RARE Daily

Incyte Reports Positive Data from Phase 2 Study in Rare Skin Disease

March 11, 2024

Rare Daily Staff

Incyte reported results that its phase 2 study evaluating the efficacy and safety of povorcitinib, an oral JAK1 inhibitor, in adult patients with prurigo nodularis met its primary and secondary endpoints.

Prurigo nodularis (PN) is a rare, chronic inflammatory skin disease characterized by intense itch and thickened red bumps on the arms, legs and trunk. Due to the result of persistent, intense scratching and rubbing of the skin, PN results in itchy bumps on the skin called “nodules.” PN appears to be more common in older individuals, and the painful bumps and constant itch can have a substantial impact on a patient’s sleep and overall quality of life.

The phase 2 study, a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of povorcitinib in 146 adult patients with prurigo nodularis, 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 percent, 44.4 percent, 54.1 percent for 15, 45, 75 mg, respectively) than those who received placebo (8.1 percent) 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.

The data were presented as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting in San Diego.

“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, 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.”

The secondary endpoints of the study were also met. At Week 16, 13.9 percent, 30.6 percent and 48.6 percent 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 percent of patients who received placebo. Further, 8.3 percent, 22.2 percent and 35.1 percent 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 percent 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, fatigue, and nasopharyngitis.

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