A Multicenter, Phase 1b, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability, and the Efficacy of Si-544 in Adults With Psoriasis Vulgaris or Psoriatic Arthritis

The main objective of this study is to investigate the safety and tolerability of si-544.
Other objectives are to study the metabolism of si-544 in the body and to assess the effects of si-544 on cells of the body's immune system (immune cells) that have been chronically activated by the disease. Likewise, the effect of si-544 on inflammatory responses in the body triggered by the disease and other disease symptoms will be investigated.

开始日期2024-01-22

申办/合作机构

selectION, Inc.初创企业

[+1]

NCT05383378 / Completed临床1期

A Multi-center, Phase 1b, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2 sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.

开始日期2022-08-30

申办/合作机构

selectION, Inc.初创企业

[+1]

100 项与 SI-544 相关的临床结果

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100 项与 SI-544 相关的转化医学

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100 项与 SI-544 相关的专利（医药）

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项与 SI-544 相关的新闻（医药）

2024-05-28

·BioSpace

selectION Announces Initiation of Phase 1b Clinical Trial Evaluating si-544 in Patients with Psoriasis Vulgaris or Psoriatic Arthritis

New study follows completion of first-in-human Phase 1b trial in atopic dermatitis patients, in which selectION observed safety and tolerability of si-544 in the treatment of T cell autoimmunity Recruitment is underway, with topline results expected in 4Q24 selectION, Inc. (“selectION” or the “Company”), a clinical-stage biopharmaceutical company developing novel treatments for T cell-mediated autoimmune diseases, today announced the initiation of a Phase 1b trial with its lead compound si-544 in adult patients with psoriasis vulgaris (Ps) or psoriatic arthritis (PsA). si-544 is a selectivity-optimized peptide blocking the Kv1.3 ion channel. Kv1.3 is a key target in autoimmunity, which the Company believes has the potential to set a new standard for safety and tolerability in the treatment of T cell autoimmunity. Enrollment is ongoing and topline data are expected in the fourth quarter of 2024. This new clinical study is designed as a multicenter, Phase 1b, double-blind, placebo-controlled trial in adults with mild to severe Ps or PsA. The Company anticipates enrolling up to 40 patients with Ps, of which up to 16 patients may also have PsA. This psoriasis study follows the recent completion of the Company’s first-in-human Phase 1b trial in atopic dermatitis patients, in which the Company observed safety and tolerability of si-544 in adult patients with mild to severe atopic dermatitis. The current Phase 1b trial design in patients with Ps or PsA should also allow for the evaluation of efficacy signals. Patients will undergo a 4-week treatment period and a subsequent 12-week follow-up period. While the primary endpoints of the trial are safety and tolerability, secondary endpoints include the assessment of PD markers such as inflammatory cytokine levels. Andreas Klostermann, PhD, Chief Scientific Officer and co-founder of the Company said, “We are focused on expanding clinical development of si-544 in autoimmune indications, and we are looking forward to the results of this second, larger trial in a T cell-driven disorder.” Antonius Schuh, PhD, Chairman and CEO of selectION, Inc. added, “The promising data from our successful clinical study in atopic dermatitis patients provide further evidence that direct targeting of disease-associated, chronically activated T cells via Kv1.3 inhibition may provide effective and safe treatments for patients living with a broad variety of autoimmune diseases.” ### About selectION, Inc. selectION, Inc., is a clinical-stage biopharmaceutical company developing novel peptide therapies for autoimmune diseases and select cancer indications by targeting autoreactive, chronically activated T cells. The Company has established an efficient, unique technology platform to develop potent and highly selective peptide blockers for ion channels involved in various diseases. The platform enables systematically optimized target selectivity, providing the opportunity to develop drugs with significantly improved efficacy and safety pro selectION, Inc. is supported by SDL Ventures and Global Source Ventures. The Company is headquartered in San Diego, CA, USA, with a clinical R&D subsidiary in Munich/Martinsried, Germany. For further information, please visit About si-544 si-544, the Company´s lead drug candidate, is blocking Kv1.3, a specific ion channel involved in the activation and proliferation of TEM cells, with what the Company believes to be class leading selectivity. TEM cells lie at the root of many autoimmune indications such as atopic dermatitis, psoriasis, rheumatoid arthritis, or multiple sclerosis, but also of certain rare cancers like lymphomas. si-544 has demonstrated what the Company believes is an excellent safety and tolerability pro a recently completed Phase 1b clinical trial in atopic dermatitis patients, with study results also indicating an initial efficacy signal. Previously, si-544 has demonstrated what the Company believes is excellent efficacy in animal and human T cell models. The compound is a potent immuno-selective agent addressing a significant unmet medical need by functionally inhibiting and eliminating disease-specific, chronically activated TEM cells while maintaining full immunocompetence. Forward Looking Statements This press release includes forward-looking statements related to selectION, Inc. (the “Company”), including statements regarding the prospects of si-544 and the value of the phase 1b trial evaluating si-544 in patients with atopic dermatitis (the “Trial”). These forward-looking statements are based upon information that is currently available to the Company and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that the Company does not realize the expected benefits of si-544 or the Trial; risks that the results of the Trial may not be accurate; risks that prior clinical trial results may not be repeated; and general economic and market factors. Any of these may cause the Company’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by the Company’s forward-looking statements. The Company expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. Contacts Media Contact: akampion Dr. Ludger Wess / Ines-Regina Buth Managing Partners info@akampion.com T: +49 40 88 16 59 64 / T: +49 30 23 63 27 68 Investor Contact: selectION, Inc. Steve Zaniboni Chief Financial Officer szaniboni@selectiontherapeutics.com T: +1 858 967 8014

