Roche’s investigational medicine etrolizumab has demonstrated mixed results in phase III studies in patients with moderately to severely active ulcerative colitis.
In the HIBISCUS I induction study, in people without prior anti-tumour necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint of inducing remission versus placebo.
However, in the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, etrolizumab did not meet its primary endpoint as a maintenance therapy compared to placebo.
Finally, in the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab also failed to meets its primary endpoint.
We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
“We are fully analysing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial programme ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participation,” he added.
Although the investigational drug failed to fully succeed in ulcerative colitis, Roche is continuing to study the drug as an induction and maintenance treatment in people with severely active Crohn’s disease, with and without prior anti-TNF treatment.
Roche will also continue to analyse the data, including secondary endpoints, and will submit the results for presentation at upcoming medical meetings.