Takeda, following its decision to remove an early-stage Crohn’s disease candidate from its pipeline earlier this year, is now contending with the setback of another therapeutic failure in a related area.
Alofisel, a stem cell therapy specifically developed to address one of the most debilitating complications associated with Crohn’s disease—complex perianal fistulas (CPF)—has yielded disappointing results in a phase 3 trial.
In the extensive ADMIRE-CD II study involving 569 patients, Alofisel failed to meet its primary endpoint, which aimed to achieve combined remission at the 24-week mark. While Takeda has not yet disclosed the full data, they have chosen to reserve the details for release at an upcoming medical conference or through a peer-reviewed journal.
“While we are disappointed with this outcome, we recognize that medical research for difficult-to-treat conditions such as complex CPF remains challenging. We believe there are valuable lessons to learn from ADMIRE-CD II.”
– Chinwe Ukomadu, Takeda’s head of the GI & inflammation therapeutic area unit
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Takeda has not revealed its strategy for Alofisel as yet, as they are still in the process of evaluating the financial implications of the study results, including potential impairment losses for intangible assets. Any adjustments to the company’s fiscal year forecast will be unveiled during its second-quarter earnings call scheduled for October 26.
Notably, approximately one in three Crohn’s disease patients develops fistulas, which are narrow tunnels connecting different body parts or organs. For individuals with CPF, these fistulas typically form near the anus. Alofisel had previously received approval in the United Kingdom and the European Union for treating CPF in patients who had not responded to prior therapies. These approvals were based on outcomes from the ADMIRE-CD study, involving 212 patients, which demonstrated remission rates of 51.5% for treated patients versus 35.6% for the control group after 24 weeks.
Furthermore, Alofisel had garnered endorsement in Takeda’s home country, supported by favorable results from the Darvadstrocel-3002 trial conducted in Japan. This setback with Alofisel follows Takeda’s earlier decision to halt the development of sibofimloc, a Crohn’s disease prospect that had previously been slated for a phase 2 trial but was discontinued due to a lack of participant enrollment.
