “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.”
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,” Eleven Biotherapeutics researchers presented clinical data which demonstrated that:
- EBI-005 treated patients had significant improvement in signs and symptoms from baseline. Signs improved by 33% and symptoms by 36% (p<0.001).
- EBI-005 treated patients had a statistical trend in improvement of signs (corneal fluorescein staining/CFS) and symptoms (Ocular Surface Disease Index/OSDI, individual patient symptom assessments, and investigator global assessments) compared to the vehicle control treated patients.
- EBI-005 treated subjects used significantly less rescue artificial tears than those subjects receiving vehicle control (p=0.032).
- EBI-005 demonstrated a rapid onset of action with observed improvement in both signs and symptoms as soon as 2 weeks.
- There was no difference in the safety profile of EBI-005 treated subjects vs. the vehicle control treated subjects, and no patient discontinued the study.
- There were no serious adverse events reported.
“These results support the upcoming twelve-week multi-center pivotal study designed to confirm the activity of EBI-005 in patients with dry eye disease and provide encouraging data to investigate EBI-005 for additional ocular surface conditions mediated by IL-1 such as ocular allergy,” commented Michael H. Goldstein, M.D., Head of Medical Research at Eleven Biotherapeutics and co-director of the Cornea, External Disease and Cataract Service group at Tufts University/New England Eye Center. “EBI-005 had a positive effect on signs and symptoms of all moderate to severe DED patients treated in the study. 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.”
The Phase 1b/2a clinical trial was a double-masked, multi-center, randomized, placebo-controlled, environmental study to evaluate two doses of EBI-005 over a six-week period in subjects with moderate to severe dry eye disease. The trial enrolled 74 subjects throughout the United States. The primary objective of the study was to determine the safety and tolerability of EBI-005 at two doses vs. the placebo (vehicle) control. In addition, the study was designed to assess the biologic activity of EBI-005 on the signs and symptoms of dry eye disease as compared to baseline and to the placebo (vehicle) control.
About Dry Eye Disease
Dry eye disease (DED) is an ocular surface inflammatory condition induced by desiccating stress and mediated by an inflammatory cascade regulated by IL-1. DED affects approximately 10 percent of individuals between 30 to 60 years of age, and up to 15 percent of those over 65. Despite its prevalence and impact on quality of life, DED is under-diagnosed, under-treated and has few safe and effective treatment options.
Eleven Biotherapeutics’ lead product candidate, EBI-005, is a novel, interleukin-1 (IL-1) receptor antagonist currently entering pivotal clinical development as a rationally-designed topical protein for the treatment of inflammatory diseases at the surface of the eye. Clinical studies in patients with dry eye disease, conducted by both Eleven and collaborators, have validated the blockade of IL-1 as an efficacious mechanism for treating dry eye disease. Eleven’s first clinical study of EBI-005 in patients with dry eye disease demonstrated that EBI-005 was generally safe, well-tolerated, and showed statistically significant improvements in signs and symptoms of dry eye disease when compared to baseline. EBI-005 has been designed to have optimal physical, pharmaceutical and therapeutic properties, including topical ophthalmic administration, for the treatment of ocular diseases including dry eye and severe ocular allergy.
About Eleven Biotherapeutics
Eleven Biotherapeutics creates novel and differentiated biotherapeutics that are first-of-a-kind protein-based drugs with significantly improved physical and pharmaceutical characteristics designed to provide therapeutic benefits. The company’s AMP-Rx™ product engine brings capabilities beyond conventional approaches for making protein therapeutics, opening up new territory for the products to have novel structures, enhanced biophysical properties, and more effective targeting in disease pathways. Eleven’s success is built on designing proteins ‘fit for purpose’ that are rationally designed to have ideal therapeutic characteristics and result in best-in-class biotherapeutic products for a wide range of diseases. The Cambridge, Mass.-based company was founded in 2010 by life science investors Flagship Ventures and Third Rock Ventures and world-renowned scientific experts. For more information, please visit www.elevenbio.com.
1 Topical Interleukin 1 Receptor Antagonist for Treatment of Dry Eye Disease: A Randomized Clinical Trial. JAMA Ophthalmol. April 18, 2013.