Incyte (INCY) Reports Data from Phase 2b Study of Povorcitinib
Incyte (Nasdaq: NASDAQ:) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. These data were presented today in a late-breaking oral presentation (Session: S042 – Late-Breaking Research: Session 2) at the 2023 American Academy of Dermatology (AAD) Annual Meeting, held from March 17-21 in New Orleans.
Results from the study demonstrate that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients with extensive nonsegmental vitiligo, as measured by total Vitiligo Area Scoring Index (T-VASI) scores. Specifically, the study met its primary endpoint and patients receiving povorcitinib experienced statistically superior improvements in T-VASI at Week 24 compared to placebo (povorcitinib 15 mg, –19.1%; 45 mg, –17.8%; 75 mg, –15.7% vs. placebo, +2.3%; least squares mean [LSM] difference, P
“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 U.S. Food and Drug Administration (FDA) approved pharmacologic therapy for vitiligo, and continue to develop additional treatments for patients with vitiligo,” said Kurt Brown, M.D., Global Program Head, Povorcitinib, and Associate Vice President, Drug Development, Inflammation & Autoimmunity, Incyte. “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.”
Additional key findings from the study include:
- Treatment with povorcitinib also resulted in facial repigmentation in patients with extensive nonsegmental vitiligo, as measured by facial Vitiligo Area Scoring Index (F-VASI) scores. At Week 24, patients receiving povorcitinib experienced statistically superior improvements in F-VASI compared to placebo (15 mg, –27.7%; 45 mg, –36.4%; 75 mg, –29.4% vs. placebo, –5.1%; LSM difference, P
- At Week 24, 18.4% (15 mg), 45.5% (45 mg) and 27.8% (75 mg) of patients treated with povorcitinib achieved ≥50% reduction from baseline in F-VASI (F-VASI50) compared to 9.1% in…