Takeda’s stem cell treatment Alofisel flunks phase 3 trial in Crohn's complication

After trimming an early-stage Crohn’s disease candidate from its pipeline this year, Takeda is dealing with the failure of another of its therapies in a related indication.

Alofisel (daradstrocel), a stem cell therapy designed to treat one of the most debilitating complications of Crohn’s—complex perianal fistulas (CPF)—has come up short in a phase 3 trial.

In the 569-patient ADMIRE-CD II study, Alofisel did not meet its primary endpoint of combined remission at 24 weeks. Takeda did not report the full data, saving the reveal for a future medical meeting or a peer-reviewed journal, the Japan-based company said.

“While we are disappointed with this outcome, we recognize that medical research for difficult-to-treat conditions such as complex CPF remains challenging,” Chinwe Ukomadu, Takeda’s head of the GI & inflammation therapeutic area unit, said in a release. “We believe there are valuable lessons to learn from ADMIRE-CD II.”

Takeda did not reveal its plan for Alofisel as it continues to “assess the financial impacts of the study results, including impairment loss for intangible assets,” the company said. Any potential revisions to the company's forecast for the fiscal year will be announced during its second-quarter earnings call on Oct. 26.

Around 1 in 3 Crohn's patients develop a fistula, or a narrow tunnel that connects an organ to another part of the body. For patients with CPF, the fistulas form near the anus.

Alofisel is approved in the U.K. and the European Union for patients with CPF who haven’t responded to previous therapy. The nods were based on results from the 212-patient ADMIRE-CD study, which showed remission rates of 51.5% for treated patients versus 35.6% for the control group after 24 weeks. 

Alofisel also was endorsed in Takeda's’ home country, supported by positive data from the Darvadstrocel-3002 trial, which was conducted in Japan.

Earlier this year, Takeda grounded Crohn's prospect sibofimloc, an FimH blocker, which was previously set for a phase 2 trial before it was terminated because of a lack of enrollees.