- Study Did Not Achieve Primary Endpoints; No Statistical Difference between EBI-005 and Vehicle Control -
- EBI-005 Program to Focus on Allergic Conjunctivitis with Pivotal Phase 3 Study to Initiate in Second Half of 2015 -
- Conference Call Scheduled for
There was no statistically significant difference between the EBI-005 treated group and the vehicle control group on the co-primary endpoints or any secondary endpoints. Patients with dry eye disease in both the EBI-005 and vehicle treatment groups showed statistically significant improvement from baseline on the co-primary endpoints. While the change from baseline on the co-primary endpoints was greater in the vehicle group than the EBI-005 group, the differences between the two groups were not statistically significant and the company believes the differences were not clinically meaningful. EBI-005 was generally well tolerated in the Phase 3 study with fewer than 5% of patients reporting eye irritation and no treatment related serious adverse events. Approximately 13% of patients in the study reported some use of artificial tears, with no difference in artificial tear use between the EBI-005 treated and vehicle control groups. Overall, 92% of patients completed the study, with 33 patients having dropped out of the EBI-005 group and 20 patients having dropped out of the vehicle control group.
"We are disappointed that our Phase 3 study in dry eye disease did not
meet its primary efficacy endpoints, but we are encouraged that we
continue to see a favorable tolerability profile for EBI-005. Our key
focus will be on continuing to develop EBI-005 to meet unmet medical
needs in allergic conjunctivitis, based on our previously-reported Phase
2 data and scientific rationale supporting EBI-005 as a treatment for
allergic conjunctivitis," said
Eleven continues to prepare to advance EBI-005 into late-stage clinical
development for allergic conjunctivitis, with plans to initiate a
pivotal Phase 3 study in patients with moderate to severe allergic
conjunctivitis in the second half of 2015. Allergic conjunctivitis is a
mechanistically different ocular disease from dry eye disease. The
ocular surface inflammation associated with allergic conjunctivitis is
initiated by a single, central mechanism of allergen stimulation, while
the underlying causes of ocular surface inflammation in dry eye disease
are diverse. In
Eleven has approximately
About the Phase 3 OASIS Study of EBI-005 in Dry Eye Disease
The pivotal Phase 3 OASIS study (a Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control In Subjects With Moderate to Severe Dry Eye Disease), was designed to evaluate the safety and efficacy of EBI-005. The study evaluated 669 patients with moderate to severe dry eye disease. The co-primary endpoints were evaluation of mean change from baseline at week 12 with EBI-005 treatment compared to vehicle control on the total corneal fluorescein staining score and on the patient-reported measurement related to ocular pain and discomfort based on the ocular surface disease index (OSDI), a questionnaire used to measure the symptoms of dry eye disease.
Conference Call Information
Eleven Biotherapeutics' management team will host a conference call and
audio webcast today,
An audio webcast of the call will also be available on the Investors & Media section of the Company's website www.elevenbio.com. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.
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 inflammatory diseases at the surface of the eye. 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, pain, redness, itching and other symptoms associated with ocular surface diseases.
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