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Genentech Announces Mixed Results In Phase III Studies Of Etrolizumab On Ulcerative Colitis

Genentech, in its update on phase III studies of Etrolizumab in people with moderately to severely active ulcerative colitis, said that mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo.

In the HIBISCUS I induction study, in people without prior anti-tumor necrosis factor or anti-TNF treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint, Genentech said.

In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint.

The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four Phase III clinical trials reported to date.

Etrolizumab continues to be studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn's disease with and without prior anti-TNF treatment in a global Phase III study and open-label extension and safety monitoring study.

In addition, Genentech is studying other investigational medicines in inflammatory bowel diseases and is committed to further understanding this disease.

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