Crohn's Disease (Pediatric)

March 21, 2016

TiGenix reported results of a phase III study of Cx601 in Crohn’s disease patients with complex perianal fistulas with inadequate response to previous therapies. ADMIRE-CD was a randomized, double-blind, placebo-controlled phase III study. In total, 212 patients were randomized in seven European countries and Israel. Patients included in this study had an inadequate response to at least one previous therapy, including anti-TNFs. Continuation of medical standard-of-care was allowed during the duration of the trial in both groups. 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. This same endpoint of combined remission has been analyzed after 52 weeks as a secondary variable. In the ITT population (n=212), Cx601 achieved statistical superiority (p=0.012) with 54.2% combined remission at week 52 compared to 37.1% in the placebo arm. In the mITT population (n=204), the combined remission at week 52 was 56.3% and 38.6% for Cx601 and placebo respectively (p=0.010). Efficacy results were robust and consistent across all statistical analyses. The week 52 data also shows a higher rate of sustained closure in those patients treated with Cx601 and in combined remission at week 24 (75.0%) compared to patients in the placebo group (55.9%). Treatment-emergent adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and placebo groups.