Takeda and TiGenix announce positive findings from Crohn’s disease trial

Takeda and TiGenix have announced the publication of new clinical trial data demonstrating the strong performance of their new Crohn's disease therapy Cx601.

Published in The Lancet, 24-week results from the phase III ADMIRE-CD trial have demonstrated the efficacy and safety of a single treatment of Cx601 for addressing complex perianal fistulas in Crohn's disease patients.

It was shown that a significantly greater proportion of patients receiving Cx601 achieved the primary endpoint of combined remission at week 24 compared to those on placebo, while disease activity levels were also improved.

Cx601 is a suspension of allogeneic adipose-derived stem cells injected intralesionally for the treatment of complex perianal fistulas in patients with Crohn’s disease who have experienced an inadequate response to at least one conventional or biologic therapy.

TiGenix signed a licensing agreement with Takeda last month giving the latter company the exclusive right to develop and commercialise Cx601 for complex perianal fistulas in Crohn’s disease outside the US.

Data from this pivotal phase III trial is being used to support Takeda's ongoing efforts to secure European regulatory approval of the drug in this indication.