Takeda and TiGenix announced positive results from the Phase 3 ADMIRE-CD trial of Cx601 for the treatment of complex perianal fistulas in patients with Crohn’s disease. Study findings were published in The Lancet.
ADMIRE-CD was a 24-week, randomized, double-blind, placebo-controlled, Phase 3 trial evaluating the efficacy and safety of a single treatment of Cx601 in patients with perianal fistulas associated with Crohn’s disease. The primary endpoint was combined remission at Week 24, defined as clinical assessment of closure of all treated external openings draining at baseline, despite gentle finger compression, and absence of collections >2cm confirmed by MRI.
Study data showed that a significantly greater proportion of patients treated with Cx601 achieved the primary endpoint compared to placebo. In the ITT population, 50% of patients in the Cx601 group achieved combined remission at Week 24 vs. 34% in the placebo group (97.5% CI 0.2–30.3; P=0.024). Additionally, 51% of Cx601-treated patients achieved combined remission in the mITT population compared to 36% of placebo-treated patients (97.5% CI 0.5–31.2; P=0.021).
The study also assessed the severity of perianal Crohn’s disease at baseline through the Perianal Disease Activity Index (PDAI). A similar PDAI score was observed between the Cx601 and the placebo groups at baseline, however, improvement in PDAI was significantly greater for Cx601 at Week 6, 12 and 18. The overall rate of adverse events was comparable between the Cx601 and placebo groups.
Cx601 is an investigational suspension of allogeneic expanded adipose-derived stem cells (eASC) being developed as an intra-lesion injection for the treatment of complex perianal fistulas in patients with Crohn’s disease with an inadequate response to at least one conventional or biologic therapy.