Genentech announced topline results from its Phase III study program evaluating the etrolizumab in patients with moderate to severely active ulcerative colitis. 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.
The studies reported include HIBISCUS I and II: Two identical, randomized, double-blind, double-dummy, placebo-controlled, multicenter studies evaluating the efficacy (induction of remission) and safety of etrolizumab versus adalimumab and placebo in patients with moderate to severely active ulcerative colitis who have not been previously treated with anti-tumor necrosis factor (anti-TNF) agents. HICKORY: Double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of etrolizumab during induction and maintenance in patients with moderately to severely active ulcerative colitis who have been previously treated with anti-TNF agents. LAUREL: Randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy (maintenance of remission) and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who have not been previously treated with anti-TNF agents.
In the HIBISCUS I induction study, in people without prior anti-TNF treatment, etrolizumab met the primary endpoint. However, the HIBISCUS II induction study, which included people without prior anti-TNF treatment, 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.
Genentech intends to analyze the data from the four studies, including secondary endpoints.
Full data from these studies will be presented at a future medical meeting.
Genentech is continuing to evaluate etrolizumab as an induction and maintenance treatment in patients with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global Phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn’s disease.
Etrolizumab is a dual anti-integrin. It is designed to target IBD on two fronts by selectively inhibiting α4β7 and αEβ7 to control both trafficking of immune cells into the gut and their inflammatory effects on the gut lining.
About inflammatory bowel diseases and ulcerative colitis
Inflammatory bowel diseases (IBD) are a group of chronic gastrointestinal disorders affecting almost 7 million people worldwide. The two main types of IBD are ulcerative colitis (mainly affecting the colon and rectum) and Crohn’s disease (affecting the entire gastrointestinal tract). Ulcerative colitis is most commonly diagnosed in young people aged 15 to 30 years. Up to a quarter of people with ulcerative colitis will require a colectomy within ten years of diagnosis, in which all or part of the colon is removed. Symptoms of IBD can include abdominal pain and cramping, frequent and urgent bowel movements, diarrhea, leakage, rectal bleeding, weight loss, energy loss, and fatigue. About 80% of all individuals with IBD do not experience lasting remission, which can have a long-term impact on the quality of life and leave many feeling like they have little control over their daily lives.