Takeda and TiGenix' stem cell therapy has shown promise in inducing remission of perianal fistulas in patients with Crohn's disease, according findings of a late-stage trial published in The Lancet.
The Phase III ADMIRE-CD trial assessed the safety and efficacy of a single shot of Cx601, a suspension of allogeneic adipose-derived stem cells (eASC) injected intra-lesionally to treat complex perianal fistulas in patients with Crohn's disease with an inadequate response to at least one conventional or biologic therapy.
According to 24-week data, a significantly greater proportion of patients in the Cx601 group versus the placebo group achieved the primary endpoint of combined remission - determined by both clinical and radiological assessment - at week 24 in the intent to treat population, the results showing 50 percent and 34 percent, respectively.
On the safety side, treatment-emergent adverse events and discontinuations due to adverse events were comparable between Cx601 and placebo arms.
Also, improvement in the Perianal Disease Activity Index (PDAI) was significantly greater in the Cx601 group, while the mean total score at week 24 with Cx601 (4.4) was close to the threshold for inactive perianal disease (PDAI<4) at which patients do not need medical or surgical treatment.
Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract that affects around five million patients around the globe, often causing complex perianal fistulas for which there are limited treatment options.
Cx601 carries orphan designation in Europe, where the therapy is currently being reviewed by regulators, with a decision expected sometime next year.