Real-World Analysis Show Takeda's Alofisel Clinical Remission Rate At Six-Months

Takeda Pharmaceutical Co Ltd TAK announced the first six-month interim analysis results from INSPIRE study evaluating the Real-World Effectiveness and Safety of Alofisel (darvadstrocel).

• The study demonstrated clinical remission in 65% of patients in both cohorts evaluated at six months, with Crohn's disease (CD) and complex perianal fistulas.
• Data were presented at the European Crohn's and Colitis Organisation (ECCO) 2022 Congress.
• Clinical response was observed in 73% (57/78) and 74% (51/69) of patients in the All Treated (AT) and Treated Per Protocol (PP) cohorts, respectively.
• Also See: FDA Rejects Takeda's Eosinophilic Esophagitis Candidate, Asks For Additional Study.
• Changes in CD activity post-treatment were minimal. Of the 205 patients with complete treatment data, 20% (41/205) had one or more adverse events, and 9.3% (19/205) had one or more serious adverse events.
• There were no reports of ectopic tissue formation and no deaths.
• Price Action: TAK shares are down 0.07% at $15.25 during the market session on the last check Friday.