A Phase I Randomized, Double-Blind, Placebo-Controlled, Multiple Oral Dose Trial to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IBI353 (Orismilast) in Healthy Subjects

This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.

开始日期2022-11-30

申办/合作机构

信达生物制药（苏州）有限公司

CTR20222393 / Completed临床1期

评估IBI353在中国健康受试者中多次口服给药的药代动力学、安全性和耐受性的随机、双盲、安慰剂对照、I期临床研究

主要目的：评估IBI353在中国健康受试者中多次口服给药后的药代动力学特征。次要目的：评估IBI353在中国健康受试者中多次口服给药后的安全性和耐受性。

开始日期2022-11-24

申办/合作机构

信达生物制药（苏州）有限公司

[+2]

NCT05469464 / Active, not recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

开始日期2022-07-11

申办/合作机构

UNION Therapeutics A/S

100 项与 Orismilast 相关的临床结果

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100 项与 Orismilast 相关的转化医学

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100 项与 Orismilast 相关的专利（医药）

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项与 Orismilast 相关的文献（医药）

2025-01-01·Dermatologic Clinics

Innovations in Psoriasis

Review

作者: Martin, Amylee ; Ibraheim, Marina Kristy ; Gupta, Rohit ; Wu, Jashin J. ; Wu, Jashin J

Despite numerous effective biologics for treating psoriasis, new treatments continue to be investigated due to an unmet need for certain patient populations. This review discusses therapies that were recently Food and Drug Administration (FDA)-approved for treating psoriasis, including the topical agents tapinarof and roflumilast, deucravacitinib, an oral small molecule that selectively inhibits tyrosine kinase 2, and spesolimab, a monoclonal antibody inhibiting interleukin-36 that became the first FDA-approved treatment for generalized pustular psoriasis flares. Other therapies are in the pipeline, such as orismilast, as well as Mind.Px, a tool for predicting biological response, is also highlighted.

2024-05-01·Journal of the European Academy of Dermatology and Venereology

Orismilast for the treatment of mild to severe hidradenitis suppurativa: Week 16 data from OSIRIS, a Phase 2a, open‐label, single‐centre, single‐arm, dose‐finding clinical trial

Article

作者: Frederiksen, C G ; Saunte, D M ; Jemec, G B E ; Sedeh, F B ; Taudorf, E H

AbstractBackgroundHidradenitis suppurativa (HS) is a disease with an unmet need for treatment.ObjectiveTo examine tolerability, safety and efficacy of oral phosphodiesterase‐4 (PDE4) inhibitior orismilast 10–40 mg twice daily (BID) in HS.MethodsA Phase 2a, single‐arm, single‐centre, open‐label, 16‐week trial in HS patients. Adjustments in maximal dose and titration were allowed, to improve tolerability, dividing the study population in two groups who completed and discontinued 16 weeks of treatment.Descriptive statistics were applied to efficacy data from patients who completed treatment and patients who discontinued treatment prematurely. A last‐observation‐carried‐forward (LOCF) approach was used for patients who discontinued treatment.The primary endpoint was percent change in the total number of abscesses and nodules (AN‐count) at Week 16, with the HS Clinical Response with a 50% reduction in the AN‐count (HiSCR50) as key secondary endpoint.ResultsOf the 20 patients included, 9 completed 16 weeks of treatment and 11 discontinued treatment prematurely. The mean AN‐count was reduced with 33.1% in patients who completed treatment and with 12.0% in patients who discontinued. HiSCR50 was achieved by 67.0% and 27.0% of patients who completed and discontinued treatment, respectively. Most adverse events were mild to moderate.ConclusionsOral orismilast demonstrated a dose‐dependent tolerability, with mild to moderate adverse effects. Further, the results of this exploratory trial indicate that orismilast may lead to clinical improvements in HS. However, larger trials with tolerable dose ranges are warranted.The Trial is registered at Clinicaltrials.gov (UNI50007201) and EudraCT.ema.europa.eu (2021‐000049‐42).

