— 80.7% (574/711) of patients achieved EASI75 (at least a 75% reduction in disease burden) in an integrated analysis of all the ADORING Program studies — — 77.9% (218/280) of patients ≥12 years old with a baseline PP-NRS (itch) score ≥4 achieved a ≥4-point reduction in PP-NRS. In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application — — 73% (519/711) of patients included in the integrated analysis achieved a vIGA-ADTM score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline — — 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0) in an interim analysis of the ADORING 3 open-label, long-term extension study— — No new safety signals were observed with up to 56 weeks of treatment — — Data from these analyses will be included in the sNDA submission for VTAMA cream, 1% expected in Q1 2024 — LONG BEACH, Calif., and BASEL, Switzerland, January 11, 2024 –
https://www.organon.com/news/dermavant-issued-release-dermavant-announces-positive-data-from-the-adoring-phase-3-development-program-in-atopic-dermatitis-with-vtama-tapinarof-cream-1-in-adults-and-children-as-young-as/
— 88.5% of adult patients achieved a target lesion Physician Global Assessment (tPGA) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at Week 12 (tPGA Success), reinforcing strong efficacy in these areas — — 80.8% of adult patients achieved tPGA score of 0 (clear) at Week 12, indicating complete clearance of the target plaque psoriasis lesion in the head and neck region — — 96.2% of patients achieved ≥ 75% improvement in Psoriasis Area and Severity Index (PASI75) of the head and neck region at Week 12 — — 70% of the adult patients achieved the widely followed standard of improvement in itch as measured by the Peak Pruritis-Numeric Rating Scale (PP-NRS) (head and neck region) of ≥ 4 points at Week 12, with some patients achieving this meaningful reduction in itch as early as Week 1 — — 96.7% of patients strongly agreed or agreed that VTAMA cream quickly absorbs and 93.3% of subjects strongly agreed or agreed that VTAMA cream was not greasy,
https://www.organon.com/news/dermavant-issued-release-dermavant-announces-positive-results-from-phase-4-open-label-trial-of-vtama-tapinarof-cream-1-for-the-treatment-of-plaque-psoriasis-in-the-head-and-neck-region-in-a/
– 45.4% of subjects receiving VTAMA achieved the primary endpoint of vIGA-ADTM 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 (P<0.0001) – – All 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 (P<0.0001) – – Meaningful 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 (P<0.0001) – – 91% of subjects from ADORING 1 & 2 elected to enroll into the Phase 3 ADORING 3 open-label, long-term safety study* – – ADORING 1 met the primary and all key secondary endpoints, consistent with the positive topline results from the Phase 3 ADORING 2 trial reported in March – – sNDA for VTAMA in atopic dermatitis anticipated to be filed with the FDA in Q1
https://www.organon.com/news/dermavant-issued-release-dermavant-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/
– 46.4% of subjects receiving VTAMA cream, 1% achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 18.0% on vehicle (P<0.0001) – – All secondary endpoints were met with a high degree of statistical significance, including 59.1% of subjects treated with VTAMA cream who achieved the key secondary endpoint of EASI75 (P<0.0001) – – Meaningful impact on the key secondary endpoint of pruritus (itch) was demonstrated with 52.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieving a ≥4-point reduction in the PP-NRS at Week 8 (P=0.0015) – – Rollover rate of 92.4% of Phase 3 subjects from this trial into the open-label, long-term safety study* – – Conference call and webcast on March 15, 2023 at 8:00 a.m. ET – LONG BEACH, Calif., and BASEL, Switzerland, March 15, 2023 – Dermavant Sciences, a
https://www.organon.com/news/dermavant-issued-release-dermavant-reports-positive-topline-results-from-adoring-2-atopic-dermatitis-phase-3-trial-of-vtama-tapinarof-cream-1-once-daily-in-adults-and-children-as-young-as-2/
– Study demonstrated minimal-to-no systemic exposure despite maximal use – – Subjects were as young as 2 years old with up to 90% body surface area (BSA) affected and a mean BSA of 43% – – Maximal usage study utilized same dose of VTAMA cream, 1% currently FDA-approved for adult plaque psoriasis – LONG BEACH, Calif., and BASEL, Switzerland, November 8, 2022 —Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its maximal usage study of VTAMA ® (tapinarof) cream, 1% in children down to age 2 years old with extensive burden of atopic dermatitis. “We are delighted with the results from our maximal usage study of VTAMA cream, 1% in atopic dermatitis, which for the first time demonstrated highly favorable safety, pharmacokinetics, and clinical improvement in pediatric patients as young as two years of age,” said Philip M. Brown, MD, JD, Chief Medical Officer of
https://www.organon.com/news/dermavant-issued-release-dermavant-announces-highly-favorable-results-from-pediatric-maximal-usage-study-of-vtama-tapinarof-cream-1-in-atopic-dermatitis/
– EFFICACY: In the pivotal Phase 3 clinical trial program, VTAMA cream met all primary and secondary endpoints and demonstrated highly statistically significant improvement versus vehicle in Physician Global Assessment (PGA) score with 36% of patients versus 6% in vehicle in PSOARING 1 and 40% of patients versus 6% in vehicle in PSOARING 2 achieving clear or almost clear with a minimum 2-grade improvement at week 12 (p<0.0001 for both trials) – – REMITTIVE EFFECT: The median duration of clear or almost clear skin was approximately four months after cessation of treatment with VTAMA cream as measured by the time to first worsening while off-therapy during the Phase 3 Long Term Extension (LTE) study for patients who achieved clear skin (PGA 0) on VTAMA cream during PSOARING 1 or 2 – – DURABILITY: Durability of response up to 52 weeks was demonstrated with intermittent use of VTAMA cream, with no observation of tachyphylaxis (loss of response) while on therapy – – SAFE AND
https://www.organon.com/news/dermavant-issued-release-fda-approves-dermavants-vtama-tapinarof-cream-1-for-the-treatment-of-plaque-psoriasis-in-adults-first-topical-novel-chemical-entity-launched-for-psoriasis/