Incyte(INCY) ZACKS·2025-03-10 15:56Core Insights - Incyte announced positive results from two late-stage studies for ruxolitinib cream 1.5% in treating prurigo nodularis (PN) [1][10] - The TRuE-PN1 study achieved its primary endpoint, showing significant improvement in itch relief compared to vehicle control [5][7] - The TRuE-PN2 study showed a positive trend across key secondary endpoints, although the primary endpoint did not reach statistical significance [9][10] Company Overview - Ruxolitinib cream 1.5% is a topical JAK1/2 inhibitor, currently approved for nonsegmental vitiligo and mild to moderate atopic dermatitis in the U.S. [3] - The cream is indicated for a chronic inflammatory skin condition affecting approximately 200,000 people in the U.S., primarily those aged 40-69 [2] Study Results - In the TRuE-PN1 study, 44.6% of patients using Opzelura experienced a ≥4-point improvement in the Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 compared to 20.6% in the control group [5] - Significant itch relief was observed as early as Day 7, with 22.4% of patients achieving relief compared to 8% in the control group [6] - The study met all key secondary endpoints, with 15.8% of Opzelura patients achieving treatment success on the Investigator's Global Assessment for Stage of Chronic Prurigo (IGA-CPG-S-TS) compared to 3.9% in the control group [7] Safety Profile - Opzelura was generally safe and well-tolerated in both studies, with no new safety signals observed [10] - The safety profile was consistent with previous data, indicating a favorable risk-benefit ratio for patients [10] Future Steps - Results from the TRuE-PN1 and TRuE-PN2 studies will guide discussions with regulatory authorities regarding next steps for Opzelura [11]