A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase.
The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies.
The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.

开始日期2024-09-01

申办/合作机构

Abivax SA

CTR20232947 / Recruiting临床3期

一项在中度至重度活动性溃疡性结肠炎受试者中评价ABX464每日一次诱导治疗的有效性和安全性的随机、双盲、安慰剂对照、多中心、3期研究

主要目的是比较ABX464与安慰剂在临床缓解方面的有效性。

开始日期2024-03-12

申办/合作机构

Creapharm Clinical Supplies SAS

[+3]

CTRI/2023/05/053075 / Recruiting临床3期

A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis. – ABTECT Maintenance - ABTECT Maintenance

开始日期2023-09-29

申办/合作机构

Abivax SA

[+1]

100 项与 Obefazimod 相关的临床结果

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100 项与 Obefazimod 相关的转化医学

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100 项与 Obefazimod 相关的专利（医药）

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项与 Obefazimod 相关的文献（医药）

2024-04-01·International journal for parasitology. Drugs and drug resistance

Structure-activity relationship and target investigation of 2-aryl quinolines with nematocidal activity

Article

作者: Hofmann, Andreas ; Korhonen, Pasi K ; Chang, Bill C H ; Wells, Tim N C ; Byrne, Joseph J ; Jabbar, Abdul ; Williamson, Nicholas ; Leeming, Michael G ; Wang, Tao ; Young, Neil D ; Keiser, Jennifer ; Zheng, Yuanting ; Taki, Aya C ; Nguyen, Nghi ; Shanley, Harrison T ; Nie, Shuai ; Gasser, Robin B ; Häberli, Cécile ; Ang, Ching-Seng ; Sleebs, Brad E

Within the context of our anthelmintic discovery program, we recently identified and evaluated a quinoline derivative, called ABX464 or obefazimod, as a nematocidal candidate; synthesised a series of analogues which were assessed for activity against the free-living nematode Caenorhabditis elegans; and predicted compound-target relationships by thermal proteome profiling (TPP) and in silico docking. Here, we logically extended this work and critically evaluated the anthelmintic activity of ABX464 analogues on Haemonchus contortus (barber's pole worm) - a highly pathogenic nematode of ruminant livestock. First, we tested a series of 44 analogues on H. contortus (larvae and adults) to investigate the nematocidal pharmacophore of ABX464, and identified one compound with greater potency than the parent compound and showed moderate activity against a select number of other parasitic nematodes (including Ancylostoma, Heligmosomoides and Strongyloides species). Using TPP and in silico modelling studies, we predicted protein HCON_00074590 (a predicted aldo-keto reductase) as a target candidate for ABX464 in H. contortus. Future work aims to optimise this compound as a nematocidal candidate and investigate its pharmacokinetic properties. Overall, this study presents a first step toward the development of a new nematocide.

2024-01-01·Bioorganic & medicinal chemistry

Structure activity relationship and target prediction for ABX464 analogues in Caenorhabditis elegans

Article

作者: Hofmann, Andreas ; Wells, Tim N C ; Korhonen, Pasi K ; Byrne, Joseph J ; Williamson, Nicholas ; Leeming, Michael G ; Jabbar, Abdul ; Gasser, Robin B ; Wang, Tao ; Young, Neil D ; Zheng, Yuanting ; Nguyen, Nghi ; Taki, Aya C ; Shanley, Harrison T ; Nie, Shuai ; Sleebs, Brad E ; Ang, Ching-Seng

