Dermavant Sciences have presented successful data from two Phase III trials for tapinarof, for the treatment of psoriasis in adults, PSOARING 1 and PSOARING 2, at the American Academy of Dermatology Virtual Meeting Experience 2021.
Endpoints reported include ≥90% reduction in Psoriasis Area and Severity Index (PASI90) (an endpoint commonly used in assessing systemic agents), itch reduction measured with the Peak Pruritis Numerical Rating Scale, and improvement in quality of life as measured by the Dermatology Life Quality Index.
All secondary endpoints were met with statistically significant results, and patients treated with tapinarof showed significant improvement in all measures of disease activity included in the studies.
Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System, said: “It is encouraging to see Phase III secondary endpoints data like this from a topical. 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.”
PSOARING 1 and PSOARING 2 collectively enrolled 1,025 patients, and were two identically designed, multi-centre, randomised, vehicle-controlled, double-blind, parallel group studies conducted in the US. The studies evaluated the safety and efficacy of tapinarof cream, at 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis.
Psoriasis is a chronic, systemic, inflammatory skin disease characterised by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.
Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions.
Robert Bissonnette, Chief Executive Officer and Medical Director at Innovaderm Research, said: “Psoriasis is a chronic disease that can significantly interfere with all aspects of a patient’s daily life.
“Tapinarof has demonstrated significant promise regarding some of the most problematic symptoms of this skin disease, including significantly reducing itch by at least four points on a 0 to 10 scale.”
Philip M. Brown, MD, Chief Medical Officer at Dermavant, said: “The outcomes of our pivotal Phase III PSOARING trials add to the body of evidence for tapinarof and will be important for patients and the physicians who treat them.
“The consistent, statistically significant, and clinically meaningful improvements in patient-reported outcomes we have seen throughout these trials, support the potential use of tapinarof, if approved, as a topical non-steroidal for psoriasis patients.”
Kat Jenkins
This is a syndicated feed from Pharmafile
