Patient Randomization and Dosing Underway in Allergic Conjunctivitis;
Scientific Advice Received from European Medicines Agency
CAMBRIDGE, Mass.--Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that it received a no-objection letter from Health Canada and that patient dosing is underway in the Company’s Phase 2 clinical trial of EBI-005 for the treatment of allergic conjunctivitis (AC). EBI-005, the Company’s most advanced product candidate generated using its AMP-Rx platform, is a novel, topically administered Interleukin-1 (IL-1) receptor blocker. EBI-005 was designed to bind and block the IL-1 receptor to prevent transmission of biological signals responsible for many of the signs and symptoms of ocular surface diseases.
This Phase 2 trial is expected to include approximately 150 subjects in Canada. Subjects will be randomized to receive EBI-005 or a vehicle-control. The primary endpoint of the study is reduction in subject reported ocular itching. Additional endpoints include reduction in redness, swelling and other signs of ocular allergy. The safety and tolerability of EBI-005 compared to vehicle-control will also be evaluated. Based on estimates of patient enrollment, the Company expects that top line data from this Phase 2 study will be available in the second half of 2014.
In addition to allergic conjunctivitis, EBI-005 is also being evaluated in an ongoing pivotal Phase 3 clinical trial in the United States for the treatment of moderate to severe dry eye disease (DED). The trial is a multi-center, double-masked, randomized, controlled, efficacy and safety study of EBI-005 compared to a vehicle control in subjects with moderate to severe DED. The Company is evaluating the development of EBI-005 in Europe in addition to the U.S. and has sought and received scientific advice from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding European registration requirements for EBI-005 for the treatment of DED. The scientific advice received indicates that the requirements for European registration in DED will differ from the requirements for registration in the U.S. and the Company’s planned pivotal Phase 3 clinical program for the U.S. is not consistent with the advice of the CHMP. As a result, the Company has decided to continue with its original U.S. registration plan to initiate the second pivotal Phase 3 trial in DED after reviewing top-line data from the ongoing U.S. pivotal Phase 3 trial. Based on estimates of patient enrollment, the Company expects that top-line data from the first pivotal Phase 3 trial will be available in early 2015. The Company will continue to evaluate the scientific advice received from the EMA and plans to further discuss with the EMA a registration plan for EBI-005 in DED for the European Union.
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.