Dermavant Presented Long-Term Results of Tapinarof in P-III PSOARING 3 Study for the Treatment of Plaque Psoriasis at EADV

October 1, 2021 Auto Bot Clinical Trials, Dermavant, P-III, Plaque Psoriasis, tapinarof 0

Shots:

  • The P-III PSOARING 3 LTE study evaluates tapinarof (1%, qd) vs vehicle-controlled cream in 763 patients with PsO for ~40wks. & a 4wks. safety follow-up period
  • The results showed an improvement in efficacy @12wks., 58.2% of patients with PGA score ≥2 achieved a PGA score of 0 or 1 & 40.9% achieved complete disease clearance, the median duration of remitting effect (~4mos.) in patients with PGA score of 0, DoR (52wks.), TEAEs were consistent with interim analysis & no new safety signals were identified
  • Additionally, therapy is well tolerated & a safety profile was consistent with previous interim analysis. The FDA accepts an application with an anticipated PDUFA date in Q2’22

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