Povorcitinib

2026年3月，在2026年美国皮肤病学会（AAD）年会上，Takeda、Alumis、Priovant和Incyte四家公司相继发布了关键临床数据，展示其在银屑病、特应性皮炎和化脓性汗腺炎等免疫皮肤病领域的最新突破。 口服小分子药物正成为行业焦点，有望重塑传统以注射生物制剂为主的治疗格局。 Takeda： Zasocitinib III期数据亮眼 Takeda公司公布了其高选择性口服TYK2抑制剂Zasocitinib（TAK-279）的两项III期临床试验（Latitude PsO 3001和3002）完整数据。 关键疗效数据： - 71.4%和69.2%的患者在第16周达到皮肤完全或几乎完全清除（sPGA 0/1），显著优于安慰剂（10.7%和12.6%）和阿普斯特（32%和30%），24周进一步提升。PAAI75在第16周分别达到76%和71%。 - 第16周，61%和52%的患者实现PASI 90（皮损面积和严重程度指数改善90%），24周PASI90持续提升到69%和63%。从第4周开始就展现出优于阿普斯特。 - 33.4%和25.2%的患者达到PASI 100（完全皮肤清除），安慰剂组仅为0.7%和1.1%；40%和34%患者达到sPGA0。从第8周开始持续优于阿普斯特。 安全性方面，Zaso的SAE（3%）略高于对照组，UTRI（10.1%）和痤疮（6.5%）比例大概是对照组的3倍左右。 Takeda研发总裁Andrew Plump博士指出，与竞品相比，Zasocitinib的差异化优势在于每日一次口服给药的便利性。公司计划于2026财年内向FDA提交新药申请。 Alumis： Envudeucitinib长期疗效获验证 Alumis公司发布了其TYK2抑制剂Envudeucitinib的II期STRIDE试验开放标签扩展研究数据。 关键疗效数据： 59.9%和53.1%的患者在第16周达到PASI 90（安慰剂组：4.8%和4.3%），应答率持续攀升至第24周，分别达到68.0%和62.1%。29.4%和27.7%的患者在第16周实现完全皮肤清除（安慰剂组：0.9%和0.9%），至第24周，完全清除率进一步提升至41.0%和39.5% 24周PASI90和PASI100曲线图也是从8周开始全面优于阿普斯特。整体和武田制药Zasocitinib相当。 Envudeucitinib治疗组sPGA-0/1和sPGA0比例也全面优于阿普斯特，数值上略低于武田制药的Zasocitinib（sPGA:40%和34%） 安全性方面，两个试验Envudeucitinib耐受性良好。痤疮比例（6%）显著高于对照组（0.7%），UTRI也差不多是对照组3倍。头疼的比例（10.3%）也高于对照组（2.5%）。 公司预计2026年上半年公布III期1年长期数据。 Priovant： Rosiglitazone亮相新英格兰医学杂志 Priovant Sciences在AAD 2026上展示了Brepocitinib治疗特应性皮炎的最新进展。该结果同步发表在新英格兰医学杂志。 研究设计： - 共有241例患者参与随机分组 - 患者被分为三组：Brepocitinib 30 mg组81例、Brepocitinib 15 mg组81例、安慰剂组79例 主要终点结果（第52周）： - Brepocitinib 30 mg组的平均总改善评分为46.5分，与安慰剂组相比差异为15.3分（95%置信区间6.7至24.0，P<0.001），差异具有统计学意义 - Brepocitinib 15 mg组的平均总改善评分为37.5分，与安慰剂组相比差异为6.3分（95%置信区间−2.4至14.9），差异无统计学意义 - 安慰剂组的平均总改善评分为31.2分 次要终点结果： - Brepocitinib 30 mg组在所有9项关键次要终点上均优于安慰剂组 - 这些终点包括皮肤疾病活动度、系统性糖皮质激素减量、功能残疾程度 - 疗效早在第4周即可观察到 安全性结果 - 严重感染在Brepocitinib 30 mg组更为常见，发生率为10%，而安慰剂组仅为1% - 试验期间未发生死亡病例 Incyte： Povorcitinib 54周数据惊艳， 有望成为首款化脓性汗腺炎（HS）口服药 Incyte公司公布了其高选择性JAK1抑制剂Povorcitinib（INCB54707）治疗中重度化脓性汗腺炎（HS）的III期STOP-HS项目54周长期数据。 突破性成果： 第12周，40%和42%患者达到HiSCR50，延长给药至54周，高达68%和71.4%的患者达到HiSCR50（脓肿和炎性结节计数减少≥50%）。 STOP-HS1试验75mg组有47.5%达到HiSCR75，28.8%达到HiSCR90。STOP-HS1试验45mg组高达57%的患者实现HiSCR75，75mg组有29.8%达到HiSCR90。 16.1%-20.2%的患者实现炎性病变完全清除（ANdT=0），54周治疗所有病灶类型持续改善。 在皮肤疼痛、疲劳和生活质量指标上均观察到显著改善 安全性方面，基本良好，54周贫血和血液CPK增加比例明显些。 Incyte炎症与自身免疫业务负责人Jim Lee博士表示，这些数据进一步强化了Povorcitinib作为首款HS口服治疗药物的潜力。目前该药针对HS的新药申请已获FDA优先审评，针对白癜风和结节性痒疹的III期数据预计分别于2026年中和第四季度公布。 结束语： 本次AAD 2026年会清晰展示了皮肤病治疗领域的范式转变。从Takeda和Alumis的TYK2抑制剂到Incyte的JAK1抑制剂，口服小分子药物正挑战传统生物制剂的市场地位。随着各公司加速推进监管审批，预计未来1-2年内将有多个口服新药获批，为数百万银屑病、特应性皮炎和化脓性汗腺炎患者带来更便捷、高效的治疗选择。 本文基于Endpoints News报道及AAD 2026年会公开资料整理

