Genentech, a biotechnology corporation that operates as an independent unit within Roche Group, has reportedly announced the top-line results from its Phase III clinical trial of etrolizumab in patients with moderately to severely active ulcerative colitis.
Sources cite that studies assessing etrolizumab as an induction therapy demonstrated mixed results. HIBISCUS I induction clinical study in people without prior anti-TNF (Anti-tumor Necrosis Factor) treatment apparently met the primary endpoint.
On the other hand, the HIBISCUS II induction clinical study, which comprised patients without previous anti-TNF treatment, didn’t achieve its primary endpoint.
Studies assessing etrolizumab as a maintenance therapy didn’t meet their primary endpoints. Both studies demonstrated no substantial difference in the proportion of people reaching remission with subcutaneous etrolizumab against placebo.
In the HICKORY clinical study, in patients with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but failed to meet at maintenance. Etrolizumab didn’t achieve its primary endpoint in the LAUREL clinical maintenance study in patients without previous anti-TNF treatment.
The safety outcomes of etrolizumab are in line with prior studies and no significant safety issues were recognized in the four Phase III clinical studies reported to date.
Speaking on which, Levi Garraway, M.D., Ph.D., Head and Chief Medical officer of Global Product development said that the company is disappointed with these outcomes as it understands the need for new treatment options for ulcerative colitis.
More evaluation of the data, including secondary endpoints, is currently on-going and will be submitted for presentation at forthcoming medical meetings.
The company said in the statement that investigational medicine etrolizumab continues to be evaluated in patients with moderately to severely active Crohn’s disease as induction and maintenance treatment. The company plans to assess etrolizumab in the global phase III clinical trial (BERGAMOT) and safety monitoring and open-label extension study (JUNIPER), involving over 1,100 patients with Crohn’s disease.
Moreover, the company is also evaluating other investigational drugs in inflammatory bowel diseases and is dedicated to further understanding of this disease.