Incyte Releases Mixed Data From Late-Stage Opzelura Studies In Skin Disease Characterized By Itchy Firm Lumps

On Saturday, Incyte Corporation INCY revealed results from its pivotal Phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura) in adult patients with prurigo nodularis (PN), a chronic skin condition characterized by very itchy firm lumps.

The data were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

Also Read: Incyte Q4 Earnings: EPS Miss, Strong Jakafi And Opzelura Sales, Says 2025 To Be Catalyst Rich Including 4 Launches

The TRuE-PN1 study met its primary endpoint, demonstrating that significantly more PN patients who applied ruxolitinib cream 1.5% versus vehicle control achieved a ≥4-point improvement from baseline in Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 (44.6% vs 20.6%).

Significant itch improvements were observed with ruxolitinib cream 1.5% versus vehicle control at Day 7 (22.4% vs. 8.0%), with numerical improvements versus vehicle control reported at earlier timepoints. Additionally, the TRuE-PN1 study met all key secondary endpoints, including:

• Significantly more patients who applied ruxolitinib cream 1.5% versus vehicle control achieved an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS) at Week 12 (15.8% vs 3.9%).
• Significantly more patients who applied ruxolitinib cream 1.5% versus vehicle control achieved overall treatment success (11.9% vs 2.9%).
• Significantly more patients treated with ruxolitinib cream 1.5% versus vehicle control also achieved WI-NRS4 at Week 4 (29.7% vs 12.7%).

Additionally, topline data from the Phase 3 TRuE-PN2 clinical trial demonstrated a positive trend across all key secondary endpoints at Day 7 (nominal P-value <0.05 for both).

While the primary endpoint favored ruxolitinib cream 1.5% versus vehicle, it did not reach statistical significance due to the high placebo response.

William Blair analyst Matt Phipps sees the TRuE-PN study results as disappointing, but they don't impact Incyte valuation since the model didn't factor in Opzelura's potential for PN. The company considers PN a smaller market for Opzelura, generating less than $1 billion, compared to its use for atopic dermatitis and vitiligo.

Price Action: INCY stock is up 0.92% at $71.44 at the last check Monday.

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