Roivant Reports Positive Topline Results from ADORING 1, the Second Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old
Roivant Sciences Ltd. (ROIV)
Company Research
Source: GlobeNewswire
ADORING 1 met the primary and all secondary endpoints, consistent with the positive topline results from the Phase 3 ADORING 2 trial reported in March, marking Roivant’s 10th consecutive positive Phase 3 study since 201945.4% of subjects receiving VTAMA achieved the primary endpoint of vIGA-AD™ response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 13.9% on vehicle (PAll secondary endpoints were met with statistical significance, including 55.8% of subjects treated with VTAMA who achieved the key secondary endpoint of EASI75 at Week 8 (PMeaningful impact on the exploratory endpoint of pruritus (itch) was demonstrated with 61.1% of subjects, with a baseline PP-NRS score =4, achieving a =4-point reduction in the PP-NRS at Week 8 (P91% of subjects from ADORING 1 & 2 elected to enroll into the Phase 3 ADORING 3 open-label, long-term safety study*sNDA for VTAMA in atopic dermatitis anticipated to be filed with the FDA in Q1 2024
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ROIV
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- 2/13/24 - Beat
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