Tapinarof

Published

dm+d

Unassigned

New Medicines

Plaque psoriasis in adults

Information

New molecular entity
Dermavant Sciences GmbH
Dermavant Sciences GmbH

Development and Regulatory status

None
None
Approved (Licensed)
May 22FDA approves Vtama for use in adults with plaque psoriasis. Vtama ’s label covers the full spectrum of disease - mild, moderate and severe. Dermavant is planning a June launch, having completed product and sample manufacturing runs, and prepared its commercial operations [9].
May 21Filed in US [6].
Feb 21Dermavant expects to complete open-label extension study in the first half of 2021 and plans to file in the US by mid 2021[5].
Aug 20NDA expected to be filed with FDA in 2021 [2].

Category

Aryl hydrocarbon receptor agonist , applied once-daily
Psoriasis affects about 1.3 to 2.2% of people in the UK, with 90% of cases being plaque psoriasis. Highest prevalence in white people [1].
Plaque psoriasis in adults
Topical

Trial or other data

Dec 21Results of PIII PSOARING 1 and PSOARING 2 RCTs (n=510; n=515) reported in NEJM [8].
Sep 21Dermavant present final results of PIII PSOARING-3 trial at conference. Study of patients receiving treatment for up to 52 weeks (n=763) found tapinarof 1% cream was associated with continued improvement in efficacy beyond 12 weeks, with 40.9% achieving complete disease clearance (PGA score 0), with durability of response demonstrated [7].
Aug 21Following the 12-week, vehicle-controlled portion of PSOARING 1 and PSOARING 2, patients have the option to enroll in PSOARING 3 (NCT04053387), a long term, open-label extension study for an additional 40 weeks of treatment. Over 90% of eligible patients who completed PSOARING 1 and PSOARING 2 have enrolled PSOARING 3, the estimated primary completion date of which is November 2020 [3,4].
Feb 21Interim analysis of data from 100 patients in the open-label extension study PSOARING 3 (NCT04053387) who have completed 52 weeks of treatment, along with data from the original 12 weeks trials, and a further 300 patients who have completed 26 weeks of treatment has shown 57% of patients had PGA scores of zero or one and had experienced a two-grade or greater improvement. Almost 40% of patients had scores of zero, indicating that their skin was clear [5].
Oct 20Dermavant reports that the Primary Endpoints were met in PIII PSOARING 1 (n=510) and PSOARING 2 (n=515) trials. At week 12, 35.4% and 40.2% of patients treated with tapinarof cream in PSOARING 1 and PSOARING 2 respectively achieved the primary endpoint of a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement compared to 6.0% and 6.3% of patients treated with vehicle (p<0.0001 and p<0.0001) [3].
Aug 20Initial results from two PIII trials, PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), have been released, demonstrating superiority of tapinarof cream versus inactive cream. The primary efficacy endpoint (clear or almost clear skin with minimum 2 point improvement on the five point Physician Global Assessment at 12 weeks) was achieved by 35% of patients in PSOARING 1 and 40% of patients in PSOARING 2, compared to approximately 6% of placebo patients in both trials. The key secondary endpoint of PASI-75 was achieved by 36% (PSOARING 1) and 48% (PSOARING 2) of tapinarof patients compared to 10% and 7% of placebo patients respectively. Side effects are reported to be mostly mild to moderate, affecting areas of skin that come into contact with cream. Folliculitis, rash, and nasopharyngitis were the most common adverse effects. Less than 6% of tapinarof patients left the study due to adverse effects [2].