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Phase III trial of EBI 005 (isunakinra) for allergic conjunctivitis fails to meet endpoint- Eleven Biotherapeutics

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Last updated:17th Jan 2016
Published:17th Jan 2016
Source: Pharmawand

Eleven Biotherapeutics has announced top-line results from the Phase III clinical trial of its lead drug candidate EBI 005 (isunakinra) for the treatment of severe allergic conjunctivitis. In this trial, there were no statistically significant differences between the isunakinra treated group and the vehicle control group on the primary endpoint of ocular itching or on any secondary endpoints. Isunakinra was generally well tolerated, with 94% of the patients completing the trial and there were no serious adverse events reported.

The multi-center, double-masked, randomized, vehicle controlled Phase III clinical trial was designed to evaluate the safety and efficacy of isunakinra for up to four 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.

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