Inflammatory bowel disease (IBD) new drug! Roche's double-acting anti-integration therapy etrolizumab Phase III clinical project: the results have been mixed!

August 11, 2020 // -- Roche's Gene Tek recently announced the top-line results of a phase III research project evaluating the treatment of ulcerative colitis (UC) in etrolizumab.
results of four double-blind, placebo-controlled Phase III studies conducted in patients with moderate to severe active UC who had not previously been treated with anti-tumor necrotic factor (anti-TNF) therapy showed that etrolizumab was evaluated as an inducement The results of the two studies of the guided therapy were mixed, and neither of the two studies evaluating etrolizumab as a maintenance therapy reached its primary endpoint, showing no significant difference in the proportion of patients who received remission compared to placebo by insulating etrolizumab.
in HIBISCUS I induction studies, etrolizumab reached its primary endpoint.
, hiBISCUS II induction studies did not reach the primary endpoint.
in the HICKORY study, etrolizumab reached the primary endpoint during the induction period, but not during the maintenance period.
in the LAUREL maintenance study, etrolizumab did not reach the main endpoint.
safety of etrolizumab is consistent with previous studies, and no significant safety issues have been found in the four Phase III clinical trials reported to date.
is conducting further analysis of the data, including the secondary endpoint, all of which will be presented at an upcoming medical conference.
, Chief Medical Officer and Head of Global Product Development at Roche, said: "We are disappointed with these results because we know that patients with ulcerative colitis need new treatment options.
we are conducting a comprehensive analysis of this data to understand how we respond to the needs of patients with this devastating disease.
these studies are part of the largest clinical trial ever conducted in inflammatory bowel disease, and we thank all patients, researchers and healthcare professionals for their participation.
" IBD (Photo: tsukuba.ac.jp) inflammatory bowel disease (IBD) is a group of chronic gastrointestinal diseases that affect nearly 7 million people worldwide.
two main types of IBD are ulcerative colitis (UC, which mainly affects the colon and rectum) and Crohn's disease (CD, which affects the entire gastrointestinal tract).
patients may experience unpredictable symptoms, including abdominal pain and cramps, frequent and urgent detocation, diarrhea, leakage, rectal bleeding, weight loss, energy loss, and fatigue.
80 percent of IBD patients do not receive lasting remission, which can have a long-term impact on quality of life and leave many patients feeling almost unable to control their daily lives.
UC is most common among 15-30 year olds and affects their entire future lives.
up to a quarter of UC patients need a colonectomy within 10 years of diagnosis to remove all or part of the colon.
the etrolizumab mechanism of action (Photo Source - PMID: 29178491) etrolizumab is the first study in IBD to study dual-acting anti-integration, targeting IBD from these two directions by selectively inhibiting alpha 4 beta7 and alpha E beta7, controlling the entry of immune cells into the intestine and its inflammatory effect on the intestine.
Currently, in a Global Phase III Study (BERGAMOT) and Open Label Extension and Safety Monitoring Study (JUNIPER), etrolizumab continues to be used as an induction and maintenance therapy to study patients with moderate to severe active Crohn's disease (CD), including more than 1,100 CD patients.
addition, Genetek is studying other drugs in the study of inflammatory bowel disease and is working to learn more about the disease.
it is worth mentioning that in the area of inflammatory bowel disease (IBD), Takeda Pharmaceuticals' Entervio (Angie's ®, generic name: vedolizumab, injectable vidolizumab) is the world's only intestinal selective anti-inflammatory drug, which is an intestinal selectivity Humanized monoclonal antibodies, approved by the United States and the European Union in May 2014, are used to treat adult patients with moderate to severe active ulcerative colitis (UC) and Crohn's disease (CD) who do not respond well to conventional treatment or tumor necrotizing factor alpha (TNF alpha).
Entyvio's active pharmaceutical ingredient is vedolizumab, an all-human monoclonal antibody that specific antagonizes alpha4 beta-7 integration, inhibiting the binding of alpha-4 beta-7 integrators to the intestinal mucosa cell adhesion molecule MAdCAM-1.
MAdCAM-1 is selectively expressed in the gastrointestinal blood vessels and lymph nodes.
alpha-4 beta-7 integrated protein is expressed in a group of circulating white blood cells that have been shown to play an important role in mediating inflammation in CD and UC diseases.
In China, Entyvio Intravenous Preparations (IV) were approved in March 2020 for moderate to severe active UC and CD adult patients who did not respond adequately to traditional treatments or TNF alpha inhibitors.
entered the first batch of clinically urgently needed new drugs from abroad® and received an expedite review.
Entyvio ® is currently the only intestinal selective biologic agent in the field of inflammatory bowel disease (IBD), and its clinical data show that it can work quickly and achieve long-lasting clinical remission and mucosal healing, while being safe and is a first-line biological agent recommended by international guidelines in Europe and the United States.
() Original source: Genentech Provides Update on Phase III Studies of Etrolizumab in People With Moderately to Severely Active Ulcerative Colitis.