Global challenges with treatment failures and/or widespread resistance in parasitic worms against commercially available anthelmintics lend impetus to the development of new anthelmintics with novel mechanism(s) of action. The free-living nematode Caenorhabditis elegans is an important model organism used for drug discovery, including the screening and structure-activity investigation of new compounds, and target deconvolution. Previously, we conducted a whole-organism phenotypic screen of the 'Pandemic Response Box' (from Medicines for Malaria Venture, MMV) and identified a hit compound, called ABX464, with activity against C. elegans and a related, parasitic nematode, Haemonchus contortus. Here, we tested a series of 44 synthesized analogues to explore the pharmacophore of activity on C. elegans and revealed five compounds whose potency was similar or greater than that of ABX464, but which were not toxic to human hepatoma (HepG2) cells. Subsequently, we employed thermal proteome profiling (TPP), protein structure prediction and an in silico-docking algorithm to predict ABX464-target candidates. Taken together, the findings from this study contribute significantly to the early-stage drug discovery of a new nematocide based on ABX464. Future work is aimed at validating the ABX464-protein interactions identified here, and at assessing ABX464 and associated analogues against a panel of parasitic nematodes, towards developing a new anthelmintic with a mechanism of action that is distinct from any of the compounds currently-available commercially.

2023-11-08·Journal of Crohn's & colitis

Obefazimod: A First-in-class Drug for the Treatment of Ulcerative Colitis

Article

作者: Scherrer, Didier ; d'Agay, Laurence ; Tilg, Herbert ; Gineste, Paul ; Danese, Silvio ; Vermeire, Séverine ; Peyrin-Biroulet, Laurent ; Solitano, Virginia ; Ehrlich, Hartmut ; Sands, Bruce E

Abstract:

Biologic agents and oral small molecules are the mainstays of inflammatory bowel disease [IBD] management. However, an unmet clinical need remains for additional agents with novel mechanism of action which are effective, safe, and disease-modifying; this is due to the substantial proportion of patients who do not respond, lose response, or develop intolerance to currently marketed products. microRNAs [miRNAs] that play a role in the modulation of signal transduction pathways implicated in the development of IBD hold the potential to be used as therapeutic targets. Recently, a novel first-in-class compound, obefazimod, originally conceived as a human immunodeficiency virus [HIV] infection drug, has shown great promise in phase II induction trials for ulcerative colitis [UC] patients. Findings from the maintenance phases of trials showed that long-term obefazimod treatment provides continued improvement in clinical symptoms of disease, with a substantial proportion of patients in clinical remission, and an overall good safety profile. With a novel mechanism of action, obefazimod is an orally available small molecule with anti-inflammatory properties through the specific and selective upregulation of miR-124 expression. The aim of this paper is to critically review the available evidence related to pharmacokinetics and pharmacodynamics, and to discuss the potential clinical implications of this first-in-class oral small molecule.