2024-03-01·Journal of the American Academy of Dermatology

Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS)

Article

作者: Mrowietz, Ulrich ; Soerensen, Per ; French, Lars E ; Strober, Bruce E ; Gooderham, Melinda ; Kjøller, Kim D ; Sommer, Morten O A ; Blauvelt, Andrew ; Andres, Philippe ; Carlsson, Anna ; Hunter, Hamish J A ; Langley, Richard G ; Warren, Richard B ; Egeberg, Alexander

BACKGROUNDOrismilast is a novel oral phosphodiesterase-4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis.OBJECTIVETo evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis.METHODSThis multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419). Efficacy end points were analyzed using multiple imputation.RESULTSOf 202 randomized patients, baseline characteristics were balanced across arms, except greater severe disease proportions for orismilast vs placebo. Orismilast showed significant improvements in the primary end point, percentage change in Psoriasis Area and Severity Index (PASI), from baseline to week 16 (orismilast -52.6% to -63.7% and placebo, -17.3%; all P <.001). Greater proportions receiving orismilast achieved PASI75 (39.5%-49.0%; P <.05) and PASI90 (22.0%-28.3%; P <.05 for 20 and 40 mg) vs placebo (PASI75, 16.5% and PASI90, 8.3%) at week 16. Safety findings were as expected with PDE4 inhibition; dose-dependent tolerability effects observed.LIMITATIONSSmall sample size, disease severity imbalance between groups, limited duration and diversity in study population.CONCLUSIONOrismilast demonstrated greater efficacy vs placebo and a safety profile in line with PDE4 inhibition.

