Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis

Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN). These data were presented as a late-breaking oral presentation (Session: S050 – Late-Breaking Research: Session 2) at the American Academy of Dermatology (AAD) Annual Meeting, held from March 8-12, 2024, in San Diego.

The study met its primary endpoint with a ≥4-point improvement in itch Numerical Rating Scale (NRS4) score achieved by significantly more patients who received povorcitinib across all dosing groups (36.1% [P<0.01], 44.4% [P<0.001], 54.1% [P<0.0001] for 15, 45, 75 mg, respectively) than those who received placebo (8.1%) at Week 16. Median times to itch NRS4 were 58, 35 and 17 days for patients who received 15, 45 and 75 mg of povorcitinib, respectively, and was not estimable for the placebo arm.

“PN is a condition that can cause itchy bumps on the skin called nodules, which appear after excessive scratching. Despite the severity of the disease and the significant impact it can have on a patient’s day-to-day life, there remains a significant need for effective treatments,” said Kurt Brown, M.D., Vice President and povorcitinib Global Program Head, Incyte. “These Phase 2 results, particularly the demonstrated improvement in itch resolution after just four weeks of treatment, are promising for patients around the world living with this disease. We are excited to be expanding research on povorcitinib into this new potential indication.”

The secondary endpoints of the study were also met. At Week 16, 13.9%, 30.6% and 48.6% of patients who received 15, 45 and 75 mg of povorcitinib, respectively, achieved an Investigator’s Global Assessment Treatment Success (IGA-TS) score of 0 or 1 with a ≥2-grade improvement from baseline, versus 5.4% of patients who received placebo. Further, 8.3%, 22.2% and 35.1% of patients who received 15, 45 and 75 mg of povorcitinib, respectively, achieved both itch NRS4 and IGA-TS at Week 16, versus 2.5% of patients who received placebo.

Povorcitinib was generally well-tolerated, and the safety profile was consistent with previously reported data. The most common treatment-emergent adverse events (TEAEs) among patients who received povorcitinib were headache (11.1%), fatigue (9.3%) and nasopharyngitis (7.4%). Grade ≥3 TEAEs and serious TEAEs occurred in four (3.7%) and nine (8.3%) povorcitinib-treated patients, respectively, and discontinuations due to AEs were infrequent (povorcitinib, n=5 [4.6%]; placebo, n=1 [2.7%]).