Eleven Biotherapeutics
May 6, 2014
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Eleven Biotherapeutics Presents Data on Novel Protein Therapeutics for Treatment of Front and Back of Eye Diseases at ARVO 2014 Annual Meeting

Clinical Data on EBI-005 Demonstrated Improvements in Signs and Symptoms in Patients with Dry Eye Disease through IL-1 Inhibition

Preclinical Data on EBI-029 Demonstrated Inhibition of IL-6 as a Validated Target for Treating Diabetic Macular Edema

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the presentation of data for two of its novel, protein therapeutics demonstrating the key role of cytokine biology to target both front and back of eye diseases at the Association for Research in Vision and Ophthalmology (ARVO) 2014 Annual Meeting in Orlando, FL. Clinical data on Eleven's lead drug candidate, EBI-005, the first IL-1 (Interleukin-1) signaling inhibitor designed for topical ocular administration, demonstrated improvements in signs and symptoms of dry eye disease (DED), including reduction in ocular pain and artificial tear use. In addition, preclinical data on EBI-029, an IL-6 (Interleukin-6) inhibitor optimized for localized ocular administration in diabetic macular edema (DME), has demonstrated that EBI-029 potently inhibits IL-6 signaling in vitro. IL-6 is a cytokine that has previously been shown to be upregulated in DME, contributing to the angiogenic and inflammatory components of the disease and correlating with disease severity. By inhibiting IL-6, EBI-029 could offer an alternative to current standard of care, including anti-VEGF therapies.

"Proteins designed specifically as ophthalmic therapies represents an innovative approach to treating diseases of the eye with high unmet need," said Abbie Celniker, PhD, Chief Executive Officer of Eleven Biotherapeutics. "These data demonstrate Eleven's ability to target both front and back of eye disease by leveraging our extensive cytokine biology expertise."

Dr. Celniker continued, "The data we are presenting on our lead product candidate, EBI-005, underscores its potential utility in treating dry eye disease by inhibiting the cytokine IL-1, a key mediator of inflammation in the eye. Likewise, a correlation has been previously observed between increased IL-6 levels and disease severity in diabetic macular edema, including scenarios where VEGF inhibition treatment has been suboptimal. These data suggest the potential of IL-6 blockade with EBI-029 in treating diabetic macular edema and support further development of EBI-029 either as a stand-alone drug or in combination with VEGF blockade."

EBI-005, a topical IL-1 receptor antagonist for the treatment of ocular surface disease, is currently being evaluated in a pivotal Phase 3 clinical study in subjects with DED and a Phase 2 clinical study in subjects with allergic conjunctivitis. EBI-029, an IL-6 receptor antagonist for localized intravitreal treatment of back of eye disease, is currently in preclinical development for the treatment of DME.

In a poster presentation entitled "Optimized IL-6 Blockade for the Treatment of Diabetic Macular Edema," Eleven Biotherapeutics researchers presented preclinical data which demonstrated that local IL-6 inhibition potently inhibits IL-6 signaling.

In a poster presentation entitled "Topical Interleukin-1 (IL-1) Receptor Inhibition Reduces Ocular Pain" Eleven Biotherapeutics researchers presented clinical data which demonstrated that inhibition of IL-1 reduced frequency of painful or sore eyes suggesting that inhibiting IL-1 signaling in the eye with EBI-005 may directly affect ocular pain associated with DED.

In a poster presentation entitled "Reduced Rescue Artificial Tear Use in Subjects Using a Topical Interleukin-1 (IL-1) Receptor-1 (R1) Blocker for Ocular Treatment of Dry Eye Disease (DED)" Eleven Biotherapeutics researchers presented data from a Phase 1/2b study which demonstrated that EBI-005 treated subjects used fewer rescue artificial tears than vehicle-control treated subjects.

About EBI-005

Eleven Biotherapeutics' most advanced product candidate is EBI-005, which was designed, engineered and generated using the Company's AMP-Rx platform and is being developed as a topical treatment for dry eye disease and allergic conjunctivitis. In 2013, Eleven Biotherapeutics completed a Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine interleukin-1, or IL-1, play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the redness and itching associated with allergic conjunctivitis. EBI-005 is currently being evaluated in a pivotal Phase 3 clinical study in subjects with dry eye disease and a Phase 2 clinical study in subjects with allergic conjunctivitis.

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. The Company'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, 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, 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 prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) on February 6, 2014. 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
Cameron Wheeler, PhD, 617-858-0927
The Yates Network
Gina Nugent, 617-460-3579

Source: Eleven Biotherapeutics

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