Phase 3 trials show tapinarof cream, safe effective for plaque psoriasis

August 27, 2020

Dermavant announces positive results from its two identical phase 3 trials investigating tapinarof cream 1% for treatment of plaque psoriasis in adult patients.

Dermavant announced positive results from two phase 3 studies investigating the safety and efficacy of tapinarof cream 1% for treatment of plaque psoriasis in adult patients.

Tapinarof (GSK2894512, Dermavant), a once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA), most recently demonstrated improvement in Psoriasis Area and Severity Index (PASI) as early as week two, an improvement in total target lesion grading scores and a greater reduction from baseline in mean weekly Psoriasis Symptom Diary (PSD) scores in phase 2b studies.

Both the PSOARING 1 and PSOARING 2 are identical phase 3 randomized, double-blind, vehicle-controlled parallel studies in which a combined 1,025 patients were received either tapinarof cream 1% once daily or vehicle once daily in adult patients, ages 18 to 75 years, with plaque psoriasis for 12 weeks. Following the 12-week studies, patients were given the option to participate in an ongoing 52-week safety study, PSOARING 3.

MORE: Tapinarof cream demonstrates positive phase 2b results

The primary endpoints for PSOARING 1 and PSOARING 2 was a proportion of patients who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 12. The secondary endpoint for the studies was the proportion of patients who achieve at least a 75% improvement from baseline according to the Psoriasis Area and Severity Index (PASI 75) at week 12.

Results of the studies show tapinarof met all primary and secondary endpoints, as well as demonstrated a similar safety profile consistent with previous trials.1

“Based on previously published data and my firsthand experience as an investigator, these highly statistically significant phase 3 results point to tapinarof as an effective potential new treatment for psoriasis,” said Mark G. Lebwohl, M.D., dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, and the lead investigator for the PSOARING 1 study. “As a non-steroidal topical cream with the level of efficacy demonstrated in the PSOARING studies, and the potential versatility to be used across mild, moderate, and severe plaque psoriasis, including intertriginous and other sensitive skin areas, I believe tapinarof could become an important treatment for adult patients suffering from this skin disorder.”

In PSOARING 1, 35.4% of patients who received tapinarof 1% (n=340) achieved a PGA score of 0 or 1 at week 12 compared with 6% who were treated with vehicle (n=170). Also, 36.1% of patients in the tapinarof group reached PASI 75 at week 12 vs 10.2% of those in the vehicle group.1

In PSOARING 2, 40.2% of patients who received tapinarof once daily (n=343) achieved a PGA score of 0 or 1 at week 12 vs 6.3% of those treated with vehicle (n=172). Meanwhile, 47.6% of patients treated with tapinarof reached PASI 75 at week 12 compared with 6.9% of those treated with vehicle. The company also reports up to 80% of patients achieved a ≥1-grade improvement in PGA throughout both studies.1

RELATED: Patient enrollment completed for Dermavant phase 3 psoriasis clinical trials

The most common adverse events (AE) reported during the studies include nasopharyngitis, contact dermatitis and folliculitis, which were observed primarily at application site. No serious drug-related AEs were reported in either of the studies, according to the company.1

“The PSOARING 1 and PSOARING 2 results support our belief that, subject to FDA approval, tapinarof cream could become a highly beneficial treatment option for adult patients living with mild, moderate and severe plaque psoriasis,” said Philip Brown, M.D., JD, chief medical officer of Dermavant. “With minimal systemic drug exposure, these data point to the potential use of tapinarof as a novel topical non-steroidal, capable of being used in sensitive and difficult to treat areas of the body such as face, groin and under arms. As such, we are excited by the efficacy and safety results of tapinarof exhibited across multiple trials.”

Dermavant plans to submit full results of the studies to peer-reviewed medical journals and present the data at future medical congresses.1

“Plaque psoriasis remains a chronic disease for millions of patients globally, and can result in a profound burden on a patient’s quality of life if not adequately controlled,” said Linda Stein Gold, M.D., director of dermatology clinical research at Henry Ford Health System, Detroit, and lead investigator for the PSOARING 2 study. “Based on these phase 3 trial results and subject to FDA approval, tapinarof could offer healthcare providers and patients a highly efficacious, well tolerated, non-steroidal first line treatment for psoriasis in a cosmetically elegant cream — long an aspiration for dermatologists.”

References:

1. Dermavant Reports Positive Phase 3 Results for Tapinarof Cream in Adult Patients with Plaque Psoriasis. (2020, August 26). Retrieved August 26, 2020, from https://www.businesswire.com/news/home/20200826005389/en/Dermavant-Reports-Positive-Phase-3-Results-Tapinarof