Incyte and CMS Collaborate to Develop Povorcitinib in Numerous Chinese Regions

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Incyte recently announced its new collaboration and license agreement with China Medical System Holdings Limited (CMS) for the research, development, and commercialization of povorcitinib in Mainland China, Hong Kong, Macao, Taiwan Region, and 11 Southeast Asian countries, as well as a non-exclusive license to manufacture povorcitinib in CMS’ territory.¹

Povorcitinib is a selective oral JAK1 inhibitor currently being evaluated for the treatment of non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma, and chronic spontaneous urticaria.

Based on their agreement, CMS will make an upfront payment to Incyte, and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of povorcitinib in CMS’ territory.

“We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options. There remains a significant need for new, innovative treatment for vitiligo and other immune-mediated dermatologic conditions, and we look forward to working together with the CMS team to bringing these products to market in China,” said Hervé Hoppenot, the Chief Executive Officer of Incyte, in the news release.

CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib. The transaction and agreement are effective immediately for both companies.

“We expect that this collaboration will enhance CMS Skinhealth's portfolio of potential treatments for vitiligo that, if approved, will provide differentiated treatment options for vitiligo patients in China. Upon approval, povorcitinib is poised to synergize with the innovative drugs in the commercialization stage of our pipeline Ilumetri (tildrakizumab injection), original/drugs including Hirudoid (mucopolysaccharide polysulfate cream) and Aethoxysklerol (polidocanol injection) in terms of our network and market resources, which will help the Product to realize its clinical and commercial value,” said Huang Anjun, the general manager of CMS Skinhealth, in the news release.

Recent Povorcitinib News

New late-breaking data on phase 2 safety and efficacy data of oral povorcitinib for prurigo nodularis was presented last month at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.²

In the phase 2 study of oral povorcitinib (NCT05061693), a small molecule JAK1-selective inhibitor, 126 adult patients with ≥20 pruriginous lesions, an Investigator’s Global Assessment (IGA) score of ≥3, prurigo nodularis for ≥3 months, and an average itch Numerical Rating Scale (NRS) score of ≥5 were randomized to receive once-daily povorcitinib (15, 45, or 75 mg) or placebo for 16 weeks.

The primary end point of the phase 2 study was a ≥4-point improvement in itch NRS score (NRS4) at week 16, which was achieved by significantly more patients who received povorcitinib(15mg: 36.1% [P=0.0066],45mg: 44.4% [P=0.0006], 75mg: 54.1% [P<0.0001]) vs placebo (8.1%).

Median times to NRS4 were 58.0 days for 15mg, 35.0 days for 45mg, and 17.0 days for 75mg povorcitinib vs not estimable for placebo. IGA Treatment Success (IGA score of 0 or 1 with a ≥2-grade improvement from baseline) at week 16 was achieved by 13.9%, 30.6%, and 48.6% of patients receiving povorcitinib (15, 45, and 75 mg, respectively) vs 5.4% for placebo.

First author Shawn Kwatra, MD, associate professor of dermatology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center, in Baltimore, Maryland, spoke to Dermatology Times at AAD 2024 about the significance of this phase 2 study and its results.

"I'm very thankful and have a lot of gratitude that I had the opportunity to have my hands all over the design of this trial. It was actually based on a lot of our laboratory's data, where we performed the first immunophenotyping studies from the skin and blood of prurigo nodularis patients. And in these patients, we looked at the different compartments and found high IL-22, from CD4+ CD8+ T-cells, high IL-4 and IL-13 in subsets, IL-31, and also IL-6," said Kwatra in his previous interview.

References

1. Incyte and CMS announce collaboration and license agreement for povorcitinib, an oral JAK1 inhibitor, in Mainland China, Hong Kong, Macau, Taiwan and Southeast Asia. News release. Incyte. April 1, 2024. Accessed April 1, 2024. https://investor.incyte.com/news-releases/news-release-details/incyte-and-cms-announce-collaboration-and-license-agreement-0
2. Martin M. Efficacy and safety of oral povorcitinib in patients with prurigo nodularis: results from a randomized, double-blind, placebo-controlled phase 2 study. Presented at: 2024 American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA.