TiGenix Presents Positive Results of Potential Crohn’s Therapy, Announces Phase 3 Study

TiGenix Presents Positive Results of Potential Crohn’s Therapy, Announces Phase 3 Study

TiGenix will present positive results of Cx601 to treat complex perianal fistulas in Crohn’s disease patients at the upcoming World Congress of Gastroenterology ACG 2017 meeting in Orlando, Florida.

The company will discuss results from its 52-week ADMIRE-CD Phase 3 trial (NCT01541579) and present the upcoming ADMIRE-CD-II (NCT03279081) — a global Phase 3 clinical trial designed to support a future biologic license application to the U.S. Food and Drug Administration (FDA).

The presentation, “One-year Efficacy and Safety of a Single Dose of Cx601, Allogeneic Expanded Adipose-Derived Mesenchymal Stem Cells, for Complex Perianal Fistulas in Crohn’s Disease: Long-Term Results of a Phase 3, Randomized, Double-Blind Clinical Trial” will take place Oct. 18 at 10 a.m.

TiGenix, based in Belgium, exploits the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop therapies for serious medical conditions. Its lead product to treat Crohn’s patients with complex perianal fistulas is Cx601, a local administration of allogeneic expanded adipose-derived stem cells (eASCs).

Last year, The Lancet published 24-week data of ADMIRE-CD under the title “Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomised, double-blind controlled trial.” It showed that both the primary endpoint and the safety and efficacy goals were met.

In May 2017, TiGenix published the results of a 52-week extension period with more positive results. Only 25 percent of patients whose condition was resolved in the first 24 weeks of treatment saw it recur by week 52. That compared to a 44.1 percent recurrence rate in the placebo group.

The presentation will focus on the robust set of data collected from these trials. Based on the positive results, TiGenix submitted a marketing authorization application to the European Medicines Agency (EMA). It expects an opinion from the Committee for Medicinal Products for Human Use later this year. The European Union had already granted Cx601 orphan drug status in 2009.

“We are pleased that the positive 52-week results from the ADMIRE-CD Phase III trial demonstrating the long-term efficacy and safety of Cx601 for treatment-refractory complex perianal fistulas in Crohn’s disease patients has been selected for an oral presentation at the WCOG/ACG meeting,” Mary Carmen Diez, vice president of medical affairs and commercialization at TiGenix, said in a press release. “These data have been used to further support our marketing authorization application for TiGenix, for which we anticipate a CHMP opinion in 2017.”