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10Month17Date, Takeda Pharmaceutical Company Limited announced evaluationAlofisel® （darvadstrocel）Treatment of Complex Perianal Fistulas in Crohn's Disease (CPF）Efficacy and Safety of3PeriodADMIRE-CD IIThe study did not reach24The primary endpoint of clinical remission at week.darvadstrocelThe safety profile was consistent with previous study results, with no new safety signals identified.Takeda Pharmaceutical Company Limited did not announce on TuesdaydarvadstrocelDetailed data of the trial, but stated that it is currently"Continue to assess the financial impact of the study results, including impairment losses on intangible assets."ADMIRE-CD II The full results of the trial will be presented at a future medical conference or published in a journal.
AlofiselHas been approved in the EU, Israel, Japan, Serbia, Switzerland, and the UK, based on prior treatment for cystic pulmonary fibrosis that was ineffective.（CPF) Active research conducted on patients, includingADMIRE-CDAndDarvadstrocel-3002Takeda has not stopped its research on the drug either.--According to the press release, there are currently approximately800Patients participated in the program for complexCPFPatient'sINSPIREObservational Study.
Head of Gastroenterology and Inflammation Therapeutic Area at Takeda Pharmaceutical Company LimitedChinwe Ukomadu Said in a statement:“Although we are disappointed with this result, we recognize that, for complexityCPF The medical research on refractory diseases such as [...] remains challenging.”ADMIRE-CDThe study helped the drug gain approval in countries outside the United States, and it achievedCPFPatient24The primary endpoint of comprehensive relief over time. In212Among adult patients,51.5%of patients achieved comprehensive remission, while the remission rate in the control group was35.6%，PThe value is0.021，56.3%The remission rate of the patients was maintained.52Week.By569Patients participated, placebo-controlledADMIRE-CD-IIThe primary endpoint of the trial was also24Comprehensive remission was achieved at the same time every week.
This is Takeda's second Crohn's disease failure case in the past six months. This year5In the month, Takeda concluded2018Year and French Biotechnology CompanyEnterome SACollaboration to develop small-molecule drugs for the treatment of Crohn's diseasesibofimlocTakeda pointed out that, in a study on patients with postoperative ileitis,IIaIn the trial period, the drug did not reach the primary endpoint. Ileitis after surgery refers to the doctor removing the diseased tissue at the end of the small intestine, which usually significantly affects the treatment of Crohn's disease.About Alofisel®
Alofisel®（darvadstrocel) is an expanded allogeneic (or donor-derived) adipose mesenchymal stem cell (eASC) dispersion, for the treatment of non-active or mildly active luminal Crohn's disease (CD) Complex conditions in adult patientsCPFThis is the first allogeneic stem cell therapy to receive centralized marketing authorization in the EU, and also the first expanded human allogeneic adipose-derived mesenchymal stem cell therapy to be approved in Japan.Reference: Company official website
