Eleven Biotherapeutics has completed patient enrolment in its first pivotal, Phase III clinical study of isunakinra (EBI-005) in patients with moderate to severe allergic conjunctivitis. Isunakinra, a topical, novel interleukin-1 (IL-1) receptor blocker, is Eleven’s lead drug candidate in development for the treatment of moderate to severe allergic conjunctivitis.
Eleven Biotherapeutics completes enrolment in pivotal Phase III study of isunakinra (EBI-005) in patients with allergic conjunctivitis
“The completion of patient enrolment in this study of moderate to severe allergic conjunctivitis keeps us on target for a first quarter 2016 announcement of top-line results,” said Abbie Celniker, President and CEO of Eleven Biotherapeutics. “Isunakinra is a drug candidate with potential to treat patients who are not well addressed with standard of care therapies for ocular allergy including forms of allergic conjunctivitis that can be chronic and in some cases sight threatening.”
This multicenter, double-masked, randomized, vehicle controlled Phase III pivotal trial is designed to evaluate the safety and efficacy of isunakinra for up to four and one half weeks in patients with moderate to severe allergic conjunctivitis in an environmental setting. A total of 258 patients were randomized 1:1 to receive treatment with isunakinra or with vehicle-control. If the results of this first Phase III trial are favourable, Eleven intends to initiate a second Phase III trial in the second half of 2016.
This Phase III study was designed and initiated following the completion of a Phase II study in October 2014, in which isunakinra exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis who were not well treated with standard of care therapy. This included statistically significant improvements in mean change from baseline in patient reported ocular itching, tearing and associated nasal symptoms compared to vehicle-control at the second to last and final assessment time points following allergen exposure in a modified, repeat direct conjunctival allergen provocation test (CAPT) model.
