Dermavant's Tapinarof Shows Durable Improvement in PsO in Long-term Extension Study

March 27, 2022
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Results from the Phase 3 PSOARING 3 long-term extension study demonstrate durable improvements across efficacy outcomes, quality of life measures, and tolerability scores with investigational tapinarof cream 1% once daily (QD) for the treatment of plaque psoriasis in adults. The data, from prespecified endpoints of the Phase 3 PSOARING 3 long-term extension study, were presented at the 2022 AmericanAcademy of Dermatology (AAD) Annual Meeting.

Eligible patients who completed either PSOARING 1 or 2, the 12-week pivotal studies of Dermavant’s tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3. PSOARING 3 consisted of an additional 40 weeks of open-label intermittent treatment with tapinarof based on Physician Global Assessment (PGA)score, followed by a 4-week follow-up. Patients who were randomized to tapinarof in PSOARING 1 or 2 and who also completed PSOARING 3 received tapinarof treatment for up to 52 weeks.

Continued improvements were observed in all assessments beyond the responses observed in the 12-weekpivotal studies. Investigators rated the majority of patients as having no irritation (score of 0), including thosewho applied tapinarof to sensitive skin and intertriginous areas at all time points across 40 weeks.

Long-term treatment with tapinarof cream 1% QD for up to 52 weeks demonstrated continued and durable improvement in mean PASI score, PASI75, PASI90, %BSA Affected, DLQI, and local tolerability scores.

“Plaque psoriasis is often a lifelong condition that can have a significant negative impact on many aspects ofa patient’s life. Due to limitations in current psoriasis therapies, there is a strong need for new topicaltreatments for adults suffering with this condition,” says April W. Armstrong, MD, MPH, a dermatologist with Keck Medicine of USC and Professor of Dermatology and Associate Dean for Clinical Research in Dermatology at the Keck School of Medicine of USC. “The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging. As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering fromplaque psoriasis.”

“We are pleased to report data demonstrating continued improvements in efficacy and patient reported outcomes with use of tapinarof cream 1% once daily, beyond 12 weeks in adults with plaque psoriasis,” says  Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant. “These data reinforce the potential tapinarofholds as a possible new treatment option for adults with mild, moderate and severe plaque psoriasis, subject toFDA approval.”

FDA accepted a New Drug Application in August for tapinarof cream 1% for the treatment of plaque psoriasis in adult patients. A Prescription Drug User Fee Act target action date has been assigned in Q2 2022. If approved, tapinarof will be a potential first-in-class, novel small-molecule therapeutic aryl hydrocarbon receptor (“AhR”) modulating agent for adults with plaque psoriasis.

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