TiGenix NV has achieved positive results from its ADMIRE-CD Phase III clinical trial of Cx601 for the treatment of complex perianal fistulas in patients with Crohn’s disease. The company will present the results at the World Congress of Gastroenterology at the American Congress of Gastroenterology 2017 Annual Scientific Meeting (WCOG/ACG) in Orlando, Florida, USA.
Dr. Mary Carmen Diez, Vice President, Medical Affairs and Commercialisation at TiGenix is pleased with the positive 52-week results from the ADMIRE-CD Phase III trial which showed the long-term efficacy and safety of Cx601 for treatment-refractory complex perianal fistulas in Crohn’s disease patients. She said that the data have been used to further support the company’s marketing authorisation application for TiGenix. “We anticipate a CHMP opinion in 2017. In parallel, we continue to progress our global pivotal Phase III trial for a future filing in the US,” she said.