CAMBRIDGE, MA, USA I November 3, 2014 I Eleven Biotherapeutics (NASDAQ:EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the completion of patient enrollment in its first pivotal, Phase 3 clinical study of EBI-005 in patients with dry eye disease. EBI-005, a topical, novel interleukin-1 (IL-1) receptor blocker, is Eleven’s lead drug candidate in development for the treatment of moderate to severe dry eye disease and allergic conjunctivitis.
“The completion of patient enrollment in this study in dry eye disease is another key milestone in our development of EBI-005,” said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. “Over half of the subjects have completed the study, and we look forward to reporting top-line results in the second quarter of 2015.”
The OASIS study (A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control In Subjects With Moderate to Severe Dry Eye Disease) is being conducted at 45 study centers across the United States. In this study, 650 patients with moderate to severe dry eye disease have been enrolled and randomized for treatment with either EBI-005 or vehicle-control for a period of 12 weeks followed by a three week safety assessment. The co-primary endpoints of the study are change in total corneal fluorescein staining score (a sign of dry eye disease) and improvement in ocular pain and discomfort (a symptom of dry eye disease). The safety and tolerability of EBI-005 compared to vehicle-control will also be evaluated. This pivotal Phase 3 trial was designed based on the results observed in Eleven’s Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease.
About Dry Eye Disease
Dry eye disease (DED) is a potentially debilitating disease of the eye that may, in its most severe forms, have sight-threatening corneal complications. DED is one of the leading causes of patient visits to eye care professionals in the United States. According to Market Scope, approximately 68 million people in the United States, European Union, Japan and other developed markets have DED, including approximately 26 million who suffer from the moderate to severe form of DED. Approximately 19 million people in the United States have DED, including approximately seven million people who suffer from the moderate to severe form of DED. We believe that DED, a chronic ocular surface inflammatory condition, is initiated and maintained by an inflammatory process where IL-1 is a key player. We believe that stress on the ocular surface leads to excess production of IL-1 resulting in increased ocular surface inflammation and hypersensitization of peripheral corneal nerves.
About EBI-005
Eleven Biotherapeutics’ most advanced product candidate is EBI-005, a novel, topically-administered IL-1 receptor blocker in development as a protein therapeutic for dry eye disease and allergic conjunctivitis. 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 and pain associated with dry eye disease and the itching and other symptoms associated with allergic conjunctivitis. EBI-005 has been evaluated in a Phase 2 study in patients with moderate to severe allergic conjunctivitis and is currently being evaluated in a pivotal Phase 3 study in dry eye disease.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven’s therapeutic approach is based on the role of cytokines in diseases of the eye, the company’s understanding of the structural biology of cytokines and the company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects.
SOURCE: Eleven Biotherapeutics
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CAMBRIDGE, MA, USA I November 3, 2014 I Eleven Biotherapeutics (NASDAQ:EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the completion of patient enrollment in its first pivotal, Phase 3 clinical study of EBI-005 in patients with dry eye disease. EBI-005, a topical, novel interleukin-1 (IL-1) receptor blocker, is Eleven’s lead drug candidate in development for the treatment of moderate to severe dry eye disease and allergic conjunctivitis.
“The completion of patient enrollment in this study in dry eye disease is another key milestone in our development of EBI-005,” said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. “Over half of the subjects have completed the study, and we look forward to reporting top-line results in the second quarter of 2015.”
The OASIS study (A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control In Subjects With Moderate to Severe Dry Eye Disease) is being conducted at 45 study centers across the United States. In this study, 650 patients with moderate to severe dry eye disease have been enrolled and randomized for treatment with either EBI-005 or vehicle-control for a period of 12 weeks followed by a three week safety assessment. The co-primary endpoints of the study are change in total corneal fluorescein staining score (a sign of dry eye disease) and improvement in ocular pain and discomfort (a symptom of dry eye disease). The safety and tolerability of EBI-005 compared to vehicle-control will also be evaluated. This pivotal Phase 3 trial was designed based on the results observed in Eleven’s Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease.
About Dry Eye Disease
Dry eye disease (DED) is a potentially debilitating disease of the eye that may, in its most severe forms, have sight-threatening corneal complications. DED is one of the leading causes of patient visits to eye care professionals in the United States. According to Market Scope, approximately 68 million people in the United States, European Union, Japan and other developed markets have DED, including approximately 26 million who suffer from the moderate to severe form of DED. Approximately 19 million people in the United States have DED, including approximately seven million people who suffer from the moderate to severe form of DED. We believe that DED, a chronic ocular surface inflammatory condition, is initiated and maintained by an inflammatory process where IL-1 is a key player. We believe that stress on the ocular surface leads to excess production of IL-1 resulting in increased ocular surface inflammation and hypersensitization of peripheral corneal nerves.
About EBI-005
Eleven Biotherapeutics’ most advanced product candidate is EBI-005, a novel, topically-administered IL-1 receptor blocker in development as a protein therapeutic for dry eye disease and allergic conjunctivitis. 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 and pain associated with dry eye disease and the itching and other symptoms associated with allergic conjunctivitis. EBI-005 has been evaluated in a Phase 2 study in patients with moderate to severe allergic conjunctivitis and is currently being evaluated in a pivotal Phase 3 study in dry eye disease.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven’s therapeutic approach is based on the role of cytokines in diseases of the eye, the company’s understanding of the structural biology of cytokines and the company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects.
SOURCE: Eleven Biotherapeutics
Post Views: 255
