Dermavant announces positive Phase III findings for psoriasis treatment tapinarof
pharmafile | February 19, 2021 | News story | Medical Communications | Dermavant Sciences, psoriasis
Dermavant Sciences has announced positive safety and efficacy results from a planned interim analysis of PSOARING 3, a long-term, open-label safety study of tapinarof in adult patients with plaque psoriasis.
PSOARING 3, along with previously reported PSOARING 1 and PSOARING 2 pivotal efficacy trials, comprise Dermavant’s Phase III programme for the treatment.
Tapinarof is a novel, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA) being developed for the treatment of plaque psoriasis and atopic dermatitis.
While the PSOARING 3 long-term safety study remains ongoing, a pre-planned interim analysis was conducted once at least 100 subjects had received tapinarof cream, 1% for 52 weeks, and a further 300 subjects had received tapinarof cream, 1% for 26 weeks.
Data from the study show that 39.2% of subjects included in the interim analysis achieved complete disease clearance. Additionally, 57.3% of participants with a Physician Global Assessment (PGA) score of 2 or less achieved a PGA score of 0 or 1, indicating tapinarof’s increased therapeutic effect beyond the 12-week double blind treatment periods in PSOARING 1 and 2.
Dr Bruce Strober, Clinical Professor of Dermatology at Yale University School of Medicine and lead investigator for the PSOARING 3 study, said: “The achievement of a PGA score of 0 or 1 by 57.3% of patients following tapinarof treatment is impressive and will be important to patients and prescribers.
“With nearly 40% of patients achieving complete disease clearance, tapinarof has the potential to be an important new topical treatment option for patients suffering from psoriasis.”
Todd Zavodnick, CEO of Dermavant, added: “We are excited to share the results from our interim analysis of PSOARING 3, which represent yet another milestone for Dermavant as we progress towards a mid-2021 NDA submission for tapinarof in adult patients with psoriasis.
“We are now focused on compiling a comprehensive NDA submission highlighting the treatment effect, durability on-therapy, remittive effect off-therapy, safety, and tolerability of tapinarof. At the same time, we are furthering our commercial readiness in anticipation of tapinarof’s potential approval, and advancing the other assets in our development pipeline.”
Darcy Jimenez
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