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.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareSmall CapMoversTrading IdeasGeneralBriefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!