Phase III study of Cx601 (stem cell implementation) in Crohn's meets primary endpoint- TiGenix

TiGenix announced that its lead compound Cx601 met the primary endpoint in the Phase III ADMIRE-CD trial in Crohn's disease patients with complex perianal fistulas. A single injection of Cx601 (stem cell implementation) was statistically superior to placebo in achieving combined remission at week 24 in patients with inadequate response to previous therapies, including anti-TNFs. The study results also confirm the favourable safety and tolerability profile of Cx601.

In total, 289 patients were recruited across 50 active sites in 7 European countries and Israel. The study primary endpoint was combined remission at week 24, defined as closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI. In the Intention To Treat population (n=212), Cx601 achieved statistically significant superiority (p<0.025) with 49.5% combined remission at week 24 compared to 34.3% in the placebo arm. In the modified ITT population (n=204), the combined remission rates at week 24 were 51.5% and 35.6% for Cx601 and placebo, respectively (p<0.025). These results translate into an observed relative risk of 1.44, meaning that patients receiving Cx601 had 44% more chance of achieving combined remission than placebo patients.

Efficacy results were robust and consistent across all statistical populations. Treatment-emergent adverse events and discontinuations due to adverse events were comparable between Cx601 and placebo arms. Full efficacy and safety results will be presented at the 11th Congress of the European Crohn's and Colitis Organisaton, March 2016.