项与 Orismilast 相关的新闻（医药）

2024-11-14

·Insight数据库

信达生物正在下一盘大棋

从 Biotech 蜕变为 BioPharma 并非易事，真正能成功转型的寥寥无几。然而，信达生物不仅以丰富的产品线完成了蜕变，还布下一盘大棋局，储备了梯队合理的管线，冲刺「2027 年国内产品收入达到 200 亿元」的目标。冲刺 200 亿目标信达生物距离 200 亿目标还有多远？凭借「自主研发+战略引进」双轮驱动的策略，如今信达的商业化产品已扩充至 11 款，覆盖了多个疾病领域，其中抗肿瘤产品 9 个、自免产品 1 个、心血管产品 1 个。 2024 年前三季度，信达实现产品总收入超过 61 亿元，较上年同期增长约 51%，主要得益于信迪利单抗和其他产品的出色表现，以及新产品的加速增长及贡献增加。信迪利单抗是信达的业绩支柱产品，目前已斩获 7 个适应症，今年上半年实现销售额达 2.4 亿美元（约合人民币 16.95 亿元），同比增长 46%，第三季度仍保持强劲增长势头。而且，信迪利单抗的增长尚未触及天花板，信达正在通过开展联合疗法、持续拓展新适应症，延长产品高销售额的生命周期。今年 4 月，信迪利单抗联合呋喹替尼治疗二线子宫内膜癌的上市申请获国家药监局受理；而且，还有多项 Ⅲ 期研究在进行中，包括针对非小细胞肺癌围手术期、联合 IBI310（CTLA-4）用于结直肠癌新辅助治疗。信达生物 11 款获批上市的产品数据来源：Insight 数据库信达生物能否在业绩层面更胜一筹，是市场最为关注的焦点。就现有产品而言，抗肿瘤领域的奥雷巴替尼、氟泽雷塞，以及心血管领域的托莱西单抗均颇有市场前景。奥雷巴替尼是亚盛医药研发的中国首个三代 BCR-ABL 抑制剂，目前已获批 2 项适应症：治疗任何 TKI 耐药、并伴有 T315I 突变的慢性髓细胞白血病（CML）慢性期（-CP）和加速期（-AP）的成年患者，以及治疗对一代和二代 TKI 耐药和/或不耐受的 CML-CP 成年患者。奥雷巴替尼在中国的商业化推广由亚盛和信达共同负责，自 2021 年 11 月上市以来已累计实现含税销售额近 5 亿元。尤其是今年 6 月，武田制药以总额 13 亿美元拿下了奥雷巴替尼在大中华区以外的全球权益，更加凸显其市场潜力。氟泽雷塞是劲方医药研发的中国首个 KRAS G12C 抑制剂，已于今年 8 月获批用于治疗至少接受过一种系统性治疗的 KRAS G12C 突变型晚期 NSCLC 成人患者，填补了 40 年中国 KRAS G12C 突变靶向治疗的空白。信达在 2021 年以交易总额 3.12 亿美元获得了氟泽雷塞在中国地区的权益，并拥有全球开发和商业化权益的选择权。托莱西单抗是信达布局心血管疾病领域的首款产品，也是首个国产 PCSK9 抑制剂，已于去年 8 月获批用于治疗原发性高胆固醇血症（包括杂合子型家族性和非家族性高胆固醇血症）和混合型血脂异常。除已上市产品外，后续管线的商业化落地也将是信达生物冲刺 200 亿目标的新增长引擎。抗肿瘤管线全面开花近两年还有 2 款新产品获批抗肿瘤产品是信达生物实现收入大幅增长的「功臣」，后续管线组合自然也十分丰富，覆盖了小分子、单抗、多抗、ADC 等多种药物形式，涉及 ROS1、EGFR、ClDN18.2、HER3 和 B7-H3 等众多靶点。其中，进展最快的他雷替尼（IBI344）、利厄替尼，均已提交上市申请。他雷替尼是信达从葆元医药（已被 Nuvation Bio 收购）引进的新一代潜在最佳 ROS1 抑制剂，拥有大中华区的权益，目前已向 NMPA 提交 2 项适应症的上市申请：包括用于经 ROS1-TKI 治疗失败的 ROS1 阳性局部晚期或转移性 NSCLC 成人患者，以及一线治疗上述适应症。两个适应症均有望在今年 Q4 获批。截图来源：Insight 数据库利厄替尼是奥赛康研发的第三代 EGFR 抑制剂，已提交 2 项适应症的上市申请：包括既往经 EGFR-TKI 治疗时或治疗后出现疾病进展，并且经检测确认存在 EGFR T790M 突变阳性，或原发性 EGFR T790M 突变阳性的局部晚期或转移性 NSCLC 成人患者的治疗，预计 2026 Q3 获批。一线治疗具有 EGFR 外显子 19 缺失（19DEL）或外显子 21 置换突变（L858R）的局部晚期或转移性 NSCLC 成人患者，预计 2025 Q1 获批。今年 10 月，信达与奥赛康达成战略合作，将在中国地区独家推广销售利厄替尼，并向奥赛康支付首付款、注册里程碑和销售里程碑款项。截图来源：Insight 数据库信达在肿瘤领域的亮点还有多抗：拥有全球首创 PD-1/IL-2α 双抗融合蛋白 IBI363 目前正在中国、美国、澳大利亚同时开展Ⅰ/Ⅱ期研究，今年 9 月还获得 FDA 快速通道资格认定，用于治疗黑色素瘤。该药在解决免疫治疗（IO）抵抗和冷肿瘤患者的未满足临床需求方面具有巨大潜力。全球首个且目前唯一进入临床阶段的 DR5×CEA 双抗 IBI3004。