Arcutis Shares Gain On Positive Phase 3 Data On Roflumilast Foam In Scalp, Body Psoriasis

  • Arcutis Biotherapeutics Inc ARQT announced topline results from the ARRECTOR Pivotal Phase 3 trial of roflumilast foam 0.3% for treating adults and adolescents with scalp and body psoriasis. 
  • The study met its co-primary endpoints of Scalp-Investigator Global Assessment (S-IGA) Success, Body-Investigator Global Assessment (B-IGA) Success, and all secondary endpoints.
  • About 67.3% of individuals treated with roflumilast foam achieved S-IGA Success compared to 28.1% of individuals treated with a matching vehicle foam at week 8.
  • Related: Atopic Dermatitis Player Arcutis Scoops Up DucentisBioTherapeutics.
  • About 46.5% of individuals treated with roflumilast foam achieved B-IGA Success compared to 20.8% of individuals treated with matching vehicle foam. 
  • Roflumilast foam also demonstrated statistically significant improvements compared to the vehicle on all secondary endpoints, including scalp itch.
  • Roflumilast foam was well-tolerated, and the overall safety and tolerability profile were consistent with previously published studies.
  • The company has already announced plans to submit a marketing application to the FDA for roflumilast foam for seborrheic dermatitis in Q1 of 2023. 
  • Arcutis believes that the results from the ARRECTOR study should provide sufficient bases for a supplemental marketing application.
  • Price Action: ARQT shares are up 4.95% at $19.09 on the last check Monday.
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