Phase 3 PSOARING 3 Long-Term Extension Study Data Positive for Tapinarof Cream

June 28, 2022

New data from the one-year safety and efficacy final analyses of the Phase 3 PSOARING 3 long-term, open-label extension (“LTE”) study of Dermavant Sciences' VTAMA (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults was published in the Journal of the American Academy of Dermatology (JAAD) on June 26, 2022. 

"We are excited that a journal as prestigious as JAAD has chosen to publish final data from our PSOARING 3 40-week extension efficacy and safety study of VTAMA® (tapinarof) cream, 1% for adults with plaque psoriasis," says Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant, in a news release. “We were delighted by the FDA’s recent approval of VTAMA cream for mild, moderate, and severe disease, which we believe can become an improved standard of care for plaque psoriasis patients and their healthcare providers. VTAMA cream’s demonstrated combination of efficacy, remittive effect, durability and tolerability make it a strong addition to the psoriasis armamentarium.” 

Newly published final data in JAAD includes efficacy outcomes, quality of life, safety, and tolerability assessments observed over long-term use of VTAMA (tapinarof) cream, 1%. The PSOARING 3 LTE study forms part of Dermavant’s pivotal Phase 3 plaque psoriasis clinical program for VTAMA cream. Treatment was based on Physician Global Assessment (PGA) score. Patients entering with PGA≥1 received VTAMA cream until reaching PGA=0. Efficacy outcomes in the additional 40-weeks of the LTE study illustrate continued improvement beyond the 12-week double blind treatment period in the pivotal studies (PSOARING 1 and 2) with up to 41% of patients (n=312/763) ultimately achieving complete disease clearance (PGA=0). In addition, once complete disease clearance was achieved in the LTE study and patients discontinued using VTAMA cream (n=312), the mean total duration off therapy before disease worsening (defined as PGA≥2) was 130 days.  Patients with PGA≥2 were re-treated with VTAMA cream until reaching PGA=0.  Importantly, there was no evidence of loss of effect while on therapy, illustrating a durable response. Lastly, there were no new safety or tolerability signals observed over long-term use, even in sensitive anatomic locations. The most frequent adverse events in the LTE study were folliculitis, contact dermatitis and upper respiratory tract infection. 

On May 24, FDA approved VTAMA (tapinarof) cream, 1% for the treatment of adult plaque psoriasis. The approval made VTAMA cream the first topical novel chemical entity launched for psoriasis in the U.S. in 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis with no label restrictions on duration of use or body surface area.

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