该药正在澳洲和中国内地开展治疗结直肠癌等实体瘤的Ⅰ/Ⅱ期研究；全球首款靶向 B7-H3/EGFR 的双抗 IBI334，正在开展针对晚期实体瘤的 I/II 期临床研究；还有一款靶向 GPRC5D/BCMA/CD3 的三抗 IBI3003，正在国内开发用于治疗复发或难治性多发性骨髓瘤的 I 期研究，进度处于全球第一梯队。为了深度布局「IO+ADC」，目前信达已有 7 款 ADC 药物进入临床阶段，包括 IBI343（CLDN18.2 ADC）、IBI354（HER2 ADC）、IBI130（TROP2 ADC）、IBI129（B7 H3 ADC）、IBI133（HER3 ADC）、IBI3009（DLL-3 ADC）、IBI3001（全球首创 EGFR/B7 H3 双抗 ADC）。 IBI343 进度最快，正在开展国际多中心 Ⅲ 期研究，并已在 I 期试验中展现出积极疗效：6 mg/kg 剂量组针对 CLDN18.2 高表达胃癌患者的 ORR、DCR 分别为 36.7%、93.3%，中位无进展生存期长达 6.8 个月。 IBI354 在 I/II 期试验展示出对乳腺癌、卵巢癌等多个癌种积极的早期疗效信号和优异的安全性； IBI130 正在澳洲开展 I/II 期试验； IBI133 正在国内和澳洲开展 I/II 期试验； IBI3009 正在澳洲开展针对小细胞肺癌和其他神经内分泌癌的Ⅰ期试验。自免、代谢、眼科，研发版图再扩张除肿瘤管线外，信达生物还在自免、眼科、心血管及代谢领域撒下火种。自免领域，管线的靶点差异化优势显著，包括 IBI112（IL-23p19 抑制剂）、IBI353（Orismilast）、IBI355（CD40L 抗体）、IBI356（OX40L 单抗）、IBI3002（全球首创 IL-4Rα/TSLP 双抗）。其中，IBI112（匹康奇拜单抗）进度最快，已在中国申报上市用于治疗中重度斑块状银屑病，预计在 2026 年 Q1 获批；针对溃疡性结肠炎的 II 期临床也已达到主要终点。 Orismilast 是治疗炎症性皮肤病的潜在同类最佳 PDE4 抑制剂，已在中度至重度银屑病研究中显示出积极结果，信达在 2021 年以总额 2.67 亿美元从 UNION Therapeutics 引进了大中华区权益。代谢领域中，信达布局的 GLP-1R/GCGR 双重激动剂玛仕度肽，有望成为下一个爆发点。目前已提交用于减重和 2 型糖尿病两大适应症的上市申请，预计 2025 年 Q3 可获批，并有多个 III 期研究在进行中。截图来源：Insight 数据库同类竞品中，今年前九个月司美格鲁肽、替尔泊肽分别实现销售额高达 203.24 亿美元、110.28 亿美元。根据国联证券研报，相比于司美格鲁肽及替尔泊肽，玛仕度肽使用了更简便的给药方案，可快速到达最大维持剂量，提升用药早期的减重效果，也减少了患者调整药物剂量的次数，提高患者依从性。此外，信达还在心血管及代谢领域布局了 IBI128（替古索司他片）、IBI-3016（AGT siRNA）。其中，替古索司他片是一款治疗痛风的全新的黄嘌呤氧化酶抑制剂（XOI），信达在 2022 年以超 9500 万美元从韩国 LG 化学引进了中国的权益，目前 LG 化学正在开展两项 Ⅲ 期研究。 IBI3016 是一款靶向血管紧张素原（AGT）的变革性 siRNA 创新疗法，具备药效持久且安全耐受性良好的优势，用于治疗患者数量庞大的高血压，目前正在开展 I 期研究。在眼科领域，信达即将迎来首个商业化产品——替妥尤单抗（IBI311）。替妥尤单抗已提交用于治疗甲状腺眼病（TED）的上市申请，是中国首个申报上市的 IGF-1R 抗体，预计 2025 年 Q2 获批。目前在研的同类竞品不多、竞争格局良好，而且全球首款且唯一获批的 IGF-1R 单抗 Tepezza，2022 年销售额高达近 20 亿美元，足见该类药物的市场价值。截图来源：Insight 数据库除替妥尤单抗外，信达还针对眼科领域的明星靶点 VEGF 进行了深度布局，拥有全球首创抗 VEGF-抗补体双特异性融合蛋白 IBI302（Ⅲ期临床）、IBI324（VEGF/Ang2 双抗）、IBI333（VEGF-A/VEGF-C 双抗）等多个管线。 IBI302 在针对新生血管性年龄相关性黄斑变性（nAMD）的临床 II 期研究中展现出了积极的治疗效果，以及长间隔给药的潜力，有望解决以往 VEGF 药物需频繁注射的问题。要知道，罗氏治疗 nAMD 的法瑞西单抗（Vabysmo），之所以能在短时间内实现惊人的高速增幅，在今年前三季度实现超 30 亿美元的销售额，就是因为提供了便捷的给药方式。结语多个疾病领域全面开花的棋局，可谓相当的有看头。可如果把目光放得更长远，信达若想继续走出持续高增长轨迹，必然还得做好国际化市场，毕竟这是关乎未来发展的关键战役。但从现在的情形看，信达的海外管线推进速度还是不够快，大多仍处于早期临床阶段。反观，许多 Biotech 的收入结构都逐渐进阶成了「商业化+源源不断的合作收入」，而信达在 BD 出海、在国际化的布局方面，显然还需要加快速度。参考资料： 1. 信达生物财报、公告、官微 2.Insight 数据库 3. 国联证券研报封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期上市批准申请上市财报

