TiGenix (Euronext Brussels: TIG ) has announced positive 52-week Phase III results of Cx601 in complex perianal fistulas in Crohn's disease patients.
It found that a single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 52 in the ADMIRE-CD trial patients with inadequate response to previous therapies, including anti-TNFs. The one-year data also confirm the favorable safety and tolerability profile of Cx601 already reported at week 24.
TiGenix chief medical officer Dr Marie Paule Richard said: "We are delighted with the remarkable consistency of these results with respect to those reported at 24 weeks. In particular, the 75% persistence in the combined remission from week 24 to week 52 confirms Cx601 as a promising therapeutic solution for a hard to treat population that is refractory to existing treatments including anti-TNFs. The improvement brought by Cx601 compared to the best standard of care available could make a real difference to the life of patients suffering from this chronic disease".
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