Takeda’s US ambitions for Alofisel take a hit on key study failure

18 Oct 2023
firstwordpharma.com
Phase 3Cell TherapyClinical ResultDrug ApprovalPhase 2
Takeda said Wednesday that a Phase III study of Alofisel (darvadstrocel) for the treatment of complex Crohn’s perianal fistulas (CPF) failed to meet its primary endpoint of combined remission at 24 weeks. The ADMIRE-CD II trial was designed to support a US marketing application for the allogeneic stem cell therapy, which was gained through the purchase of TigenixTigenix in 2018.
“We are disappointed with this outcome,” remarked Chinwe Ukomadu, head of Takeda’s GI and inflammation therapeutic area unit, adding “we believe there are valuable lessons to learn from ADMIRE-CD II.” Full results of the study will be presented at a future medical meeting or published in a peer-reviewed journal.
Alofisel gained approval in Europe in 2018 for the treatment of CPF - and is also authorised in Japan - based on findings from the Phase III ADMIRE-CD trial. Results from that study showed that 51.5% of patients in the Alofisel group achieved the primary endpoint of combined remission at a 24 week follow-up, which was significantly more than the 35.6% in the control arm, with the benefit maintained over 52 weeks.
ADMIRE-CD II kicked off in 2017 to investigate the efficacy and safety of a single administration of Alofisel, also known as Cx601, for the treatment of complex perianal fistulas in Crohn's disease patients. The FDA agreed to the study design, with results at 24 weeks, instead of week 52, from a broader patient population set to make up a marketing application.
Takeda said Wednesday that it is “continuing to assess the financial impacts” of the ADMIRE-CD II failure, including impairment losses for intangible assets.
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