2024-09-26

·药明康德

潜在“first-in-class”湿疹疗法挺进3期临床；基因疗法新锐完成约5200万美元B轮融资

▎药明康德内容团队编辑潜在“first-in-class”特应性皮炎疗法2期临床结果积极 UNION Therapeutics今天宣布，其潜在“first-in-class”口服疗法orismilast在治疗中度至重度特应性皮炎成人患者的2b期临床试验ADESOS中获得积极结果。基于这一进展，该公司计划推进这款疗法进入3期临床试验。研究中随机分配的233名患者的数据表明，与安慰剂组（n=55）相比，orismilast的20 mg（n=58）、30 mg（n=61）和40 mg（n=59）剂量组在第16周时让更多患者达到了研究者总体评估（IGA）评分为0或1的缓解标准（比例分别为26.3%、24.3%、30.9%和9.5%；所有p<0.05）。此外，所有治疗组在第2周时的瘙痒数值评分（NRS）均表现出显著的≥4点的减轻，与安慰剂相比获得显著改善（p<0.05）。 Orismilast是一种新一代高效磷酸二酯酶4（PDE4）抑制剂，靶向与炎症相关的PDE4B/D亚型，表现出对Th1、Th2和Th17通路的强效抑制作用。它在炎症级联反应的早期阶段起作用，诱导对多种皮肤和免疫疾病相关的多种细胞因子的广泛抗炎作用。Orismilast的开发旨在比上市的PDE4抑制剂具有更强的抗炎特性，这得益于其对PDE4B和D亚型的更高选择性。新锐完成4600万欧元B轮融资，开发基于慢病毒载体的基因疗法 Genespire今日宣布完成4600万欧元（约5200万美元）的B轮融资，获得资金将支持该公司的核心候选产品GENE202的开发，直至进入治疗甲基丙二酸血症（MMA）的1/2期临床试验。MMA是一种破坏某些氨基酸和脂肪代谢的严重遗传疾病，通常在婴儿早期发病，伴随高死亡率，临床表现包括肌无力、癫痫、发育迟缓和器官损伤。目前，尚无针对MMA的改变疾病进程的治疗方法。 GENE202是一种现货型基因疗法，利用了该公司的免疫屏蔽慢病毒载体（ISLV）平台。GENE202设计为可静脉注射，使患者的肝脏终生产生该疗法。ISLV的作用机制使Genespire的治疗方法特别适用于当前面临最紧迫未满足医疗需求的遗传病儿童患者，同时也能惠及成人患者。本轮B轮融资还将加强公司产品管线，促进针对多种其他遗传疾病候选疗法的发现和临床前研究。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] UNION therapeutics announce results from the ADESOS Phase 2b study in atopic dermatitis confirming the potential of orismilast as a first-in-class safe and efficacious oral treatment. Retrieved September 25, 2024, from https://www.prnewswire.com/news-releases/union-therapeutics-announce-results-from-the-adesos-phase-2b-study-in-atopic-dermatitis-confirming-the-potential-of-orismilast-as-a-first-in-class-safe-and-efficacious-oral-treatment-302258828.html [2] Genespire raises €46.6 million (~$52 million) in a Series B round to advance its first pediatric in-vivo gene therapy into the clinic. Retrieved September 25, 2024, from https://www.genespire.com/wp-content/uploads/2024/09/240925-Genespire-Series-B-press-release-FINAL.pdf 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

