Eleven Biotherapeutics Presents Phase 2 Clinical Data on EBI-005 for the Treatment of Allergic Conjunctivitis at ASCRS 2015 Annual Meeting

Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, will present clinical data for EBI-005, its novel, protein therapeutic which is in late-stage clinical development for dry eye disease and allergic conjunctivitis, at the American Society of Cataract and Refractive Surgery (ASCRS) 2015 Annual Meeting in San Diego, CA. Clinical data on Eleven’s lead drug candidate, EBI-005, the first IL-1 (Interleukin-1) receptor inhibitor designed for topical ocular administration, demonstrated statistically significant improvements in ocular itching, ocular tearing and nasal symptoms associated with the late phase allergen response in patients with allergic conjunctivitis, utilizing a modified direct conjunctival allergen model.

“These data demonstrate the potential utility of EBI-005 in treating more severe forms of allergic conjunctivitis by inhibiting the cytokine IL-1, a key target of ocular surface inflammation,” said Abbie Celniker, PhD, Chief Executive Officer of Eleven Biotherapeutics. “Patients with acute or early-stage allergic conjunctivitis are generally well-maintained with current therapies such as antihistamines and mast-cell stabilizers but a majority of allergic conjunctivitis patients experience late-phase allergic conjunctivitis which current therapies can be unsuccessful in treating. With statistically significant improvements in ocular itching, ocular tearing and nasal symptoms, we believe EBI-005 is well positioned to address the approximately 5.8 million allergic conjunctivitis patients whose needs are not adequately met with current therapies, by inhibiting the underlying inflammation driving the late-phase response. Based on these data, we look forward to initiating a Phase 3 clinical study of EBI-005 in allergic conjunctivitis in the second half of 2015.”

In an oral presentation entitled, “Novel Therapy for Allergic Conjunctivitis Patients Using EBI-005, a Topical Interleukin-1 Receptor Inhibitor”, to be presented on Saturday, April 18, 2015 at 2:01 p.m. PT, Michael H. Goldstein, MD, Eleven’s Chief Medical Officer, describes the Phase 2 clinical data demonstrating statistically significant improvements in ocular itching, ocular tearing and total nasal symptoms in patients selected due to their more severe ocular allergies, utilizing a modified direct conjunctival allergen model.

• Statistically significant improvements in ocular itching (mean change from baseline) compared with vehicle were demonstrated at the final two efficacy time points (p = 0.033 at visit 6 and p = 0.046 at visit 7).
• Statistically significant improvements in ocular tearing (mean change from baseline) compared with vehicle were demonstrated at the final two efficacy time points (p = 0.027 at visit 6 and p = 0.044 at visit 7).
• Statistically significant improvements in total nasal symptoms (mean change from baseline) compared with vehicle were demonstrated at the final two efficacy time points (p = 0.004 at visit 6 and p = 0.011 at visit 7).
• EBI-005 was well tolerated with no treatment related serious adverse events and no evidence of drug specific antibodies.

About EBI-005

Eleven Biotherapeutics’ most advanced product candidate is EBI-005, a novel, topically-administered interleukin-1 (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 plays 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 pivotal Phase 3 studies 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.

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