Incyte (NASDAQ: INCY) announced 54-week data from its Phase 3 STOP-HS clinical trial program evaluating povorcitinib for moderate to severe hidradenitis suppurativa (HS). The data was presented at the American Academy of Dermatology Annual Meeting in Denver.

Through Week 54, up to 71.4% of patients achieved HiSCR50, defined as at least a 50% reduction in abscess and inflammatory nodule count without an increase in abscess or draining tunnel count. Up to 57% of participants achieved HiSCR75 and up to 29% achieved HiSCR100.

Povorcitinib treatment led to reductions across inflammatory lesion types, with full resolution achieved in up to 20% of patients. The drug also showed improvements in quality-of-life measures, including skin pain and fatigue, at Week 54.

The safety profile through 54 weeks remained consistent with previously reported data. Treatment-emergent adverse events occurred in 76.2% to 83.4% of patients, with most events reported as mild or moderate. The most frequent adverse events were acne, nasopharyngitis and upper respiratory tract infections.

Serious treatment-emergent adverse events occurred in 3.7% to 6.4% of patients. Adverse events leading to discontinuation occurred in 6.1% to 9.4% of patients. Rates of adverse events of special interest, including herpes zoster and serious infections, were low at less than 2.3%.

The STOP-HS program includes two Phase 3 studies that enrolled approximately 600 patients each. Both studies met their primary endpoint at Week 12, showing statistical significance versus placebo for both 45 mg and 75 mg doses of povorcitinib.

Incyte has submitted a New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for povorcitinib as a treatment for HS, both of which are under review.