Subcutaneous form of Entyvio trial hits goals

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic Entyvio (vedolizumab) as maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD) who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.

In evaluating the primary endpoint of the trial, a statistically-significant proportion of patients receiving vedolizumab SC achieved clinical remission at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50. Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.

“Meeting the primary endpoint of the VISIBLE 2 study marks a crucial step in our efforts to help patients with Crohn’s disease as to how they may receive treatment with vedolizumab, whether that is intravenously or subcutaneously. These data, alongside the pivotal VISIBLE 1 results in ulcerative colitis, provide a more comprehensive picture of the new investigational subcutaneous formulation of vedolizumab as maintenance therapy for both ulcerative colitis and Crohn’s disease,” said Dr Asit Parikh, head of Takeda’s gastroenterology therapeutic area unit.