Incyte Announces Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo

Incyte has 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 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<0.01). Additionally, more patients who received povorcitinib achieved the key secondary endpoint of T-VASI50 (≥50% reduction from baseline in the T-VASI) at Week 24 (10.5%, 15 mg arm; 15.2%, 45 mg arm; 5.6%, 75 mg arm vs. 3.0%, placebo arm) and continued to improve during an open-label extension period through Week 36 of treatment (28.6%, povorcitinib 15 → 75 mg arm; 17.2%, 45 mg arm; 15.2%, 75 mg arm; and 3.0%, placebo → 75 mg arm), following dose adjustment.

“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.”

“Vitiligo is a chronic autoimmune condition that can be difficult to manage, particularly for patients with extensive disease that manifests across a significant portion of their body,” said Amit G. Pandya, M.D., Staff Dermatologist, Department of Dermatology, Palo Alto Foundation Medical Group and Adjunct Professor, Department of Dermatology, University of Texas Southwestern Medical Center. “As vitiligo can impact patients in different ways, I am encouraged by the continued focus on expanding medical treatment options, and I believe these data highlight the potential of this investigational oral treatment for patients with extensive nonsegmental vitiligo.”