基因疗法临床结果临床3期

2024-09-26

·Pharmaceutical Technology

Union plans Phase III trial for atopic dermatitis after Phase IIb win

Orismilast is a phosphodiesterase-4 (PDE4) inhibitor, which impacts multiple inflammatory mediators causing a pro-inflammatory effect. Image credit: Evgeniia Primavera / Shutterstock. Union Therapeutics is looking to advance its PDE4 inhibitor, orismilast, into a Phase III clinical trial for atopic dermatitis (AD) following positive results from a Phase IIb study for the therapy in the indication. The company is investigating orismilast for multiple dermatological and inflammatory indications , including psoriasis, hidradenitis suppurativa, and ulcerative colitis. Union plans to start a Phase III trial for the therapy in AD once the US Food and Drug Administration (FDA) approves the trial design at an end-of-Phase II meeting. The results from the dose-ranging Phase IIb ADESOS trial (NCT05469464) were presented at the European Academy of Dermatology and Venerology (EADV) 2024 Congress taking place from 25 to 28 September in Amsterdam, Netherlands. “The results from the ADESOS study with orismilast in AD follows positive readouts in psoriasis and hidradenitis suppurativa confirming the potential of orismilast as a safe oral treatment option across immunology,” said Kim Kjøller, co-CEO of Union. Orismilast is a phosphodiesterase-4 (PDE4) inhibitor, which impacts multiple inflammatory mediators causing a pro-inflammatory effect. In 2021, Union licensed out the development and marketing rights to the therapy in China to Innovent Biogics in a deal worth more than $267m. See Also: MHLW approves MSD’s KEYTRUDA for lung and urothelial cancers MHLW approves Eli Lilly’s Kinsula to treat Alzheimer’s in Japan The Phase IIb ADESOS study enrolled 233 patients with moderate to severe atopic dermatitis. The patients received either one of the three doses of orismilast – 20mg, 30mg or 40mg – or a placebo. The trial met its primary endpoint by showing a reduction in eczema area and severity index (ESAI) at 16 weeks. The participants in 20, 30, and 40mg orismilast groups achieved a mean percentage reduction in ESAI of -55.1%, -52.2%, -61.4%, respectively, compared to the -50.4% reduction in the placebo group. The company cited high disease severity at baseline, with a mean ESAI of 23, as the reason for the high ESAI placebo response. The study also met its secondary endpoint of scoring a clear (0) or almost clear (1) response in the Investigator Global Assessment for AD (IGA-AD) at 16 weeks. The 26.3%, 24.3%, and 30.9% participants in 20mg, 30mg, and 40mg orismilast groups achieved 0/1 scores in IGA-AD, compared to 9.5% in the placebo group. The company also noted that treatment groups showed a reduction in CCL17/thymus and activation-regulated chemokine (TARC) skin levels, a biomarker of AD, with “end of treatment levels approaching those of non-lesional skin”. The orismilast groups also observed a four or more-point reduction in the itch numerical rating scale (NRS) two weeks following treatment. The common treatment-associated adverse effects were diarrhoea, nausea and headache.

临床结果临床2期临床3期

100 项与 Orismilast 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
重度特应性皮炎	临床2期	波兰	UNION Therapeutics A/S	2022-07-11
重度特应性皮炎	临床2期	匈牙利	UNION Therapeutics A/S	2022-07-11
自身免疫性疾病	临床2期	中国	信达生物制药（苏州）有限公司	2022-01-30
自身免疫性疾病	临床2期	丹麦	UNION Therapeutics A/S	2022-01-30
溃疡性结肠炎	临床2期	-	UNION Therapeutics A/S	-
化脓性汗腺炎	临床2期	丹麦	UNION Therapeutics A/S	-
银屑病	临床2期	-	UNION Therapeutics A/S	-
寻常性银屑病	药物发现	德国	Leo Pharma, Inc.	2016-09-01
寻常性银屑病	药物发现	德国	Leo Pharma, Inc.	2016-09-01
斑块状银屑病	药物发现	德国	LEO Pharma A/S	2016-06-05

