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Eleven Biotherapeutics to Present Data at the ARVO 2016 Annual Meeting

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that one oral presentation and three posters have been selected for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting taking place May 1-5, 2016, in Seattle, WA. The presentations include preclinical data for EBI-031, which is in development for diabetic macular edema and Phase 3 clinical data on isunakinra (EBI-005). Presentation abstracts can be found on the ARVO website at https://www.arvo.org/AM/Program/.

"We are pleased to be presenting important preclinical data on EBI-031, an IL-6 antagonist, at the ARVO Annual Meeting demonstrating characteristics that include extended therapeutic duration and rapid systemic clearance," said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. "These data support our planned submission of an investigational new drug application this quarter for the purpose of conducting clinical trials in diabetic macular edema and uveitis. In addition, we will be presenting the Phase 3 data for isunakinra in allergic conjunctivitis and dry eye disease, including post hoc evaluation of patient IL-1 genotypes and the differential clinical response to IL-1 blockade."

Oral Presentation:

  • Optimized Intravitreal IL-6 Antagonist for the Treatment of Diabetic Macular Edema and Uveitis
    Author: Eric Furfine, Ph.D., Eleven Biotherapeutics
    Presentation #: 6017
    Date/Time: Thursday, May 5, 2016 from 11:15 AM to 11:30 PM PT
    Session #/Title: 525, Diabetic retinopathy
    Location: Room 615/617
    This presentation will discuss the findings from a non-human primate study, including half-life, immune response and potency.

Poster Presentations:

  • Phase 3 Multi-Center Trial Evaluating the Efficacy, Safety and Tolerability of Isunakinra in Subjects with Moderate to Severe Allergic Conjunctivitis
    Author: Michael Goldstein, M.D., M.B.A., Eleven Biotherapeutics
    Poster #: 2307 – C0121
    Date/Time: Sunday, May 1, 2016 from 8:30 AM to 10:15 AM PT
    Session #/Title: 113, Allergic conjunctivitis / Corneal Immunology and Infection
    This poster describes the results of an environmental study of isunakinra compared to vehicle control given over 4 weeks in patients with moderate to severe allergic conjunctivitis.
  • A Multi-Center Phase 3 Safety and Tolerability Study of Isunakinra in Subjects with Moderate to Severe Dry Eye Disease
    Author: Leontia Burke, Eleven Biotherapeutics
    Poster #: 2872 - A0081
    Date/Time: Tuesday, May 3, 2016 from 8:30 AM to 10:15 AM PT
    Session #/Title: 310, Dry Eye II
    This poster presents the safety profile of isunakinra given for up to 6 months in patients with moderate to severe dry eye disease.
  • A Phase 3 Multi-Center, Randomized Controlled Evaluation of the Efficacy, Safety and Tolerability of Isunakinra in Subjects with Moderate to Severe Dry Eye Disease
    Author: Karen Tubridy, Pharm.D., Eleven Biotherapeutics
    Poster #: 2874 - A0083
    Date/Time: Tuesday, May 3, 2016 from 8:30 AM to 10:15 AM PT
    Session #/Title: 310, Dry Eye II
    The poster presentation describes the results of the efficacy trial of isunakinra compared to vehicle-control given over 12 weeks in moderate to severe dry eye disease.

About EBI-031

Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed and engineered for intravitreal delivery using Eleven's 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. Eleven is 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 in the first half of 2016 for the purpose of conducting clinical trials of EBI-031 in DME and uveitis.

About Eleven Biotherapeutics

Eleven Biotherapeutics, Inc. is a preclinical-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. For more information please refer to the Company's website www.elevenbio.com.

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 product candidates, including expectations regarding timing of regulatory submissions and initiation of clinical trials, regulatory requirements for initiation of clinical trials and registration of product candidates, the review of its strategic alternatives and the outcome of such review, the sufficiency of its 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 clinical trials, whether results of early clinical trials or preclinical studies 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 report on Form 10-K for the year ended December 31, 2015 as filed with the Securities and Exchange Commission 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.

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

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