The company plans to file an sNDA for VTAMA cream in AD in Q1 2024.

Dermavant’s VTAMA (tapinarof) Cream, 1% reduces pruritus in adults and kids with atopic dermatitis as early as 24 hours after the first application, according to new data from ADORING 1 and ADORING 2 presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin.

The company plans to file a supplemental new drug application (sNDA) for VTAMA cream in atopic dermatitis with the U.S. Food and Drug Administration in Q1 2024.

In ADORING 1 (N=407) and ADORING 2 (N=406), two identical, double-blind, vehicle-controlled trials, patients were randomized 2:1 to tapinarof cream 1% QD or vehicle QD for 8 weeks. Patients with a Validated Investigator Global Assessment for Atopic DermatitisTM (vIGA-ADTM) score of ≥3, an Eczema Area, and Severity Index (EASI) score of ≥6, and body surface area involvement of 5%-35% were included. The efficacy endpoints that evaluated itch relief included mean changes in Peak Pruritus-Numeric Rating Scale (PP-NRS) score (daily and by visit [Weeks 1, 2, 4, and 8]) from baseline through Week 8. The PP-NRS considers a person’s worst itch over the past 24 hours, assessed on an 11-point scale (0 indicates “no itch” and 10 indicates “worst imaginable itch”).

The new data comprises daily recorded PP-NRS scores of patients in ADORING 1 and ADORING 2 on VTAMA cream for the first time. Daily PP-NRS scores were recorded in patient diaries. Patients aged ≥12 years old self-completed the PP-NRS, while caregivers completed it for children aged <12 years old. At baseline, the mean overall PP-NRS scores were 6.7 and 6.8 in ADORING 1 and ADORING 2, respectively.

The studies found:

• Greater reductions in mean daily PP-NRS scores for tapinarof versus vehicle were observed as early as Day 1, 24 hours after initial application, in ADORING 1 and Day 2 in ADORING 2.
• Improvements in daily PP-NRS scores with tapinarof versus vehicle continued through the first 2 weeks and through Week 8 of both trials.
• Highly statistically significant and clinically meaningful reductions in mean weekly PP-NRS scores as early as Week 1, the first assessment, for patients treated with tapinarof compared with vehicle in ADORING 1 and ADORING 2, respectively.
• Greater reductions in mean PP-NRS scores with tapinarof versus vehicle were seen for all visits through Week 8 in both ADORING 1 and ADORING 2.

“Itch remains the most burdensome symptom of atopic dermatitis, negatively impacting the quality of life of not only the patients but also their families,” says Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of CLEAR Eczema Center, at the Oregon Health & Science University, in a news release. “Today’s new pruritus data, combined with the initial Phase 3 data, suggest that if approved, VTAMA cream has the potential to change the treatment paradigm for adults and children being treated for atopic dermatitis through disease control and symptom reduction capabilities.”

“The new pruritus data presented today at the EADV Congress is extremely encouraging, as it highlights VTAMA cream’s ability to reduce itch, the most prevalent symptom of atopic dermatitis, as early as 24 hours after the first application in some adults and children as young as 2 years old,” adds Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “We are truly excited about VTAMA cream’s potential and remain committed to bringing this steroid-free, topical treatment to the forefront as an option for the millions of patients suffering from atopic dermatitis.”