项与 Obefazimod 相关的新闻（医药）

2024-06-23

·药渡

欧洲杯来了！哪些国家最有望夺得“最佳药物管道”奖杯？

来源：药渡撰文：Maskey 编辑：哦呼欧洲杯激战正酣，各国球队为了荣誉和胜利而奋力拼搏。但如果换个角度，设想一下，若是让这些参加欧洲杯的国家在“最佳药物管道”这一特殊领域展开角逐，谁又将脱颖而出，问鼎桂冠呢？目前，世界各地的制药公司都在竞相开发最具创新性和最有效的常见人类疾病治疗方法。他们进行临床前研究和临床试验，希望他们的治疗方法能得到监管机构的批准。监管机构会为可能治疗严重疾病的新型试验药物授予突破性疗法认定和快速通道认定。近年来，越来越多的新型治疗方法（如细胞和基因疗法、单克隆抗体和抗体-药物偶联物）已获得监管机构的批准[1]。因此，制药公司正在加大对这些创新疗法的开发投入。一些最大的制药公司位于欧洲，所有这些公司都在建立庞大的创新疗法药物管线。图1.近年来美国食品药品监督管理局(FDA)批准的新分子实体（NME）和生物制剂的数量【1】图2.获得批准的单克隆抗体百分比【2】德国拜耳是德国领先的制药公司之一。老年性黄斑变性药物阿柏西普、前列腺癌药物达罗他胺、抗凝药物利伐沙班和慢性肾病药物Finerenone是其产品组合中最有价值的药物。该公司正在开发33种新疗法，其中19种疗法正在进行1期临床试验，3种疗法正在进行2期临床试验[3]。该公司正在测试几种创新的重组腺相关病毒 (rAAV) 基因疗法，用于治疗亨廷顿氏病、帕金森氏病和庞贝氏病。另一家德国制药公司勃林格殷格翰正在临床试验中测试40多种药物[4]。该公司已经开发出用于治疗多种疾病的小分子药物、T细胞接合剂和癌症疫苗。该公司的产品组合中包括有效的治疗药物，包括肺纤维化药物尼达尼布和抗糖尿病药物恩格列净。默克集团是另一家德国制药公司，正在开发10多种用于治疗癌症、自身免疫性疾病和疟疾的药物[5]。其药物管线中一些有前景的在研药物包括小分子药物Enpatoran、抗体药物偶联物M9140和免疫检查点抑制剂avelumab。 BioNtech也是一家德国大型生物制药公司，与辉瑞公司成功开发了COVID-19疫苗BNT162b2(Comirnaty)。该公司还在对患有不同类型癌症（如结直肠癌和胰腺导管腺癌）的患者测试癌症疫苗Autogene Cevumeran[6]。BioNTech SE正在临床试验中测试30多种治疗方法，包括mRNA治疗、细胞疗法、基于蛋白质的疗法和小分子免疫调节剂。这些治疗方法旨在治疗癌症和传染病。其管道中最有前途的候选药物之一是单克隆抗体Gotistobart，正在非小细胞肺癌患者中进行测试。该公司开发的其他重要药物包括双特异性抗体Acasunlimab、BNT312/GEN1042和BNT327/PM8002。德国规模较小的生物制药公司也在努力扩大其药物研发线。Ethris开发了一种新型吸入式mRNA治疗药物ETH47，用于治疗呼吸道病毒感染。海德堡制药公司研发线中的一种主要候选药物是用于治疗多发性骨髓瘤的抗体-药物偶联物HDP-101。Affimed开发了用于治疗非小细胞肺癌的双特异性先天细胞接合剂AFM24。Atai Life Sciences研发线中有几种用于治疗抑郁症和焦虑症的药物。法国法国最大的制药公司赛诺菲拥有庞大的药物管线，包括60多种临床阶段治疗药物[7]。该公司正在开发双特异性抗体、疫苗、单克隆抗体、NK细胞接合剂、酶替代疗法和基因疗法。其最畅销的药物是与Regeneron合作开发的单克隆抗体度匹鲁单抗。该药物已被批准用于多种适应症，例如特应性皮炎、嗜酸性食管炎和哮喘。其投资组合中的另一项重要资产是与阿斯利康合作开发的呼吸道合胞病毒 (RSV) 疫苗nirsevimab。其管线中的几种药物，如小分子药物SAR441566、单克隆抗体Amlitelimab和单克隆抗体Frexalimab，都有可能获得监管部门的批准并成为变革性的治疗方法。法国还有几家不太知名的制药公司，包括Genfit、Abivax和Enterome，它们正在研发新的创新疗法。Genfit正在开发治疗胆管癌和高氨血症的新疗法。今年6月，FDA加速批准其药物Elafibranor，用于治疗原发性胆汁性胆管炎。Amolyt Pharma的药物管线包括治疗肢端肥大症和甲状旁腺功能减退症的药物。Enterome正在开发新的基于肽的免疫疗法，用于治疗惰性非霍奇金淋巴瘤和胶质母细胞瘤。Abivax已开发小分子药物obefazimod，用于治疗溃疡性结肠炎和克罗恩病。Antabio正在开发治疗铜绿假单胞菌感染和医院内感染的药物。Ipen的临床阶段管线中有10多种药物，包括治疗偏头痛、阿拉吉耶综合征、多发性骨髓瘤和胆道闭锁的药物[8]。英国英国-瑞典制药公司阿斯利康拥有最大的药物管线之一，拥有超过90种不同的临床阶段治疗药物[9]。该公司正在开发用于治疗癌症、呼吸系统疾病、代谢疾病、肾脏疾病和心血管疾病的新药。它拥有非常强大的肿瘤学产品组合，包括抗体药物偶联物trastuzumab deruxtecan和酪氨酸激酶抑制剂奥希替尼。该公司还通过购买和公司收购在其管线中增加了嵌合抗原受体T细胞(CAR-T)疗法、呼吸道合胞病毒疫苗和2型糖尿病药物。