Patient Randomization and Dosing Underway
CAMBRIDGE, MA, USA I February 18, 2014 I Eleven Biotherapeutics (EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that patient randomization and dosing are underway in the Company’s first pivotal Phase 3 clinical study of EBI-005 for the treatment of moderate to severe dry eye disease (DED), 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). EBI-005, the Company’s most advanced product candidate generated using its AMP-Rx platform, is a novel, topically administered Interleukin-1 (IL-1) receptor blocker currently in development for the treatment of dry eye disease and allergic conjunctivitis. EBI-005 was 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.
This pivotal Phase 3 trial will include approximately 650 subjects in the U.S. Subjects will be randomized to receive EBI-005 or a vehicle-control. The co-primary endpoints of the study are change in corneal fluorescein staining score (a sign of dry eye disease) and improvement in 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 the Company’s Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. Based on estimates of patient enrollment, the Company expects that top line data from this pivotal Phase 3 study will be available in early 2015.
About EBI-005
Eleven Biotherapeutics’ most advanced product candidate is EBI-005, which was designed, engineered and generated using the Company’s AMP-Rx platform and is being developed as a topical treatment for dry eye disease and allergic conjunctivitis. In 2013, Eleven Biotherapeutics completed a Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine interleukin-1, or IL-1, play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the redness and itching associated with allergic conjunctivitis.
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. The Company’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: 122
Patient Randomization and Dosing Underway
CAMBRIDGE, MA, USA I February 18, 2014 I Eleven Biotherapeutics (EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that patient randomization and dosing are underway in the Company’s first pivotal Phase 3 clinical study of EBI-005 for the treatment of moderate to severe dry eye disease (DED), 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). EBI-005, the Company’s most advanced product candidate generated using its AMP-Rx platform, is a novel, topically administered Interleukin-1 (IL-1) receptor blocker currently in development for the treatment of dry eye disease and allergic conjunctivitis. EBI-005 was 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.
This pivotal Phase 3 trial will include approximately 650 subjects in the U.S. Subjects will be randomized to receive EBI-005 or a vehicle-control. The co-primary endpoints of the study are change in corneal fluorescein staining score (a sign of dry eye disease) and improvement in 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 the Company’s Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. Based on estimates of patient enrollment, the Company expects that top line data from this pivotal Phase 3 study will be available in early 2015.
About EBI-005
Eleven Biotherapeutics’ most advanced product candidate is EBI-005, which was designed, engineered and generated using the Company’s AMP-Rx platform and is being developed as a topical treatment for dry eye disease and allergic conjunctivitis. In 2013, Eleven Biotherapeutics completed a Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine interleukin-1, or IL-1, play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the redness and itching associated with allergic conjunctivitis.
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. The Company’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: 122
