Incyte announces new data from STOP-HS clinical trial program at EADV

Incyte (INCY) announced new 24-week interim data evaluating the safety and efficacy of povorcitinib, an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients with moderate to severe hidradenitis suppurativa. These data will support the planned regulatory submissions for povorcitinib in HS in Europe and the United States in 2025 and early 2026, respectively. The presentation will take place during a late-breaking oral presentation at the European Association of Dermatology and Venereology 2025 Congress. As previously reported, both STOP-HS1 and STOP-HS2 studies met their primary endpoint at each tested dose. A significantly higher proportion of patients treated with povorcitinib once daily versus placebo achieved Hidradenitis Suppurativa Clinical Response, a 50% reduction from baseline in the total abscess and inflammatory nodule count at Week 12, with no increase from baseline in abscess or draining tunnel count. In addition, at Week 12, more patients treated with povorcitinib compared to placebo, achieved HiSCR75, 3-point decrease in the Skin Pain Numeric Rating Scale score, and Skin Pain NRS30; additionally, fewer patients experienced a flare by Week 12. New data at Week 24 show nearly 60% of efficacy-evaluable patients among the povorcitinib 45 mg and 75 mg treatment groups achieved HiSCR50. Additionally, across STOP-HS1 and STOP-HS2, povorcitinib treatment in both dosing groups resulted in continued improvements at Week 24 in endpoints associated with higher thresholds of response: HiSCR75 was achieved by 31.0%-40.3%, HiSCR90 by 13.8%-27.7% and HiSCR100 by 9.2%-21.3% of patients treated with povorcitinib. Those treated with povorcitinib also achieved greater improvements in skin pain, reducing pain by the first visit through Week 24. Further, 62%-70% of povorcitinib-randomized patients achieved skin pain scores of mild or no pain at Week 24. In both studies, participants receiving povorcitinib 45 mg and 75 mg achieved dt100: 34.6% and 41.6% at Week 12 and 39.0% and 50.6% at Week 24, respectively. The overall safety profile of povorcitinib is consistent with previous data and both doses were well tolerated. Treatment-emergent adverse events for patients who transitioned from placebo to povorcitinib were 42.4%-54.3%, and 70.2%-78.7% for patients initially randomized to povorcitinib through Week 24. Serious adverse events, and adverse events of special interest were observed in 2.9%-4.8% and 0%-1.4% of patients. No MACE or deaths occurred during this period.