Phase 2B clinical trial results demonstrate that patients experienced improvement in total body and facial repigmentation.
Incyte announced new data from a phase 2b clinical trial, which evaluated the efficacy and safety of povorcitinib (INCB54707) in adults with extensive nonsegmental vitiligo.
Povorcitinib, an investigational oral JAK1 inhibitor, was associated with substantial total body re-pigmentation in individuals with extensive nonsegmental vitiligo, measured by total Vitiligo Area Scoring Index (T-VASI).
“Vitiligo is a chronic, immune-mediated disease which, until recently, had limited treatment options available to patients. We are proud to have brought to market the first and only [FDA]-approved pharmacologic therapy for vitiligo and continue to develop additional treatments for patients with vitiligo,” Kurt Brown, MD, associate vice president of drug development in inflammation and autoimmunity and global program head of povorcitinib at Incyte, said in a statement.
“These data suggest the potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo and its potential versatility across multiple autoimmune and inflammatory conditions, including hidradenitis suppurativa for which we recently announced 52-week phase 2 results,” he said.
Investigators included171 individuals aged 18 to 75 years who had nonsegmental vitiligo that affected 8% or more of their body surface area.
The study met its primary endpoint, with individuals receiving povorcitinib experiencing statistically superior improvements in T-VASI at week 24 compared with the placebo.
Additionally, more individuals who received povorcitinib achieved the key secondary endpoint of T-VASI50 at week 24, continuing to improve during an open-label extension period through week 36 following dose adjustment.
The treatment with povorcitinib also resulted in facial re-pigmentation in individuals with extensive nonsegmental vitiligo, which was measured by facial Vitiligo Area Scoring Index (F-VASI) scores. At week 24, individuals on povorcitinib experienced statistically superior improvements in F-VASI compared with the placebo.
Approximately 18.4%, 44.5%, and 27.8% of individuals treated with povorcitinib in the 15-, 45-, and 75-mg strengths, respectively, achieved 50% or greater reduction from the baseline in F-VASI compared with 9.1% in the placebo group.
Additionally, 13.2%, 18.2%, and 13.9% of individuals with the same dosage strengths, respectively, treated with povorcitinib achieved a 75% or greater reduction from baseline in F-VASI compared with 3.0% in the placebo group.
Investigators found continued improvement of total body and facial re-pigmentation with povorcitinib through 36 weeks.
At week 36, T-VASI/F-VASO scores were -30.3%/-38.4% with povorcitinib in the 15-to-75-mg strengths, with -28.4%/51.1% in the 45-mg arm, with -28.8%/-54.3% in the 75-mg arm, and5.3%/-26.1% in the placebo to the 75-mg arm.
Investigators found that povorcitinib was generally well tolerated, with the most common treatment-emergent adverse events (TEAEs) during the 24-week, placebo-controlled period, including acne, blood creatine phosphokinase increased, COVID-19, fatigue, and headache.
There were no serious TEAEs related to povorcitinib treatment, and there were no new safety signals observed after week 24.
The data were presented in a late-breaking oral presentation at the 2023 American Academy of Dermatology Annual Meeting in New Orleans that took place between March 17 and 21.
Incyte announces data from phase 2b study evaluating povorcitinib (INCB54707) in patients with extensive nonsegmental vitiligo. Incyte. News release. March 18, 2023. Accessed March 20, 2023. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-data-phase-2b-study-evaluating-povorcitinib