临床1期

2024-05-08

·药明康德

维持阿尔茨海默病患者认知功能超过3年的靶向疗法；无需打针，多款疫苗临床进展积极…… | 一周盘点

▎药明康德内容团队编辑本期看点1. 治疗特应性皮炎的选择性肽疗法si-544的1b期临床试验结果积极，75%的患者的临床症状有客观改善。2. 下一代精准靶向疗法XPro使两名阿尔茨海默病患者的认知功能保持稳定超过3年。3. 美国FDA批准了在研先导编辑（prime editing）疗法PM359用于治疗慢性肉芽肿病（CGD）的IND申请，标志新一代基因编辑技术临床转化的重要里程碑。药明康德内容团队整理si-544：公布1b期临床试验数据selectION公司公布了其候选药物si-544在轻度至重度特应性皮炎患者中的1b期临床试验数据。si-544是一种选择性经优化的多肽疗法，可阻断离子通道Kv1.3。Kv1.3是一种参与效应记忆T（TEM）细胞激活和增殖的特殊离子通道。TEM细胞是许多自身免疫性疾病（如特应性皮炎、银屑病、类风湿性关节炎或多发性硬化）及某些罕见癌症（如淋巴瘤）的根源。在临床前研究中，si-544表现出了良好的疗效。该候选疗法通过在功能上抑制和消除疾病特异性、慢性激活的TEM细胞，同时保持完全的免疫能力，有望解决重大的未竟医疗需求。此次公布的结果显示，si-544的耐受性良好，没有观察到严重的不良反应、剂量限制毒性或安全信号。在接受si-544治疗的患者中，75%的患者的临床症状得到了客观改善，其中44%的患者在监测期结束时，皮肤变得光洁或接近光洁。用药后，这种改善的趋势维持了整个监测期。XPro：公布1b期临床试验中两名患者的数据INmune Bio公司公布了两名在完成1b期试验后继续接受XPro治疗超过3年的阿尔茨海默病患者的最新情况。XPro是一款旨在中和可溶性肿瘤坏死因子（TNF）的下一代精准靶向疗法。该候选疗法不会干扰促进正常功能和修复的TNF形式，这种特异性大大提高了有效性和安全性。两名阿尔茨海默病患者在完成为期3个月的开放标签试验和12个月的扩展试验后，在澳大利亚同情使用计划下继续接受XPro治疗超过三年。此次公布的结果显示，XPro长期给药的安全性和耐受性良好，这些患者已在持续的XPro治疗中保持稳定的认知功能超过3年。PM359：IND申请获得FDA许可Prime Medicine公司宣布，该公司为在研先导编辑疗法PM359递交的IND申请已经获得美国FDA的许可，用于治疗慢性肉芽肿病。这使该公司能够启动全球性的1/2期临床试验。新闻稿指出，这是先导编辑技术首个获得许可的IND，标着新一代基因编辑技术临床转化的重要里程碑。PM359是Prime Medicine在血液学和免疫学领域的首个候选疗法，针对的是慢性肉芽肿病的p47phox变体。PM359通过先导编辑器在体外修改自体造血干细胞（HSCs）。临床前研究显示，这些编辑器可以高效率纠正携带病因突变细胞的DNA。PM359已获得美国FDA授予的罕见儿科药物认定和孤儿药资格。二价诺如病毒候选疫苗：公布1期临床试验数据Vaxart公司公布了其口服二价诺如病毒候选疫苗片剂的1期临床试验的顶线结果。该候选疫苗的使用对象是处于哺乳期的母亲，旨在通过母乳将诺如病毒抗体从母体转移到婴儿，从而潜在地提高婴儿对诺如病毒感染的抵抗力。研究人员在这项研究中观察到哺乳期的母亲及其母乳中的抗体升高。在高剂量组母亲的母乳中，针对诺如病毒GI.1病毒株的抗体平均升高了4.0倍，针对GII.4病毒株的抗体平均升高6.0倍。安全性方面，没有出现与疫苗相关的严重不良事件，也没有出现剂量限制性药理毒性。LTI-03：公布1b期临床试验的初步数据Aileron Therapeutics公司公布了其用于治疗特发性肺纤维化（IPF）吸入性疗法LTI-03的1b期临床试验数据。LTI-03是一种新型的Caveolin-1相关多肽，由7个氨基酸组成，可抑制促纤维化信号传导并帮助关键上皮细胞存活。此次公布的结果显示，LTI-03低剂量组患者在接受治疗后，病理性基底样细胞和成纤维细胞中多种促纤维化蛋白的表达降低，与上皮健康相关生物标志物的表达增加。作为评估指标的8种生物标志物中，有7种表现出了积极趋势，其中3种具有统计学意义。安全性方面，低剂量LTI-03的耐受性良好，未观察到安全信号。LTI-03高剂量组的数据预计将于2024年第三季度公布。REM-422：两项1期临床试验完成首批患者给药Remix Therapeutics公司宣布，其潜在“first-in-class”的MYB mRNA降解剂REM-422的两项1期临床试验均已完成首批患者给药。MYB是多种实体瘤和血液恶性肿瘤的致癌驱动因子。REM-422是一种强效、选择性口服小分子mRNA降解剂，通过促进mRNA转录本掺入毒性外显子，引发无义介导的mRNA降解（NMD），可减少MYB mRNA及随后的蛋白表达，从而在MYB依赖性人类肿瘤模型中产生抗肿瘤活性。目前，REM-422正在一项针对复发或转移性腺样囊性癌（ACC）患者的1期临床试验和一项针对复发/难治性急性髓系白血病（AML）或高危骨髓增生异常综合征（MDS）患者的1期临床试验中接受评估。该公司还宣布，美国FDA授予了REM-422孤儿药资格，用于治疗ACC和AML。SNK01：IND申请获得FDA许可NKGen Biotech公司宣布，美国FDA已批准其在研自然杀伤（NK）细胞疗法SNK01用于治疗帕金森病的IND申请。