Belgium-based biopharmaceutical company TiGenix has revealed the 52-week results from a Phase III trial evaluating Cx601 (darvadstrocel) for the treatment of complex perianal fistulas in Crohn’s disease.
Results of the ADMIRE-CD trial demonstrated that a single injection of Cx601 was statistically superior to control combined remission of perianal fistulas at week 52.
It also confirmed the favourable safety and tolerability of Cx601 reported at week 24 of the trial.
The newly published results are part of TiGenix’s marketing authorisation application for Cx601, which the company recently obtained a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
TiGenix Medical Affairs and Commercialization vice-president Dr Mary Carmen Diez said: “We had previously announced the topline results from our 52-week analysis.
“This data showed a sustained effect of Cx601 treatment and supported our marketing authorisation application in Europe.”
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TiGenix aims to develop Cx601 as a treatment for 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.
Complex perianal fistulas are considered to be one of the most disabling complications of Crohn’s disease, in addition to causing intense pain and swelling, infection and incontinence.
In spite of the availability of various treatments, clinicians are still finding it challenging to treat fistulas.