Roche (OTCQX:RHHBY) unit Genentech announces topline results from its Phase III study program evaluating etrolizumab in people with moderately to severely active ulcerative colitis.
Mixed results were seen in studies evaluating etrolizumab as an induction therapy and as a maintenance therapy.
In the HIBISCUS I induction study, in people without prior anti-tumor necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint of inducing remission versus placebo and adalimumab.
In contrast, the HIBISCUS II induction study did not meet its primary endpoint.
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.
Further analyses of the data, including secondary endpoints, are ongoing and will be presented at upcoming meetings.
Pivotal Phase III study of etrolizumab in Crohn’s disease is ongoing. Genentech is studying additional investigational medicines in inflammatory bowel diseases (IBD).
Etrolizumab is the first investigational dual anti-integrin studied in IBD.
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