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Monday, November 9, 2020

Arena Pharma's etrasimod flunks mid-stage dermatitis study

  • Arena Pharmaceuticals (NASDAQ:ARNA) slumps 20% after hours in reaction to results from a Phase 2b clinical trial, ADVISE, evaluating etrasimod (APD334) in patients with moderate-to-severe atopic dermatitis (AD).
  • The study failed to achieve the primary endpoint of percent change in Eczema Area and Severity Index (EASI) at week 12 versus placebo.
  • Between weeks 4-8, the trial was impacted by "unwarranted" dose interruption (not related to drug safety) in 19% (n=9) of the participants in the 2 mg arm. Adjusting for this interruption, via a post-hoc completer analysis with participants receiving full therapeutic exposure, etrasimod 2 mg showed statistically significant effect on the EASI score compared to placebo (weeks 4 and 12), EASI-75 at week 4, vIGA at week 12 and pruritis through week 8.
  • About a third of the patients in the 2 mg group achieved clear or almost clear skin.
  • No new safety signals were observed.
  • Phase 3 studies are next up.
  • Management hosted a conference call at 4:30 pm ET to discuss the results.
  • https://seekingalpha.com/news/3633965-arena-pharmas-etrasimod-flunks-mid-stage-dermatitis-study-shares-down-20

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