Takeda Presents Promising Initial Results From INSPIRE Study Of Alofisel

Takeda Pharmaceutical Co. Ltd. (TAK), said on Friday that clinical remission was observed in 65% of patients with Crohn's disease and complex perianal fistulas in a phase III trial, dubbed INSPIRE, an observational post-marketing study of Alofisel.

Alofisel, a suspension of expanded allogeneic or donor-derived, adipose-derived mesenchymal stem cells (eASC), is approved in the European Union/European Economic Area, Israel, Switzerland, the United Kingdom, and Japan.

The six-month interim analysis results from INSPIRE study are consistent with the pivotal Phase 3 ADMIRE-CD study in terms of efficacy and safety of the drug, the Tokyo-headquartered firm said.

ADMIRE-CD was a randomized, double-blind, controlled, Phase 3 trial investigating the efficacy and safety of Alofisel for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn's disease.

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