SNK01是一款自体、非基因工程改造的NK细胞产品。它具有增强的细胞毒性和激活性受体的表达，有望成为治疗帕金森病的一种新方法。该公司预计将于2024年下半年启动针对帕金森病的1期临床试验。PRAME TCR/IL-15 NK（SY-307）：IND申请获得FDA许可Replay公司和MD安德森癌症中心共同宣布，美国FDA已批准PRAME TCR/IL-15 NK（SY-307）的IND申请。PRAME TCR/IL-15 NK（SY-307）是一种由脐带血NK细胞开发而成的，用于治疗复发/难治性髓系恶性肿瘤的工程化T细胞受体（TCR）NK细胞疗法。这些细胞表达针对PRAME肿瘤相关新抗原的高亲和力TCR。PRAME具高免疫原性，在多种不同类型的癌症中都有表达，包括AML和MDS等血液系统恶性肿瘤，以及黑色素瘤、肉瘤、卵巢癌、子宫内膜癌、肺癌和乳腺癌等实体瘤。该候选疗法用于治疗复发/难治性AML和MDS患者的1/2期研究预计将于2024年第三季度启动。INNA-051：IND申请获得FDA许可ENA Respiratory公司宣布，美国FDA已批准其新型toll样受体2/6（TLR2/6）激动剂INNA-051干粉制剂的IND申请。INNA-051是一种不受病毒类型限制的鼻内抗病毒宿主防御免疫调节剂，是TLR2/6的强效潜在“first-in-class”激动剂。TLR2/6在识别病原体和触发先天性免疫反应中发挥着关键作用。此前，ENA Respiratory公司在流感模型中进行的2a期研究结果表明，INNA-051液体制剂能加速病毒清除并局部激发宿主的抗病毒防御能力。在此基础上，该公司开发了改进的干粉制剂，旨在为呼吸道病毒感染高危人群（包括老年人、患有基础疾病的人和有职业风险的人）提供一种方便的、每周仅需使用一次的鼻腔给药产品，以预防与呼吸道病毒感染相关的并发症。▲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（可上下滑动查看）[1] selectION Announces Positive Results from Phase 1b Clinical Trial Evaluating si-544 in Patients with Atopic Dermatitis. Retrieved April 30, 2024, from https://www.globenewswire.com/news-release/2024/04/29/2870968/0/en/selectION-Announces-Positive-Results-from-Phase-1b-Clinical-Trial-Evaluating-si-544-in-Patients-with-Atopic-Dermatitis.html[2] ENA Respiratory Announces FDA IND Clearance for its Prophylactic Intranasal INNA-051 - a First-in-Class Antiviral Innate Immunomodulator. Retrieved April 30, 2024, from https://www.globenewswire.com/news-release/2024/04/29/2870969/0/en/ENA-Respiratory-Announces-FDA-IND-Clearance-for-its-Prophylactic-Intranasal-INNA-051-a-First-in-Class-Antiviral-Innate-Immunomodulator.html[3] Prime Medicine Announces FDA Clearance of Investigational New Drug (IND) Application for PM359 for the Treatment of Chronic Granulomatous Disease (CGD). Retrieved April 30, 2024, from https://www.globenewswire.com/news-release/2024/04/29/2871079/0/en/Prime-Medicine-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-PM359-for-the-Treatment-of-Chronic-Granulomatous-Disease-CGD.html[4] Replay[5] Terns Pharmaceuticals Announces Data from Ongoing Phase 1 Pharmacokinetic Study of Allosteric BCR-ABL Inhibitor TERN-701 in Adult Healthy Volunteers and Highlights Potential for Competitive Differentiation. Retrieved April 30, 2024, from