Takeda's Alofisel flops in Phase III trial

Japanese drugmaker Takeda (TYO: 4502) has announced that the Phase III ADMIRE-CD II study of Alofisel (darvadstrocel) in complex Crohn’s perianal fistulas (CPF) failed to meet its primary endpoint of combined remission at 24 weeks, based on topline data.

Chinwe Ukomadu, head of the Gastro-Intestinal and Inflammation Therapeutic Area Unit at Takeda, said: “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.”

Alofisel is approved in the European Union, Israel, Switzerland, Serbia and the UK for the treatment in adult patients with complex CPF with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.