Eleven Biotherapeutics Publishes Clinical Data on EBI-005 for the Treatment of Allergic Conjunctivitis

Phase 2 Results Published in Eye and Contact Lens Demonstrate Statistically Significant and Clinically Meaningful Improvements with EBI-005 and Support Planned Phase 3 Clinical Study Design

CAMBRIDGE, Mass.--()--Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the publication of clinical data in the May 2015 issue of Eye and Contact Lens on EBI-005, its novel, protein therapeutic which is in late-stage clinical development for dry eye disease and allergic conjunctivitis. In the paper, entitled “A Phase 2 Exploratory Study of a Novel Interleukin-1 Receptor Inhibitor (EBI-005) in the Treatment of Moderate-to-Severe Allergic Conjunctivitis,” Michael H. Goldstein, MD, Chief Medical Officer of Eleven Biotherapeutics, describes Phase 2 clinical data for Eleven’s lead drug candidate, EBI-005, the first IL-1 (Interleukin-1) receptor inhibitor designed for topical ocular administration. These data demonstrate statistically significant improvements with EBI-005 in ocular itching, ocular tearing and associated nasal symptoms and confirm the clinical benefit of EBI-005 in the late phase inflammatory response. Based on these results, the company plans to initiate a Phase 3 clinical study in the second half of 2015 in patients with moderate to severe allergic conjunctivitis.

“Based on these data, which demonstrate clinically meaningful, statistically significant improvement in patient symptoms, we are well positioned to initiate our Phase 3 clinical study in subjects with moderate to severe allergic conjunctivitis.”

“The publication of these data confirm the effect that EBI-005 has on the late phase allergic response in moderate to severe allergic conjunctivitis and demonstrate that EBI-005 was well tolerated in this population,” said Abbie Celniker, PhD, Chief Executive Officer of Eleven Biotherapeutics. “We believe we have a clear understanding of an ideal trial design to evaluate the late-stage allergic response and are looking forward to initiating a Phase 3 clinical study of EBI-005 in patients with moderate to severe allergic conjunctivitis in the second half of 2015.”

“There is a substantial unmet medical need to treat the late phase allergic response seen in patients with moderate to severe allergic conjunctivitis,” said Dr. Goldstein. “Based on these data, which demonstrate clinically meaningful, statistically significant improvement in patient symptoms, we are well positioned to initiate our Phase 3 clinical study in subjects with moderate to severe allergic conjunctivitis.”

Highlights of the paper include:

  • 159 subjects with moderate to severe allergic conjunctivitis were randomized to topical EBI-005 (5 mg/mL) or vehicle control given 3 times per day and repeatedly challenged with allergen using an adaptation of two clinical models of AC: repetitive challenges in an allergy chamber or repetitive challenges with a modified direct conjunctival allergen challenge.
  • In the modified direct conjunctival allergen challenge model, EBI-005–treated subjects showed clinically meaningful, statistically significant improvements in ocular itching compared with vehicle control at the final 2 efficacy time points, visit 6 (p=0.033) and visit 7 (p=0.046). In the allergy chamber model, the prespecified primary endpoint of ocular itching was not met.
  • EBI-005–treated subjects utilizing the modified direct conjunctival allergen challenge model also showed statistically significant improvement compared with vehicle control in ocular tearing (p=0.027 and p=0.044) and nasal symptoms (P=0.004 and P=0.011) at visit 6 and visit 7.
  • EBI-005 was well tolerated with no treatment related serious adverse events.
  • These results support the next planned study in moderate to severe allergic conjunctivitis subjects in an environmental setting to assess efficacy and safety of EBI-005 on the late phase allergic response.

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 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.

Contacts

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

Website

Release Summary

Phase 2 Results Published in Eye and Contact Lens Demonstrate Statistically Significant and Clinically Meaningful Improvements with EBI-005 and Support Planned Phase 3 Clinical Study Design

Eleven Biotherapeutics, Inc.