https://www.globenewswire.com/news-release/2024/04/29/2871639/0/en/Terns-Pharmaceuticals-Announces-Data-from-Ongoing-Phase-1-Pharmacokinetic-Study-of-Allosteric-BCR-ABL-Inhibitor-TERN-701-in-Adult-Healthy-Volunteers-and-Highlights-Potential-for-Co.html[6] Bitterroot Bio Announces Dosing of First Participants in a Phase 1, First-in-Human Study of BRB-002 in Healthy Volunteers. Retrieved April 30, 2024, from https://www.globenewswire.com/news-release/2024/04/29/2871160/0/en/Bitterroot-Bio-Announces-Dosing-of-First-Participants-in-a-Phase-1-First-in-Human-Study-of-BRB-002-in-Healthy-Volunteers.html[7] Replay and MD Anderson announce FDA clearance of IND application for first-in-class PRAME-targeted T-Cell Receptor Natural Killer (TCR-NK) cell therapy for hematological malignancies. Retrieved April 30, 2024, from https://www.globenewswire.com/news-release/2024/04/30/2872029/0/en/Replay-and-MD-Anderson-announce-FDA-clearance-of-IND-application-for-first-in-class-PRAME-targeted-T-Cell-Receptor-Natural-Killer-TCR-NK-cell-therapy-for-hematological-malignancies.html[8] Aileron Therapeutics Announces Positive Data from Cohort 1 of the Phase 1b Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis (IPF). Retrieved May 1, 2024, from https://www.globenewswire.com/news-release/2024/05/01/2873251/28652/en/Aileron-Therapeutics-Announces-Positive-Data-from-Cohort-1-of-the-Phase-1b-Clinical-Trial-of-LTI-03-in-Idiopathic-Pulmonary-Fibrosis-IPF.html[9] Context Therapeutics Announces FDA Clearance of IND Application for a Phase 1 Clinical Trial of CTIM-76. Retrieved May 6, 2024, from https://www.globenewswire.com/news-release/2024/05/02/2874098/0/en/Context-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-a-Phase-1-Clinical-Trial-of-CTIM-76.html[10] Ventus Therapeutics Announces First Participant Dosed in Clinical Study with an NLRP3 Inhibitor Licensed Exclusively to Novo Nordisk. Retrieved May 6, 2024, from https://www.businesswire.com/news/home/20240430835089/en[11] Arsenal Biosciences Announces First Patient Dosed in Phase 1/2 Clinical Trial of AB-2100 in Development as a Treatment for Clear-cell Renal Cell Carcinoma. Retrieved May 6, 2024, from https://www.businesswire.com/news/home/20240430131934/en/[12] Foresee Pharmaceuticals Announces First Subject Dosed in its First-in-Human Clinical Trial of FP-020. Retrieved May 6, 2024, from