Takeda said the safety profile of Alofisel remained in line with previous research, with no new safety concerns emerging during the study
Takeda’s global headquarters in Tokyo. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has disclosed that the Phase 3 ADMIRE-CD II study, which was conducted to evaluate the effectiveness and safety of Alofisel (darvadstrocel) for treating complex Crohn’s Perianal Fistulas (CPF), did not achieve its primary endpoint of combined remission at the 24-week mark, as indicated by preliminary findings.
Nevertheless, it is noteworthy that the safety profile of darvadstrocel remained in line with previous research, with no new safety concerns emerging during the study.
Takeda GI & Inflammation Therapeutic Area Unit Chinwe Ukomadu said: “While we are disappointed with this outcome, we recognise 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 and are grateful to the patients and investigators who made this important research possible.”
The comprehensive results of the study will be made available at an upcoming medical conference or will be published in a peer-reviewed journal.
Alofisel, or darvadstrocel, has received approval in the European Union, Israel, Switzerland, Serbia, the UK, and Japan, based on positive outcomes from the previously conducted ADMIRE-CD study. In the case of the approval in Japan, it was also supported by favourable results from the Japanese study, Darvadstrocel-3002.
Furthermore, an ongoing observational study, INSPIRE, has recruited around 800 patients to evaluate the real-world effectiveness and safety of Alofisel in individuals with complex Crohn’s Perianal Fistulas.
Takeda is currently evaluating the financial implications of the study’s findings, including potential impairment losses for intangible assets, for the fiscal quarter ending on 30 September 2023.
Any adjustments to the consolidated forecast for the fiscal year ending on 31 March 2024 (FY2023) will be disclosed during Takeda’s second-quarter earnings call, scheduled for 26 October 2023.
Alofisel, or darvadstrocel, is a dispersion of expanded allogeneic (donor-derived) adipose-derived mesenchymal stem cells (eASC) designed for the treatment of complex Crohn’s Perianal Fistulas in adult patients with non-active or mildly active luminal Crohn’s disease (CD).
It holds the distinction of being the first allogeneic stem cell therapy to receive centralised marketing authorisation approval in the European Union and the first approved therapy of its kind using expanded human allogeneic adipose-derived mesenchymal stem cells in Japan.