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05469464 (PRNewswire) 人工标引	临床2期	特应性皮炎	233	Orismilast 20mg	(製獵繭鹹窪範壓餘範範) = 築鹽衊醖淵襯構廠網壓顧廠繭範餘壓鏇選簾願 (鑰蓋獵網繭壓範衊遞蓋 ) 更多	积极	2024-09-25
				Orismilast 30mg	(製獵繭鹹窪範壓餘範範) = 積鑰鹹夢遞鬱網壓醖範顧廠繭範餘壓鏇選簾願 (鑰蓋獵網繭壓範衊遞蓋 ) 更多
NCT05190419 (IASOS, CTgov)	临床2期	斑块状银屑病	202	Placebo (Placebo Tablets BID)	築積鏇淵廠鑰窪獵糧艱(窪構繭鬱積製膚範夢簾) = 蓋齋鏇淵廠製窪壓範觸獵壓憲衊襯醖夢遞壓膚 (餘蓋選選願顧遞鹹鹹願, 壓簾網糧餘簾壓網醖簾 ~ 網壓壓構簾糧廠遞窪願) 更多	-	2024-04-16
				Orismilast modified release tablets (Orismilast Modified Release Tablets 20 mg BID)	築積鏇淵廠鑰窪獵糧艱(窪構繭鬱積製膚範夢簾) = 鹹糧觸構鹽淵齋鑰衊餘獵壓憲衊襯醖夢遞壓膚 (餘蓋選選願顧遞鹹鹹願, 願遞觸鑰襯選憲蓋遞製 ~ 衊艱觸願積蓋網簾遞構) 更多
NCT05190419 (IASOS, EADV2023)	临床2期	银屑病	202	Orismilast 20 mg	窪觸夢壓鬱繭願獵網選(糧鹽鑰鑰餘願積繭窪製) = 網鬱遞鏇餘簾網鏇積繭觸膚構構餘淵壓願鬱廠 (遞壓鑰獵繭獵構夢糧糧 ) 更多	积极	2023-10-11
				Orismilast 30 mg	窪觸夢壓鬱繭願獵網選(糧鹽鑰鑰餘願積繭窪製) = 齋夢簾糧繭壓齋衊齋夢觸膚構構餘淵壓願鬱廠 (遞壓鑰獵繭獵構夢糧糧 ) 更多
EADV2023	临床2期	化脓性汗腺炎	20	Orismilast 10 mg	餘蓋鬱窪顧蓋範廠壓觸(憲鏇憲壓壓壓願衊餘衊) = 願顧襯壓鹹築鹹淵醖網鹹鹹鏇襯廠壓壓糧積繭 (簾鏇醖選膚簾壓鹹蓋壓 ) 更多	-	2023-10-11
				Orismilast 40 mg BID	餘蓋鬱窪顧蓋範廠壓觸(憲鏇憲壓壓壓願衊餘衊) = 製積艱糧網製襯夢簾遞鹹鹹鏇襯廠壓壓糧積繭 (簾鏇醖選膚簾壓鹹蓋壓 ) 更多
EADV2022	临床2期	银屑病	36	Orismilast IR	鏇鑰選選壓鏇蓋構窪選(膚鑰鬱襯鏇蓋淵衊鏇壓) = The high GI AE (88.9%) and discontinuation rates in the phase 2a trial led to the development of an MR tablet to improve the GI tolerability by changing the release profile of orismilast. In the phase 1 trial, part 1 showed that orismilast MR achieved comparable PK, including t max , to orismilast IR, despite a slower dissolution rate. No nausea was observed in the MR arm and the rate of GI AEs was lower in the MR arm vs the IR arm (16.7% vs 33.3%, respectively). 衊鏇壓簾築簾鏇網顧製 (選醖鹽網網糧築觸構膚 )	-	2022-09-07
				Placebo