https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-first-subject-dosed-in-its-first-in-human-clinical-trial-of-fp-020-302131320.html[13] Aurion Biotech Announces Completion of Enrollment in Phase 1 / 2 Clinical Trial. Retrieved May 6, 2024, from https://www.businesswire.com/news/home/20240430312515/en[14] Alumis Announces First Participant Dosed in Phase 1 Clinical Trial of CNS Penetrant Allosteric TYK2 Inhibitor A-005. Retrieved May 6, 2024, from https://www.globenewswire.com/en/news-release/2024/04/30/2872215/0/en/Alumis-Announces-First-Participant-Dosed-in-Phase-1-Clinical-Trial-of-CNS-Penetrant-Allosteric-TYK2-Inhibitor-A-005.html[15] Debiopharm & Repare Therapeutics Announce First Patient Dosed in Phase 1/1b Mythic Trial Evaluating the Synthetic Lethal Combination of WEE1 AND PKMYT1 Inhibition. Retrieved May 6, 2024, from https://www.businesswire.com/news/home/20240430915822/en[16] IRLAB has Received Approval from the Swedish Medical Products Agency to Conduct a Phase I Study of the Drug Candidate IRL757. Retrieved May 6, 2024, from https://irlab.se/mfn_news/irlab-has-received-approval-from-the-swedish-medical-products-agency-to-conduct-a-phase-i-study-of-the-drug-candidate-irl757/[17] Remix Therapeutics Announces First Patients Dosed in Two Phase 1 Clinical Trials Investigating REM-422 for Treatment of Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS). Retrieved May 6, 2024, from https://www.prnewswire.com/news-releases/remix-therapeutics-announces-first-patients-dosed-in-two-phase-1-clinical-trials-investigating-rem-422-for-treatment-of-adenoid-cystic-carcinoma-acc-and-acute-myeloid-leukemiamyelodysplastic-syndromes-amlmds-302133787.html[18] INmune Bio Inc. Provides Update on Two Patients from the Phase 1b Alzheimer’s Disease Trial who Continue to Receive XPro™ Under Compassionate Use for Over Three Years. Retrieved May 6, 2024, from https://www.inmunebio.com/index.php/newsroom/2024-news/muneioncrovidespdateonwoatientsfromtheha20240430050503[19] Vaxart Announces Positive Results for Its Bivalent Norovirus Vaccine Candidate in Lactating Mothers. Retrieved May 6, 2024, from https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-positive-results-its-bivalent-norovirus-vaccine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

