Takeda and TiGenix announce successful trial of Crohn’s disease drug

pharmafile | February 17, 2017 | News story | Medical Communications, Sales and Marketing Takeda, TiGenix 

Takeda and TiGenix announced Phase 3 results from a trial looking into the investigational compound Cx601, a treatment for refractory complex perianal fistulas in sufferers of Crohn’s disease. The positive results saw patients in the Cx601 group almost double the rates of clinical and radiological combined remission. The results justify Takeda’s decision to exercise its right to commercialise the drug outside of the US.

The treatment involves a suspension of allogeneic expanded adipose-derived stem cells, and was tested in the form of a single treatment alongside standard therapy. The trial saw Cx601 cells tested against a placebo control group, with Cx601 achieving 56.3% clinical and radiological combined remission against 38.6%, and clinical remission at 59.2% against 41.6% at the 52-week mark. The patients who had shown combined remission at the 24-week mark, displayed a greater proportion of no relapse against the placebo group, with 75.0% against 55.9%.

“These data highlight that the efficacy and safety of a single administration of Cx601 were maintained during one year of follow up,” said Marie Paule Richard, Chief Medical Officer at TiGenix. “It is important to also note that the definition of combined remission used in the ADMIRE-CD study, which includes both clinical and radiological assessment by MRI, is more stringent than the criteria commonly used in previous large scale, randomized clinical trials evaluating perianal fistulas in Crohn’s disease, based only on clinical assessment.”

Takeda was keen to stress that current therapies for perianal fistulising Crohn’s disease often come with severe side-effects while the rate of adverse events during the clinical trial were equivalent to the control – 20.4% in the Cx601 group and 26.5% in the control group.

TiGenix has already submitted the Marketing Authorisation Application to the EMA for Cx601 and expects to receive approval for the drug during the course of this year.

Ben Hargreaves

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