TiGenix has announced positive results for its phase-three trial of Cx601. | Courtesy of Shutterstock
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Jeff Gantt | Mar 10, 2016

TiGenix’s Cx601 trial shows positive results

TiGenix NV announced earlier this week that its phase-three ADMIRE-CD trial for patients with Crohn’s disease has shown that a single injection of Cx601 is vastly superior to a placebo in attaining remission at week 52 of the trial.

The ADMIRE-CD trial, which was double-blind and placebo-controlled, focused on patients suffering from Crohn’s disease with complex perianal fistulas who had insufficient responses to prior therapies, including anti-TNFs. The study, which lasted one year, established that Cx601 is safe and tolerable among patients.

The trial included 212 random patients from seven different European countries and Israel. All patients involved in the study had previous adverse responses to at least one type of therapy that included anti-TNFs.

The primary goal of the study was combined remission by the 24th week of ADMIRE-CD. Combined remission for the trial was defined as the closing of all external openings that had received treatment, which would be confirmed by an MRI. This goal was also examined at the completion of the trial in week 52.

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