Incyte has released the results of a new 52-week trial evaluating the efficacy and safety of povorcitinib, an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS). The results showed that the status of the abscess and inflammatory nodules in the patients with HS was significantly improved at 16 weeks of medication, which has lasted for 52 weeks.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder characterized by painful nodules and abscesses. HS can lead to irreversible tissue damage and scarring, with profound negative effects on patients' quality of life. Inflammatory activity associated with overactivation of the JAK/STAT signaling pathway is thought to drive the onset and progression of HS. It is estimated that there are more than 150,000 moderate to severe HS patients in the United States alone.
Povorcitinib, an oral small-molecule JAK1 inhibitor from Incyte, is in phase 2 trials for indications such as HS, vitiligo and nodular pruritus. The results presented here are from a Phase 2, randomized, double-blind, placebo-controlled dose-range trial to evaluate the efficacy and safety of povorcitinib in adult patients with HS.
The first part of the 16-week trial enrolled 209 adult HS patients (18-75 years of age) who were randomly assigned to receive one daily dose of povorcitinib or placebo in a 1:1:1:1 ratio: 15 mg (n=52), 45 mg (n=52), 75 mg (n=53), or placebo (n=52). The primary efficacy endpoint for this part of the trial was the mean change in abscess and inflammatory nodule (AN) count from baseline at week 16. The key secondary endpoint was the percentage of patients who achieved a clinical response to HS at week 16 (HiSCR; The AN count decreased by ≥50% from baseline, and the number of abscesses or draining tunnels did not increase).
The second part of the trial, the Open Label Extension Phase (OLE), lasted 36 weeks (out of a total of 52 weeks) and included patients enrolled in the first part of the trial. OLE stage subjects (n=174) received povorcitinib 75 mg once daily. After week 52, patients who completed baseline, week 16, and week 52 assessments could continue to receive an additional dose of 75 mg povorcitinib once daily for 48 weeks.
End points at week 52 included AN count, HiSCR, and HiSCR75/90/100 compared to baseline (AN count reduced by ≥75%, 90%, 100% compared to baseline, No increase in the number of abscesses or drainage channels), HS inflammation occurrence, HS severity scale score IHS4, and HS4 score reduction from baseline of ≥55%/75%/90%/100% mean change. The safety of povorcitinib was also evaluated.
At the pretrial stage, the trial had already met its primary endpoint: at week 16, patients treated with povorcitinib once a day had significantly higher reductions in abscess and AN count relative to baseline than those in the placebo group.
The new results included a 36-week OLE trial, during which all patients received 75 mg of povorcitinib once a day. Mean response was maintained across all treatment cohorts. Povorcitinib treatment showed a lasting response at week 52, with 22-29% of patients achieving HS clinical response 100 (HiSCR100) -- a 100% reduction in total AN counts from baseline and no increase in abscess or drainage channel counts from baseline.
Povorcitinib was generally well tolerated and its safety profile was consistent with previously reported data. At week 52, The most common treatment-related adverse events (TEAEs) (n=174) were COVID-19 (21.3%), acne (11.5%), upper respiratory infections (10.9%), headache (5.7%), nasopharyngitis (5.7%), urinary tract infections (5.7%), and elevated blood creatine kinase (CK) (5.2%). A total of six patients (3.4%) had TEAE that led to the discontinuation of treatment. No fatal TEAEs were observed during treatment.
"HS is a chronic, progressive, debilitating disease with no cure," said Kurt Brown, Ph.D., Incyte's vice president of drug Development, Inflammation and Autoimmunity and global program leader for povorcitinib. We are encouraged by these phase 2 data, which reinforce the potential of povorcitinib as a safe, effective treatment for HS that is tolerable even at higher doses. Although there are treatments available for HS, no universally effective treatment has been found, highlighting the need for other treatment options. We look forward to continuing to advance the development of povorcitinib through our ongoing Phase 3 trial in moderate-to-severe HS patients."

Reference materials: [1] Incyte Announces 52-Week Results from Phase 2 Study Evaluating Povorcitinib (INCB54707) in Patients with  Hidradenitis Suppurativa, Retrieved Feb 13 th, 2023 from https://www.businesswire.com/news/home/20230210005205/en
Disclaimer: Wuxi Apptec's content team focuses on global progress in biomedical health research. This article is for informational purposes only. The views expressed in this article do not represent the position of Wuxi AppTec, nor do they represent that Wuxi AppTec supports or disagrees with the views expressed in this article. This article is not a treatment recommendation. For guidance on treatment options, visit a regular hospital.

[Copyright Note] Lianchuang Biopharmaceutical published the original article and reprint the article. The purpose of reprinting articles is to recommend valuable information, share with more friends, we respect intellectual property rights, committed to protect intellectual property rights, do our best to credit the author and source. If we reprint articles, pictures and other content copyright problems, please contact us at 0551-68596228, we will try our best to contact you as soon as possible, timely processing. Thank you for your understanding and help!