Takeda trial for Crohn’s Perianal Fistulas treatment misses primary endpoint


said Tuesday its trial of darvadstrocel in the treatment of complex Crohn’s Perianal Fistulas didn’t meet its primary endpoint based on topline data.

The pharmaceutical company said the Phase 3 trial assessing the treatment, which goes by brand name Alofisel, had a primary endpoint of combined remission at 24 weeks.

The company said it was evaluating the financial effect of the study results, which may include impairment loss for intangible assets in the fiscal quarter ended Sept. 30.

Takeda said Alofisel had already been approved in the European Union, Israel, Switzerland, Serbia, the U.K. and Japan based on data from a previous trial, with approval in Japan also based on an additional trial.

Full results from the study will be presented at a future medical meeting or published in a journal.

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