临床申请临床2期临床1期疫苗临床结果

2024-03-06

·Business Wire

Global Psoriatic Arthritis Drug Landscape Research Report 2024: Comprehensive Insights About 20+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Psoriatic Arthritis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Psoriatic Arthritis pipeline landscape is provided which includes the disease overview and Psoriatic Arthritis treatment guidelines. The assessment part of the report embraces, in depth Psoriatic Arthritis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Psoriatic Arthritis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Psoriatic Arthritis R&D. The therapies under development are focused on novel approaches to treat/improve Psoriatic Arthritis. Psoriatic Arthritis Emerging Drugs Chapters This segment of the Psoriatic Arthritis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Psoriatic Arthritis Emerging Drugs Sotyktu: Bristol Myers Squibb Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3. Currently, the drug is in the Phase III stage of its development for the treatment of Psoriasis Arthritis. HS-10374: Hansoh BioMedical R&D Company HS-10374 mechanism of action is to inhibit (TYK2) that is tyrosine-kinase 2. TYK2 inhibitors work by blocking the TYK2 protein and the cellular signals that run through it. Those signals can in turn activate other immune proteins and are associated with inflammation. Its route of administration is orally. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Psoriasis Arthritis. si-544: selection si-544, the Companys lead candidate, selectively blocks Kv1.3, a key ion channel expressed disease-associated effector memory T (TEM) cells. Kv1.3 is essential for the chronic activation and proliferation of these cells which escape the control of the immune system and become malignant. TEM cells drive inflammation in many autoimmune diseases, including atopic dermatitis, psoriasis, rheumatoid arthritis, and multiple sclerosis. Currently, the drug is in the Phase I stage of its development for the treatment of Psoriasis Arthritis. Psoriatic Arthritis: Therapeutic Assessment Major Players in Psoriatic Arthritis There are approx. 20+ key companies which are developing the therapies for Psoriatic Arthritis. The companies which have their Psoriatic Arthritis drug candidates in the most advanced stage, i.e. Phase III include, Bristol Myers Squibb. Phases The report covers around 25+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Psoriatic Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Psoriatic Arthritis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Psoriatic Arthritis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Psoriatic Arthritis drugs. Psoriatic Arthritis Report Insights Psoriatic Arthritis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Psoriatic Arthritis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Pfizer selectION Therapeutics GmbH Jiangsu HengRui Medicine Co., Ltd. Nimbus Lakshmi, Inc. Hansoh BioMedical R&D Company Bio-Thera Solutions Mylan Inc. ACELYRIN Inc. Key Products PF-06700841 si-544 SHR0302 NDI-034858 HS-10374 BAT2506 MYL-1401A ABY-035 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/v6c9p4 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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适应症	最高研发状态	国家/地区	公司	日期
银屑病关节炎	临床1期	德国	selectION, Inc.初创企业	2024-01-22
寻常性银屑病	临床1期	德国	selectION, Inc.初创企业	2024-01-22
特应性皮炎	临床1期	德国	selectION, Inc.初创企业	2022-08-30
皮肤T细胞淋巴瘤	临床前	美国	selectION, Inc.初创企业	-
皮肤T细胞淋巴瘤	临床前	德国	selectION, Inc.初创企业	-