其与第一三共联合开发的抗体药物偶联物Datopotamab deruxtecan可能很快会在美国获得监管部门的批准。葛兰素史克 (GSK) 已开发出60多种用于治疗艾滋病毒、癌症、传染病以及呼吸道和免疫疾病的药物。该公司最近开发的最成功的治疗方法之一是呼吸道合胞病毒疫苗Arexvy，该疫苗已获得FDA批准用于50岁以上的人群[10]。该公司在开发高效疫苗方面有着良好的记录，例如Gardasil、Arexvy和 Shingrix。今年，GSK收购了一家新兴生物制药公司Aiolos Bio，该公司开发了一种新型哮喘药物。 Verona Pharma开发了一种用于治疗慢性阻塞性肺病的药物Ensifentrine，今年可能会获得FDA的批准。Ellipses Pharma正在对2期临床试验中的四种药物进行评估[11]。该公司正在研发不同类别的药物，例如用于治疗癌症的双重抑制剂、纳米颗粒-药物偶联物和选择性雄激素受体调节剂 (SARM)。Evox Therapeutics正在临床前研究中开发外泌体递送的腺相关病毒(AAV) 基因疗法，用于治疗苯丙酮尿症和心血管疾病[12]。瑞士罗氏的研发管线中有70多种药物[13]。该公司开发的转化疗法之一是双特异性单克隆抗体Faricimab，用于治疗糖尿病性黄斑水肿和新生血管性年龄相关性黄斑变性。其他成功获得监管部门批准的重要治疗方法是抗体-药物偶联物polatuzumab vedotin-piiq双特异性单克隆抗体Emicizumab和双特异性抗体glofitamab-gxbm。其阿尔茨海默氏症药物gantenerumab在3期临床试验中未能显示出疗效。该公司已将小分子抑制剂camonsertib和双特异性抗体RG6286等抗癌药物从其管线中移除。罗氏正在优先考虑那些更有可能获得监管机构批准的治疗方法。诺华是全球销售额最大的制药公司之一。其药物研发管线中有超过60种治疗方法[14]。其研发管线包括单克隆抗体、CAR-T疗法、基因疗法、小分子抑制剂、合成小干扰RNA (siRNA) 和其他治疗不同疾病的药物。其产品组合中的重要资产是心力衰竭组合药物Sacubitril/valsartan、多发性硬化症药物 Ofatumumab、乳腺癌药物ribociclib和高脂血症药物inclisiran。其布鲁顿氏酪氨酸激酶(BTK)抑制剂remibrutinib很有可能被批准用于治疗慢性自发性荨麻疹。 ADC Therapeutics正在临床试验中测试大约3种治疗方法[14]。该公司开发了抗体药物偶联物loncastuximab tesirine-lpyl，该药物已获得FDA加速批准，用于治疗大B细胞淋巴瘤。Alentis Therapeutics的研发管线中有大约4种治疗方法，包括抗体药物偶联物和单克隆抗体[15]。图3.销售额最高的制药公司和治疗方法【16】丹麦丹麦制药公司诺和诺德是欧洲最大的制药公司之一。诺和诺德的药物管线包括35多种药物，其中大多数药物正在对患有非酒精性脂肪性肝炎和糖尿病等慢性疾病的患者进行测试[17]。其最成功的药物是用于治疗肥胖症和糖尿病的索马鲁肽。诺和诺德开发了一种每周一次的糖尿病药物胰岛素Icodec，该药物已获准在欧洲使用。Genmab有10多种治疗方法正在临床试验中测试。它与辉瑞联合开发了抗体-药物偶联物tisotumab vedotin，该药物已获准用于治疗宫颈癌。其T细胞结合双特异性抗体epcoritamab也已获准用于治疗弥漫性大B细胞淋巴瘤。比利时比利时生物制药公司Union Chimique Belge (UCB)正在开发用于治疗系统性红斑狼疮和严重纤维肌痛综合征等神经和自身免疫性疾病的药物。其研发管线中有大约10种小分子药物和单克隆抗体[18]。其药物bimekizumab已在美国获批用于治疗斑块状银屑病。荷兰荷兰制药公司Argenx开发了抗体片段efgartigimod，该片段已获批用于治疗全身性重症肌无力。该公司正在对患有干燥综合征和特发性炎症性肌病的患者进行efgartigimod测试。该公司正在研发的另一种药物是单克隆抗体Empasiprubart，该药物已被开发用于治疗多灶性运动神经病。总之，欧洲几家大型制药公司正在开发用于多种疾病的一流和一流药物。这些公司通过研究、收购和与其他公司的联合合作建立了强大的药物管线。在这些欧洲国家中，德国、英国、瑞士和法国都有成熟和新兴的生物制药公司，专注于开发创新疗法。大多数公司都开发出了有效的治疗方法，并已在许多国家获准使用。编者按：在这场假想的“最佳药物管道”欧洲杯中，每个国家都有机会展现自己的实力和风采，我们都期待看到其在“赛场”上展现出最佳的状态。未来我们应给予各国更多在医药研究上付出与收获的关注，以及他们为全人类的健康福祉所作出的杰出贡献。