Publication date: 15/01/2018
TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the antiinflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, announces today that the 52-week results of the Phase III ADMIRE-CD trial investigating Cx601 (darvadstrocel) have been published in Gastroenterology1.
This publication in one of the leading scientific publications in the Gastroenterology field provides further validation of the ADMIRE-CD trial results and highlights that Cx601 maintained long-term remission of treatment refractory complex perianal fistulas in patients with Crohn’s disease. The results showed that a single injection of Cx601 was statistically superior to control in achieving combined remission of perianal fistulas at week 52. The one-year data also confirmed the favorable safety and tolerability profile of Cx601 reported at week 24.
The data formed part of TiGenix’ Marketing Authorization Application for Cx601 for which it recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Cx601 is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. 2
Dr. Mary Carmen Diez, VP Medical Affairs and Commercialization of TiGenix, said:
“We had previously announced the topline results from our 52-week analysis. These data showed a sustained effect of Cx601 treatment and supported our Marketing Authorization Application in Europe. We are pleased to see the full results published in such a prestigious journal, emphasising the quality of the ADMIRE-CD trial and the strength of the data supporting the development of Cx601.”
Complex perianal fistulas are considered one of the most disabling complications of Crohn’s disease3 and can cause intense pain4 and swelling, infection and incontinence.5 Despite available therapies and surgical advancements, they currently remain challenging for clinicians to treat6 and have a significant negative impact on patient quality of life. 4
TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical company developing novel therapies for serious medical conditions by exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells.
TiGenix´ lead product, Cx601, has successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas - a severe, debilitating complication of Crohn’s disease. Cx601 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. TiGenix has entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the U.S. TiGenix’ second adipose-derived product, Cx611, is undergoing a Phase I/II trial in severe sepsis – a major cause of mortality in the developed world. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain) and Cambridge, MA (USA). For more information, please visit http://www.tigenix.com.