Incyte is preparing to take an oral JAK inhibitor into phase 3 trials for the skin depigmentation disease vitiligo, after reporting mid-stage data showing efficacy in patients with facial and full-body symptoms.

在报告显示面部和全身症状患者有效的中期数据后，Incyte正在准备将口服JAK抑制剂用于皮肤脱色疾病白癜风的3期临床试验。

Last year, Incyte became the first pharma company to get approval for a drug that can repigment the skin in vitiligo – topical JAK1/JAK2 inhibitor Opzelura (ruxolitinib) – for patients whose lesions cover 10% of the body or less.

去年，Incyte成为第一家获得批准的药物，该药物可以使白癜风皮肤色素沉着-局部JAK1/JAK2抑制剂Opzelura（ruxolitinib）-适用于病变覆盖身体10%或更少的患者。

New drug candidate povorcitinib is a selective JAK1 inhibitor, given as a once-daily oral dose, which is intended to treat patients with more extensive forms of non-segmental vitiligo, the most common form of the autoimmune disease, which affects around 1.5 million people in the US alone.

新药候选药物povorcitinib是一种选择性JAK1抑制剂，以每日一次的口服剂量给药，旨在治疗更广泛形式的非节段性白癜风患者，这是最常见的自身免疫性疾病形式，影响约150万人仅在美国。

Overactivity of the JAK signalling pathway is believed to drive inflammation involved in the development and progression of vitiligo.

据信JAK信号传导途径的过度活跃驱动参与白癜风发展和进展的炎症。

New 52-week results from a dose-ranging phase 2b study of povorcitinib found that average total-body improvements in the area of skin affected by vitiligo – measured using the T-VASI scale – were upwards of 40%, depending on the dose used, compared to 18% with a placebo.

来自povorcitinib剂量范围2b期研究的新的52周结果发现，使用T-VASI量表测量的受白癜风影响的皮肤区域的平均总体改善超过40%，这取决于所使用的剂量，而安慰剂组为18%。

More on-treatment patients achieved a 50% or greater reduction from baseline in T-VAS, at around 45% of the povorcitinib group and 15% in the control arm. Meanwhile, in a subgroup of patients with facial depigmentation, the improvements were around 64% with the JAK1 inhibitor and 55% with placebo.

更多的治疗中患者的T-VAS比基线降低50%或更多，约为povorcitinib组的45%和对照组的15%。同时，在面部色素脱失患者亚组中，JAK1抑制剂的改善率约为64%，安慰剂组为55%。

In both cases, the treatment showed improvement over an earlier readout from the study at 24 weeks, suggesting that the benefit was increasing over time.

在这两种情况下，治疗均显示出比24周时研究的早期读数有所改善，这表明该益处随着时间的推移而增加。

“Vitiligo often has a significant impact on patients’ lives, and there is a need for new treatment options that can offer solutions to people with extensive disease who desire repigmentation,” commented study investigator Khaled Ezzedine of Henri Mondor Hospital and EpiDermE, Université Paris.

Henri Mondor医院的研究人员Khaled Ezzedine和UniversitéParis的EpiDermE评论说：“白癜风通常会对患者的生活产生重大影响，需要新的治疗方案，为需要色素沉着的广泛疾病患者提供解决方案。”。

Incyte’s dermatology business has assumed greater importance for its future growth since its oral Jakafi formulation of ruxolitinib, used to treat myelofibrosis, polycythemia vera, and graft-versus-host disease, saw new competition arrive on the market last month with the FDA approval of GSK’s Ojjaara (momelotinib)..

Incyte的皮肤科业务对其未来的发展具有更大的重要性，因为它的口服Jakafi配方ruxolitinib用于治疗骨髓纤维化，真性红细胞增多症和移植物抗宿主病，上个月随着FDA批准GSK的Ojjaara（momelotinib）。。

Jakafi accounted for $682 million of Incyte’s second-quarter sales of $827 million, with Opzelura - which is also approved for atopic dermatitis - contributing $80 million in the period from sales in the US as well as Germany and Austria in Europe.

Jakafi占Incyte第二季度销售额8.27亿美元的6.82亿美元，Opzelura（也被批准用于特应性皮炎）在美国以及德国和奥地利在欧洲的销售期间贡献了8000万美元。

Along with vitiligo, povorcitinib is also in phase 3 testing for hidradenitis suppurativa, and phase 2 for prurigo nodularis, chronic spontaneous urticaria and asthma.

与白癜风一起，povorcitinib也正在进行化脓性汗腺炎的3期临床试验，结节性痒疹，慢性自发性荨麻疹和哮喘的2期临床试验。

Photo by Hosein Shirvani on Unsplash

照片由Hosein Shirvani在unflash上拍摄