Takeda will release complete Phase III data at a future scientific conference and is planning on seeking regulatory approval for the investigational formulation.
Takeda Pharmaceutical’s Phase III Crohn’s disease trial evaluating an investigational subcutaneous formulation of Entyvio (vedolizumab) as a maintenance therapy for patients with moderately or severely active disease hit the mark, the company announced this morning.
The VISIBLE 2 trial assessed Entyvio as a maintenance treatment for Crohn’s patients who achieved clinical response at six weeks following two doses of open-label intravenous Entyvio at weeks zero and two. A clinical response was defined as a 70 point or greater decrease in Crohn’s Disease Activity Index (CDAI) score from baseline. For those patients who qualified, Takeda said a statistically significant proportion of patients who received the subcutaneous formulation of Entyvio achieved clinical remission at 52 weeks compared to placebo. Patients in the trial were dosed every two weeks. Clinical remission is defined as a CDAI score less than or equal to 150 at week 52.
The VISIBLE 2 study included 644 participants, all of whom had an inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or tumor necrosis factor-alpha (TNFα)-antagonist therapy prior to being enrolled
Asit Parikh, head of Takeda’s Gastroenterology Therapeutic Area Unit, said hitting 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.” Data from the VISIBLE 2 trial, alongside VISIBLE 1, which assessed the subcutaneous version of Entyvio in ulcerative colitis, provides a “more comprehensive picture” of the new formulation as a maintenance therapy, Parikh said. Both ulcerative colitis and Crohn’s disease are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract that are often progressive in nature.
The VISIBLE 1 study demonstrated the subcutaneous version of Entyvio generated a 46.2% clinical remission rate in ulcerative colitis patients at week 52. That was in comparison to a 14.3% response for placebo. In May, the U.S. Food and Drug Administration accepted Takeda’s Biologics License Application for the subcutaneous formulation of Entyvio as a maintenance therapy for ulcerative colitis based on the VISIBLE 1 study. Takeda said it plans to make the subcutaneous formulation available in both pre-filled syringe and pen options.
Complete results of the VISIBLE 2 trial will be shared at a future scientific trial, Takeda said. The company also plans to provide the results from the trial to regulatory authorities in hopes of potential approval of the subcutaneous formulation as a maintenance therapy. The subcutaneous formulation of vedolizumab forms part of Takeda’s ongoing commitment to meet the individual preferences of patients worldwide, the company said.
Adverse events were consistent with the known safety profile of the IV formulation of Entyvio, and no new signals were identified.
