Results of Phase 2 Study Evaluating Hidradenitis Suppurativa Drug Announced

Incyte reported 52-week data from its Phase 2 study, evaluating the efficacy and safety of povorcitinib (formerly INCB54707) in adult patients with hidradenitis suppurativa (HS).¹

The study results showed that longer-term treatment with povorcitinib 75 mg resulted in sustained and durable efficacy in patients with the condition. Results include a 36-week open-label extension period during which all patients received povorcitinib 75 mg once daily (QD), which showed that average efficacy was sustained for all treatment arms following the switch to povorcitinib 75 mg QD. The drug also demonstrated durable efficacy at Week 52 in high-threshold outcomes; 22-29% of patients achieved HS Clinical Response 100 (HiSCR100), which is defined as a 100% reduction from baseline in total Abscess and Inflammatory Nodule (AN) count with no increase from baseline in abscess or draining tunnel count.

A primary endpoint at Week 16, the double-blind, placebo-controlled portion of the study, showed patients who received povorcitinib QD had significantly greater decreases from baseline in AN count versus placebo. Povorcitinib was well-tolerated and its safety profile was consistent with previously reported data. The most common adverse effects at Week 52 were Covid-19 (21.3%), acne (11.5%), upper respiratory tract infection (10.9%), headache (5.7%), nasopharyngitis (5.7%), urinary tract infection (5.7%) and increased blood creatine kinase (CK) (5.2%). Increased CK levels may suggest muscle damage or disease.

Kurt Brown, M.D., Global Program Head, Povorcitinib, and Associate Vice President, Drug Development, Inflammation & AutoImmunity, Incyte, said he was encouraged by the data and believes it reinforces the potential of the drug to be a safe and efficacious treatment for HS that is tolerable with longer-term administration, even at higher doses.

Povorcitinib is an oral small-molecule Janus Kinase (JAK) 1 inhibitor currently in Phase 2 clinical trials for HS, vitiligo and prurigo nodularis. A Phase 3 study in HS is also ongoing to treat patients with moderate-to-severe HS. The data was delivered as an oral presentation at the 12th Conference of the European Hidradenitis Suppurativa Foundation, held from February 8-10, 2023, in Florence, Italy.

Reference

1. Incyte announces 52-week results from Phase 2 study evaluatingpovorcitinib(INCB54707) in patients with hidradenitis suppurativa. Incyte. Press release. Published February 10, 2023. Accessed February 10, 2023. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-52-week-results-phase-2-study-evaluating