TiGenix’s ammended trial for Cx601 Chron’s disease accepted in US, kicks off in next four months

Belgian-headquartered biopharmaceutical company TiGenix has received positive feedback from the U.S. Food and Drug Administration (FDA) for its improved phase III trial for the treatment of complex perianal fistulas in Crohn’s disease patients.

The Belgian company got FDA’s acceptance for a a Special Protocol Assessment (SPA) for a pivotal Phase III study for Biologics License Application (BLA) in the U.S. Later, the European Phase III study of Cx601 (ADMIRE-CD) got positive results. After that, TiGenix submitted a Marketing Authorization Application to the European Medicines Agency in March 2016. After publishing this additional data, TiGenix submitted a series of technical improvements to be considered by the FDA regarding the previously endorsed protocol, the company said.

According to TiGenix, the Agency has agreed to an improved protocol for the global Phase III trial of Cx601. With these current improvements, the FDA OK’d filing the BLA on the efficacy and safety follow-up of patients assessed at week 24, instead of week 52. The FDA has also made it easier by accepting fewer patients than planned in the study, and has endorsing a broader target population for the recruitment.

All this could bring approval a year earlier than planned, said Dr. Maria Pascual, VP Regulatory Affairs & Corporate Quality of TiGenix.

“We are pleased to have had the opportunity to meet with the FDA and receive the Agency endorsement for our proposals for this improved protocol,” said Dr. Pascual

The trial for the U.S. registration of Cx601 should kick off in the next four months, TiGenix said adding that it is looking for ways to accelerate the submission and review process for its future BLA.