Eleven Biotherapeutics uses its proprietary technology platform to create first-of-a-kind protein therapeutics to address unmet needs for ophthalmic diseases.
EBI-005: A novel IL-1 receptor antagonist and the first protein specifically designed for topical delivery to the eye for the treatment of ocular surface disease Dry Eye/Allergic Conjunctivitis
Proteins are able to modulate inflammatory cytokines, key targets in ocular disease that have been difficult to access with conventional therapeutic approaches. A significant untapped opportunity exists for protein therapeutics to address ophthalmic diseases, and Eleven is applying its advanced protein technology and expertise to develop innovative medicines for patients suffering from ocular diseases. Eleven’s team of industry veterans has deep experience in understanding protein science and biologic drug development, designing and conducting clinical trials and, most importantly, applying specific expertise in ophthalmic disease to create novel ocular therapeutics to treat unmet medical needs.
Eleven has developed a proprietary pipeline of ophthalmic drug candidates derived from the company’s innovative AMP-Rx protein engineering technology. The company’s initial product candidates are focused on targeting inflammatory cytokines and key targets of ocular disease by blocking the cytokines and modulating the biological processes that drive ocular disease. Current pipeline opportunities include ocular surface diseases such as dry eye disease (DED) and allergic conjunctivitis (AC), and back of the eye diseases such as diabetic macular edema (DME) and uveitis. In addition, Eleven’s proprietary technology has been utilized to prolong the intravitreal half-life of our pipeline products. Beyond its internal drug development programs, Eleven works with collaborators, such as ThromboGenics, to apply its innovative protein therapeutic design capabilities to engineer and develop biotherapeutic products for additional therapeutic targets.
Dry Eye Treatment
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 often classified as mild, moderate or severe based on clinical symptom severity. 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 people who suffer from the moderate to severe form of the disease. According to Market Scope, approximately 19 million people in the United States have DED, including approximately seven million people who suffer from the moderate to severe form.
Significant unmet need still exists in DED, where many of the estimated seven million moderate to severe DED patients in the United States are not adequately treated with standard-of-care therapies. Due to this inadequate treatment, some moderate to severe DED patients are treated with off-label steroid-based therapies that have been associated with serious side effects.
In 2013, Eleven completed a Phase 1b/2a double-masked, vehicle controlled, clinical trial of EBI-005 in 74 patients with DED. EBI-005 was shown to have clinically relevant effects on signs of DED, with a 39% change from baseline as measured by corneal fluorescein staining (CFS), and on symptoms of DED, such as ocular pain and discomfort with a 61% change from baseline as measured by the ocular surface disease index (OSDI).
Allergic conjunctivitis (AC) is an inflammatory disease of the conjunctiva, the membrane covering the inside of the eyelids and sclera, the white part of the eye, primarily from a reaction to allergy-causing substances, or allergens, such as pollen or pet dander.
Allergic conjunctivitis ranges in clinical severity from relatively mild, common forms to more severe forms that can cause impaired vision and, in the most severe cases, blindness. Of the approximately 11 million patients seeking treatment for allergic conjunctivitis in the United States, we estimate that approximately 4 million have moderate allergic conjunctivitis and approximately 1.8 million have severe allergic conjunctivitis. This severe allergic conjunctivitis is primarily experienced as the late, inflammatory phase, and is often not adequately treated with anti-histamines or mast cell stabilizers. Patients experiencing the late phase may require treatment with steroids, which are known to be associated with sight threatening side effects such as increases in intra-ocular pressure, which can lead to glaucoma.
In October 2014, Eleven reported top-line results from our proof of concept Phase 2 clinical trial of EBI-005 in patients with moderate to severe allergic conjunctivitis. In a modified CAPT (conjunctival allergen provocation test) model, patients treated with EBI-005 showed statistically significant improvements in mean change from baseline in patient reported ocular itching, ocular tearing and total nasal symptoms compared to vehicle-control at the second to last and final assessment time points.