Tapinarof for psoriasis phase 3 data

[Fred]

Dermavant to Showcase PASI90, Itch and Quality of Life Data from Phase 3 Pivotal Trials for Tapinarof

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Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data from its two pivotal Phase 3 trials for tapinarof for the treatment of psoriasis in adults, PSOARING 1 (tapinarof 1%, n=340; vehicle, n=170) and PSOARING 2 (tapinarof 1%, n=343; vehicle, n=172), at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021) on April 23-25, 2021.

The posters feature important secondary efficacy endpoints and patient-reported outcomes data from patients with mild, moderate, or severe chronic plaque psoriasis after 12 weeks of treatment with tapinarof cream 1% dosed once daily (QD) compared to vehicle QD.

Endpoints reported include ≥90% reduction in Psoriasis Area and Severity Index (PASI90) (an endpoint more commonly used in assessing systemic agents), itch reduction measured with the Peak Pruritis Numerical Rating Scale (PP-NRS), and improvement in quality of life as measured by the Dermatology Life Quality Index (DLQI). All secondary endpoints were met with highly statistically significant results, and patients treated with tapinarof showed significant improvement in all measures of disease activity included in the studies.

Highlights from Secondary Efficacy Endpoints and Patient-Reported Outcomes:

• PASI90 – At Week 12, a significantly higher proportion of patients treated with tapinarof cream 1%, QD achieved PASI90 in PSOARING 1 (18.8%) and PSOARING 2 (20.9%) compared to patients treated with vehicle in PSOARING 1 (1.6%; P=0.0005) and PSOARING 2 (2.5%; P<0.0001).
  

• ≥4-point Improvement in PP-NRS – Peak Pruritis-NRS – A statistically significant higher proportion of patients treated with tapinarof cream 1%, QD achieved at least a 4-point NRS improvement – a change that is considered clinically meaningful – at each time point from Week 2 through Week 12. At Week 12 in PSOARING 1 and PSOARING 2 that proportion was 67.5% and 59.7% respectively, compared to patients treated with vehicle (46.1% in PSOARING 1; P=0.0004, and 31.3% in PSOARING 2; P<0.0001).
  

• DLQI – At Week 4, patients treated with tapinarof cream, 1% QD reported significant improvements in quality of life as measured by the DLQI. A minimal clinically important difference of –4.0 in DLQI was exceeded at Week 12 for patients treated with tapinarof (–5.0 in PSOARING 1; –4.7 in PSOARING 2). These reductions were significant (both P<0.0001) compared to vehicle (–3.0 in PSOARING 1; –1.6 in PSOARING 2).
  

“It is encouraging to see Phase 3 secondary endpoints data like this from a topical,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System. “Seeing the PASI90 scores for approximately one in five patients in the PSOARING pivotal trials makes me extremely excited for what tapinarof may mean as a treatment option for patients with psoriasis, if approved.”

Source: dermavant.com