Eleven Biotherapeutics Presents Data on EBI-005, a Novel IL-1 Inhibitor Protein for Topical Treatment of Dry Eye Disease

Eleven Biotherapeutics Presents Data on EBI-005, a Novel IL-1 Inhibitor Protein for Topical Treatment of Dry Eye Disease 

-- First rationally-designed, topically administered IL-1 protein for clinical development in ocular inflammatory disorders
-- Data presented at ARVO 2012 Annual Meeting demonstrate beneficial effects of targeting and blocking IL-1 for ocular inflammation

Cambridge, MA, May 7, 2012 – Eleven Biotherapeutics, a biopharmaceutical company designing and engineering novel and differentiated protein-based biotherapeutics, announced today the presentation of data for EBI-005, the lead drug candidate from Eleven's AMP-Rx product engine, at the Association for Research in Vision and Ophthalmology (ARVO) 2012 Annual Meeting.  Eleven Biotherapeutics researchers presented preclinical data demonstrating optimal properties of EBI-005 for the treatment of dry eye disease (DED), such as high potency, thermal stability and very low systemic exposure.  EBI-005, is the first ever rationally-designed, IL-1 (Interleukin-1) receptor inhibitor protein for topical administration that is optimized for the treatment of DED and other ocular surface inflammatory disorders.

"Targeting IL-1 is one of the most promising therapeutic approaches for treating dry eye disease because IL-1 is a critical mediator of the inflammatory cascade that causes both the surface disease and symptoms suffered by patients with dry eye disease," said Reza Dana, MD, Director, Cornea and Refractive Surgery Service, Massachusetts Eye and Ear Infirmary, and Professor and Senior Scientist, Harvard Medical School Department of Ophthalmology.  "To date, blocking of IL-1 has only taken the conventional form of proteins as injectable therapies. EBI-005 is unique in that it is rationally designed to be a topically-administered protein that blocks IL-1alpha and IL-1beta and has other ideal pharmacologic and pharmaceutical properties."

"The early activity observed with EBI-005 in dry eye disease animal models and its great pharmaceutical properties are very encouraging," said Abbie Celniker, PhD, Chief Executive Officer of Eleven Biotherapeutics.  "We look forward to further evaluating the potential of EBI-005, a more potent and optimal topical IL-1 receptor blocker in clinical studies that we will initiate in the second half of 2012, as there is a critical need for more effective, topically administered treatment options for patients with dry eye disease."

In a poster presentation entitled "EBI-005 an Interleukin-1 Receptor Inhibitor Designed for the Treatment of Dry Eye Syndrome," Eleven Biotherapeutics researchers presented preclinical and clinical data establishing that:

• DED is an ocular surface inflammatory condition induced by desiccating stress and mediated by IL-1 initiation and maintenance of the Th17 pathway.
• IL-1 receptor antagonism attenuates the signs and symptoms of DED in a Phase 2 study.
• EBI-005 is an IL-1 receptor blocker rationally-designed and optimized for topical ocular administration.
• EBI-005 binds IL-1R1 approximately 10-fold more potently than anakinra which may optimize EBI-005's frequency of administration as a result of long receptor occupancy time.
• EBI-005 is more active than topical cyclopsporin (the active ingredient of Restasis™) at reducing disease.
•  The high thermal stability of EBI-005 creates the potential for an ambient temperature-stable product.
•  EBI-005 distributes well to ocular surface tissues and has low systemic exposure to reduce the risk of immune suppression related adverse events associated with systemic IL-1 antagonism.

About Dry Eye Disease
Dry eye disease (DED) is an ocular surface inflammatory condition induced by desiccating stress and mediated by an inflammatory cascade regulated by IL-1. DED affects approximately 10% of individuals between 30 to 60 years of age, and up to 15% of those over 65. Despite its prevalence and impact on quality of life, DED is under-diagnosed, under-treated and has few safe and effective treatment options.

About EBI-005
Eleven Biotherapeutics lead product candidate, EBI-005, is a novel interleukin-1 receptor antagonist  poised to enter clinical development in 2012 as the first protein therapeutic specifically designed for topical delivery to the eye for the treatment of surface of the eye disease. EBI-005 has been designed to have superior physical, pharmaceutical and therapeutic properties including topical ophthalmic administration for the treatment of ocular diseases including dry eye and severe ocular allergy. The mechanism of action for EBI-005 has been validated in clinical proof-of-concept studies in which IL-1 blockage was shown to be safe and well-tolerated without burning or irritation.

About Eleven Biotherapeutics
Eleven Biotherapeutics creates novel and differentiated biotherapeutics: first-of-a-kind protein-based drugs with significantly improved physical, pharmaceutical, and therapeutic benefits. The company's AMP-Rx™ product engine brings capabilities beyond conventional approaches for making protein therapeutics, opening up new territory for the products to have novel structures, enhanced biophysical properties, and more effective targeting in disease pathways. Eleven's success is built on designing proteins 'fit for purpose' that are rationally designed to have ideal therapeutic characteristics and result in best-in-class biotherapeutic products for a wide range of diseases. The Cambridge, Mass.-based company was founded in 2010 by life science investors Flagship Ventures and Third Rock Ventures and world-renowned scientific experts. For more information, please visit www.elevenbio.com.

Restasis™ is a registered trademark of Allergan, Inc.

Eleven Biotherapeutics
Cameron Wheeler, PhD
[email protected]

Gina Nugent
The Yates Network
[email protected]