Takeda's Highest Dose Psoriasis Candidate Can Potentially Beat Bristol Myers' Approved Drug, Analyst Says

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  • Takeda Pharmaceutical Co Ltd TAK announced results from a Phase 2b clinical trial of TAK-279 (NDI-034858) in patients with moderate-to-severe plaque psoriasis. 
  • The study met its primary and secondary endpoints, with a statistically significant greater proportion of TAK-279 patients achieving Psoriasis Area and Severity Index (PASI) 75, 90, and 100 in the 5mg, 15mg, and 30mg dosing arms compared to placebo at 12 weeks. 
  • A significantly greater proportion of TAK-279 patients achieved PASI 75 (44%, 68%, 67%; 5mg, 15mg, 30mg, respectively) versus placebo (6%).
  • PASI 90 scores of 21%, 45%, 46%; 5mg, 15mg, 30mg, respectively, for TAK-279 versus placebo (0%) and PASI 100 (10%, 15%, 33%; 5mg, 15mg, 30mg, respectively) versus placebo (0%).
  • A significantly greater proportion of TAK-279 patients achieved Physician Global Assessment (PGA) scores of 0/1 (27%, 49%, 52%; 5mg, 15mg, 30mg, respectively) or 0 (10%, 15%, 33%; 5mg, 15mg, 30mg, respectively) versus placebo (4% and 0% at 30mg], respectively) at 12 weeks.
  • No statistically significant differences in PASI or PGA response rates were seen in the TAK-279 2mg arm (18%, 2%, 10%, 2%; PASI 75, PASI 100, PGA 0/1, PGA 0, respectively) compared to the placebo.
  • Takeda will initiate a Phase 3 study of TAK-279 in psoriasis in FY2023. Takeda expects topline results from a Phase 2b study in psoriatic arthritis in FY2023.
  • Though many might claim that the results look superior to Bristol-Myers Squibb Co's BMY Sotyktu Phase 3 data, William Blair writes that comparisons with the Phase 3 Sotyktu data are more appropriate and show many similarities. 
  • Takeda appears more likely to take the highest dose into Phase III trials, which the analyst says has the potential to drive higher PASI100 rates than the approved dose of Sotyktu. 
  • Price Action: TAK shares are down 0.43% at $16.32 on the last check Monday.
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