参考文献（可上下滑动）： [1] Senior, M. (2023). Fresh from the biotech pipeline: fewer approvals, but biologics gain share. nature biotechnology, 41(2), 174. [2] Walsh, G., & Walsh, E. (2022). Biopharmaceutical benchmarks 2022. Nature Biotechnology, 40(12), 1722-1760. [3] Bayer (2024, 30 April ). Pharmaceuticals Pipeline Overview and Progress. https://www.bayer.com/sites/default/files/ph-rd-pipeline-2024-05-final-1.pdf [4] Boehringer Ingelheim (n.d.). Boehringer Ingelheim Human Pharma Clinical Pipeline. https://www.boehringer-ingelheim.com/bipdf/pipeline-february-2024 [5] Merck Group (n.d.). HEALTHCARE PIPELINE. https://www.merckgroup.com/en/research/healthcare-pipeline.html [6] BioNTech SE (2024, 7 April). Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer. https://investors.biontech.de/news-releases/news-release-details/three-year-phase-1-follow-data-mrna-based-individualized [7] Sanofi (n.d.). Our Pipeline. https://www.sanofi.com/en/our-science/our-pipeline [8] Ipsen (n.d.). Pipeline. https://www.ipsen.com/pipeline/ [9] AstraZeneca (n.d.). Our pipeline. https://www.astrazeneca.com/our-therapy-areas/pipeline.html#cvrm [10] GSK. (2024, 7 June). US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-expanded-age-indication-for-gsk-s-arexvy-the-first-rsv-vaccine-for-adults-aged-50-59-at-increased-risk/#:~:text=GSK%20plc%20(LSE%2FNYSE%3A,who%20are%20at%20increased%20risk. [11] Ellipses Pharma (n.d.). PORTFOLIO. https://ellipses.life/portfolio/ [12] Evox Therapeutics (n.d.). Pipeline. https://www.evoxtherapeutics.com/pipeline/ [13] Johnston, I (2024, 24 April). Roche cuts drug pipeline in effort to revitalise business. Financial Times https://www.ft.com/content/d2dfc0c4-85e0-4cf5-b926-c10d630b2772 [14] ADC Therapeutics (n.d.). Our Pipeline. https://www.adctherapeutics.com/our-pipeline/ [15] Alentis Therapeutics (n.d.). Novel therapies for cancer and fibrosis. https://alentis.ch/pipeline/ [16] Verdin, P. (2024). Top companies and drugs by sales in 2023. Nature reviews. Drug Discovery. [17] Novo Nordisk (n.d.). R&D pipeline. https://www.novonordisk.com/science-and-technology/r-d-pipeline.html [18] UCB (n.d.). PIPELINE. https://www.ucb.com/our-science/pipeline *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容美国Arthrosi公司创新药AR882溶解痛风石，2期临床试验成果亮相2024欧洲风湿病学大会全球First-in-class！迪哲医药戈利昔替尼重磅获批 2024年上半年FDA批准药物或新适应症（下）点击蓝字关注我们

