Takeda Pharmaceutical (TYO:4502) touted top-line data today from its pivotal Phase III Visible 1 trial evaluating an investigational subcutaneous formulation vedolizumab as a maintenance therapy for adults with moderate to severe ulcerative colitis.
The trial specifically focused on patients who experienced a clinical response at six weeks following two doses of open-label vedolizumab IV induction therapy. Takeda reported that a statistically significant proportion of participants receiving a subcutaneous dose of the drug at week 6 and every two weeks following achieved clinical remission after 52 weeks compared to the placebo group.
The company also noted that the safety data were consistent with the known safety profile of vedolizumab.
“Meeting the primary endpoint of the Visible 1 trial marks an exciting milestone in our approach to developing new ways to meet the needs of the ulcerative colitis patient community,” Dr. Asit Parikh, head of Takeda’s gastroenterology business unit, said in prepared remarks.
“These results are encouraging and build on vedolizumab’s robust clinical profile with more than 200,000 patient years of exposure. We plan to discuss these data with health authorities with the aim of bringing this innovative treatment option to patients,” Parikh added.