Eleven Biotherapeutics fails to meet primary endpoint in topical allergic conjunctivitis trial

Eleven Biotherapeutics’ lead investigational drug EBI-005 did not meet the primary endpoint of reducing mean ocular itching compared with vehicle control in a modified environmental exposure chamber model, according to a company press release.

Giving top-line data from a phase 2 investigation of the drug candidate in patients with mild to severe allergic conjunctivitis, Eleven Biotherapeutics reported statistically significant improvement in the secondary endpoint of mean change from baseline in patient-reported ocular itching compared to vehicle control in a conjunctival allergen provocation test (CAPT) model.

The phase 2 study included 159 patients who were randomly assigned to one of two repetitive allergen challenge models, the CAPT or the modified environmental exposure chamber (EEC) model.

Patients assigned to the CAPT model demonstrated improvements compared with vehicle control with regard to exploratory endpoints of ocular tearing and nasal symptoms at the second to last and final evaluations.

Statistically significant improvements were observed in lid swelling among patients administered EBI-005 compared with vehicle control at the second to last (P = .011) and final (P = .037) evaluations in the EEC model vs. the CAPT model, according to the press release.