Phase III ADMIRE-CD clinical trial of Cx 601 (adipose-derived stem cells) shows long term remission in Crohn's disease- Takeda/TiGenix

Takeda Pharmaceutical Company and TiGenix announced new data from the Phase III ADMIRE-CD clinical trial, which indicated that Cx 601, a suspension of allogeneic adipose-derived stem cells (eASC), maintained long-term remission of treatment refractory complex perianal fistulas in patients with Crohn's disease over 52 weeks. The ADMIRE-CD trial is a randomized, double-blind, controlled, Phase III trial, designed to investigate the efficacy and safety of the investigational compound Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease.

Patients were randomized to a single administration of Cx601 cells or placebo (control), both added to standard of care. A significantly greater proportion of patients in the Cx601 group versus in the control group achieved clinical and radiological combined remission (56.3% and 38.6%; p=0.010), and clinical remission (59.2% and 41.6%; p=0.013) at week 52 in the modified intention-to-treat population (mITT). Of those mITT patients who had shown combined remission at week 24, a greater number in the Cx601 group versus the control group reported no relapse at week 52 (75.0% and 55.9%).

The rates and types of treatment related adverse events (non-serious and serious) and discontinuations due to adverse events were indicated to be similar in both groups (Cx601: 20.4%; control: 26.5%). Results were presented at the 12th Congress of the European Crohn's and Colitis Organisation (ECCO).