iStock, Kruck20 Presentations at the 2026 meeting of the American Academy of Dermatology not only demonstrate the therapeutic potential of next-generation skin drugs but also shed light on how they might fare on the market. The 2026 annual conference of the American Academy of Dermatology is in full swing, with skin disease experts flocking to Orlando, Florida, to present the latest developments in the field. Here, BioSpace reviews some of the most interesting and consequential readouts to come out of the meeting. Sanofi’s Amlitelimab Bows to Dupixent in Atopic Dermatitis Sanofi showed up at AAD 2026 with a trio of presentations on its anti-OX40L antibody amlitelimab, which it is developing for atopic dermatitis. Across the late-stage COAST-1, COAST-2 and SHORE studies, the pharma on Saturday touted what it called the “progressively increasing efficacy” of amlitelimab, both alone and in combination with other topical treatments. But analysts at Leerink Partners see it differently, writing in a Sunday note that amlitelimab’s efficacy in the “COAST-1 and COAST-2 trials were weaker compared with Dupixent.” This assessment was made cross-trial, the group noted, and in the absence of direct head-to-head studies, such comparisons will be inconclusive. In COAST-1, 35.9% of patients treated with amlitelimab every four weeks saw a 75% reduction at 24 weeks in the Eczema Area and Severity Index, a validated tool to measure disease severity in atopic dermatitis. In COAST-2, 41.8% of patients achieved this endpoint. Meanwhile, Leerink pointed out that 33% to 36% of Dupixent-treated patients in a separate study hit this outcome at 16 weeks. “We are reducing our amlitelimab sales projections by 50% following additional data disclosures,” Leerink said on Sunday. The firm now estimates 2032 sales will reach €650 million (around $745 million), down from its previous forecast of €1.3 billion (around $1.5 billion). Immunology and inflammation Sanofi Stumbles Again in Eczema—But Plans FDA Filing for OX40 Blocker Anyway The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.” January 23, 2026 · 2 min read · Tristan Manalac Read more Incyte’s JAK1 Blocker Delivers ‘Robust’ Hidradenitis Suppurativa Data Incyte’s oral drug candidate povorcitinib elicited and maintained response rates in patients with hidradenitis suppurativa (HS) through 54 weeks of follow-up—data that could help build the market’s confidence in the asset as it undergoes regulatory review. The Phase 3 STOP-HS1 and STOP-HS2 studies have together enrolled around 600 patients with mild or moderate HS who were treated with povorocitinib or placebo. Results presented at AAD on Saturday showed that Incyte’s drug could maintain its therapeutic benefit through 54 weeks of follow-up, sustaining what the company called “clinically meaningful and durable responses.” Up to 71.4% of patients showed at least a 50% reduction in total abscess and inflammatory nodule counts without an accompanying increase in abscesses or draining tunnel counts, according to the company’s news release. Povorocitinib also eased three key inflammatory lesion types throughout the follow-up, with 16.1% to 20.2% of patients achieving the full clearance of