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Eleven Biotherapeutics completes patient enrollment for phase 3 study of isunakinra
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Eleven Biotherapeutics has completed patient enrollment for the pivotal phase 3 study of isunakinra in patients with allergic conjunctivitis, the company announced in a press release.
Isunakinra (EBI-005) is a topical interleukin-1 receptor blocker under study for use in moderate to severe allergic conjunctivitis. A total of 258 patients were randomized 1:1 to receive treatment with isunakinra or vehicle control in the multicenter, double-masked study. Safety and efficacy will be evaluated for up to 4½ weeks.
“The completion of patient enrollment for this study of moderate to severe allergic conjunctivitis keeps us on target for a first quarter 2016 announcement of top line results,” Abbie Celniker, PhD, president and CEO of Eleven Biotherapeutics, said in the release. “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.”
The company plans to initiate a second phase 3 trial in the second half of 2016 if the results from the first phase 3 trial are favorable, the release said.