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Eleven Biotherapeutics to Present Data on Ocular Therapeutics Pipeline at the ARVO 2015 Annual Meeting
[April 22, 2015]

Eleven Biotherapeutics to Present Data on Ocular Therapeutics Pipeline at the ARVO 2015 Annual Meeting


Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that one oral presentation and two posters have been selected for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting taking place May 3-7, 2015, in Denver, CO. The presentations include clinical data on Eleven's lead product candidate, EBI-005, which is in late-stage clinical development for dry eye disease and allergic conjunctivitis, as well as preclinical data for its second product candidate, EBI-031, which is in development for diabetic macular edema. Presentation abstracts can be found on the ARVO website at http://www.arvo.org/Annual_Meeting/Program/. Updated and detailed results from these studies will be presented at the conference.

"We are pleased to be presenting such a comprehensive body of work related to Eleven's ocular therapeutics pipeline, including EBI-005 and EBI-031, at the ARVO Annual Meeting," said Abbie Celniker, PhD, President and Chief Executive Officer of Eleven Biotherapeutics. "The breadth of data reflects our continued commitment to Eleven's mission of leveraging our proprietary technology platform to create novel therapeutics to treat ocular diseases, and we are excited to discuss our progress at this important industry event. We are also looking forward to reporting top-line pivotal Phase 3 results for EBI-005 in dry eye disease later in the second quarter of 2015."

Oral Presentation:

  • Comparison of Two Clinical Repeat Allergen Challenge Models to Evaluate EBI-005 in the Late Phase Inflammatory Response in Allergic Conjunctivitis
    Author: Goldstein, Eleven Biotherapeutics
    Presentation #: 5872
    Date/ Time: Thursday, May 7, 2015, 12:45 PM to 1:00 PM PT
    Session #/Title: 531, Allergic conjunctivitis and ocular inflammation
    Location: Room 601/603
    This presentation describes a Phase 2 study in subjects with late phase allergic conjunctivitis in which EBI-005 was evaluated in two different clinical models adapted for the late phase inflammatory response. This is an area of high unmet need and represents the patient population in allergic conjunctivitis for which EBI-005 is being developed.

Poster Presentations:

  • Optimized intravitreal IL-6 antagonist for the treatment of diabetic macular edemaAuthor: Schmidt, Eleven Biotherapeutics


    Poster #: 3488 - D0346
    Date/Time: Tuesday, May 5, 2015 from 11:00 AM to 12:45 PM PT
    Session #/Title: 348, Ocular disease, inflammation, and cytokines
    This poster describes the role of IL-6 blockade in diabetic macular edema and the ability of EBI-031 to potently inhibit IL-6 signaling with extended vitreal retention in preclinical pharmacokinetic studies.
  • Clinical Development of EBI-005, a Novel Interleukin-1 Receptor Inhibitor, for Patients with Ocular Surface Inflammation
    Author: Tubridy, Eleven Biotherapeutics
    Poster #: 4488 - A0114
    Date/Time: Wednesday, May 6, 2015, 11:00 AM to 12:45 PM PT
    Session #/Title: 438, Dry eye disease, II
    This poster presentation describes how data related to dosing, disease severity, patient selection, and endpoint selection from a completed phase 1b/2a study of EBI-005 in patients with moderate to severe dry eye disease shaped the design of the pivotal, Phase 3 study in dry eye disease.

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 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 EBI-031

Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME. EBI-031 has been designed and engineered for intravitreal delivery using our AMP-Rx platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R) and has demonstrated a longer vitreal retention time in preclinical models than antibodies and antibody-like molecules approved for intravitreal injection. We are undertaking the necessary manufacturing development work and nonclinical safety studies to support the submission of an investigational new drug application, or IND, to the FDA by the end of 2015 for the purpose of conducting clinical trials of EBI-031 in DME.

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, sufficiency of cash resources 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2015 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.


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