these lesions at 54 weeks. Analysts at William Blair called these findings “robust” in a Monday note to investors, though they noted that some commercial questions remain, especially about how povorocitinib will square up against AbbVie’s Rinvoq. Roivant Reinforces Brepocitinib’s ‘Compelling’ Pro Dermatomyositis Roivant, through one of its “Vant” spinouts Priovant, is advancing the TYK2/JAK1 dual inhibitor brepocitinib for dermatomyositis, a rare autoimmune disorder causing muscle weakness and rashes. On Saturday at AAD, the company touted “rapid and statistically significant reductions in itch,” as measured by scores on the peak pruritus numerical rating scale. At week 4, 18.9% more patients on brepocitinib achieved itch remission than did placebo comparators. Roivant also reported improvements in patient-reported, skin-related quality of life through 52 weeks of follow-up. Moreover, in patients who had moderate-to-severe disease at baseline and who were refractory to standard treatments, brepocitinib elicited a 26.6% greater rate of functional skin remission versus placebo. These data for brepocitinib “reinforce its compelling pro support our positive outlook on its commercial prospects,” analysts at Leerink told investors in a Sunday note. Brepocitinib earlier this month announced that the FDA has accepted the approval application for brepocitinib in dermatomyositis, with a decision expected in the third quarter. Immunology and inflammation Priovant Plots Path to Phase 3 as Brepocitinib Clears Mid-Stage Skin Disease Study According to Priovant, the Phase 2 BEACON study is the first industry-sponsored placebo-controlled trial in cutaneous sarcoidosis to deliver positive data. February 6, 2026 · 2 min read · Tristan Manalac Read more Alumis Plots Path Forward for Plaque Psoriasis Pill Alumis on Saturday presented back-to-back readouts from its Phase 3 ONWARD1 and ONWARD2 studies testing the next-generation TYK2 inhibitor envudeucitinib for plaque psoriasis. The biotech is planning to the drug’s approval in the second half of 2026. At 16 weeks, 53.1% to 59.9% of envudeucitinib-treated patients showed clinical response, as measured by a 90% reduction in Psoriasis Area and Severity Index (PASI-90) scores. By comparison, 4.3% to 4.8% of placebo counterparts hit this outcome. Clinical response benefits were apparent as early as four weeks, Alumis reported. PASI-100, which indicates complete skin clearance, was documented in 27.7% to 29.4% of envudeucitinib-treated patients at 16 weeks, growing to 39.5% to 41% at 24 weeks. Envudeucitinib treatment also improved scalp psoriasis, dermatology-related quality of life and itch relief as compared with placebo. As for safety, Alumis said that envudeucitinib was well tolerated over the 24 weeks of observation, with no clinically significant laboratory anomalies or episodes of tuberculosis.