Eleven Biotherapeutics Completes Enrollment in Pivotal Phase 3 Study of EBI-005 in Patients with Dry Eye Disease

CAMBRIDGE, Mass.--()--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.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, advancement or maturation of its product candidates and product pipeline, clinical development of the Company's therapeutic candidates, including expectations regarding timing of initiation of clinical trials, patient enrollment and availability of results, regulatory requirements for initiation of clinical trials and registration of product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from ongoing clinical trials, whether results of early clinical trials will be indicative of the results of future trials, the adequacy of any clinical models, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals and other factors discussed in the "Risk Factors" section of the Company's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 13, 2014 and other reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

Contacts

Eleven Biotherapeutics
Leah Monteiro, 617-714-0619
Leah.Monteiro@elevenbio.com

Release Summary

Eleven Biotherapeutics completed patient enrollment in its first pivotal, Phase 3 clinical study of EBI-005 in patients with dry eye disease.

Contacts

Eleven Biotherapeutics
Leah Monteiro, 617-714-0619
Leah.Monteiro@elevenbio.com