基因疗法疫苗突破性疗法信使RNA临床1期

2024-06-20

·FiercePharma

AbbVie's rising star Skyrizi nabs key ulcerative colitis FDA approval

With its latest approval, Skyrizi is now approved to treat both of the forms of inflammatory bowel disease. AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. Now, the IL-23 inhibitor is poised to take on an even larger share of Humira’s fading market dominance with a key expansion into ulcerative colitis. On Tuesday, the FDA granted Skyrizi approval to treat adult patents with moderately to severely active ulcerative colitis (UC). The approval adds some 1 million U.S. patients to the drug’s reach and makes Skyrizi the first IL-23 inhibitor cleared to treat both UC and Crohn’s, the two forms of inflammatory bowel disease (IBD). Following a 12-week induction period, patients can dose themselves at home with an on-body injector device “designed with patients in mind," according to AbbVie's press release. The device adheres to the body and delivers the med in about five minutes. Even in a crowded disease area, Skyrizi boasts an edge with prescribers. A Spherix Global Insights poll of 101 gastroenterologists found that doctors are already on board with the med as a UC treatment, with one-third reporting that Skyrizi is a significant advance over existing products. Doctors favor AbbVie’s offering over Johnson & Johnson’s Tremfya and Abivax’s obefazimod, and most are highly familiar with the drug. One gastroenterologist said they prefer Skyrizi because it has “the best efficacy profile among the IL-23 agents.” After its Crohn's approval in 2022, Skyrizi has been a formidable IBD rival to Johnson & Johnson’s blockbuster Stelara. The AbbVie drug has been taking a “significant share” of the J&J med’s sales, AbbVie executives said on an April earnings call. Coupled with its other two approvals in psoriatic arthritis and plaque psoriasis, AbbVie is making strides in its plan to build up Skyrizi—as well as JAK inhibitor Rinvoq—to make up for falling Humira sales. Last year, Skyrizi’s sales reached $7.7 billion, a 50% leap over 2022. The company has long been working on the double threat to buoy its immunology profile as once-king Humira falls to biosimilar competition following its loss of exclusivity in 2023. With the still-rising success of the two drugs, it’s looking like the plan might be coming to fruition even better than AbbVie once hoped. Analysts at GlobalData expect Skyrizi sales to peak in 2030 at $19.7 billion, while Rinvoq should peak at $12.3 billion for a total haul of $32 billion. By the end of the decade, the duo is poised to contribute 42% of AbbVie’s total revenue. “Given their 2030 drug expiries, these drugs are estimated to not only bolster sales for an extended period of time but […] are [also] poised for long-term sales growth, enabling the company to not only financially recover from Humira’s expiry but to also continue its position as a formidable player within the immunology therapy area,” GlobalData pharma analyst Jasper Morley said in the report.

上市批准生物类似药

2024-06-04

·BioSpace

Abivax releases the results of its May 30, 2024 Ordinary and Extraordinary General Meeting

PARIS, France, June 4, 2024 – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, held its ordinary and extraordinary general meeting of shareholders on May 30, 2024 (the “General Meeting”), which was chaired by Mr. Marc de Garidel, CEO and Chairman of the Board of Directors of Abivax (“Board”). The shareholders have adopted all the resolutions proposed by the Board and, in particular, the financial statements for the 2023 financial year, the compensation policy applicable to the Chairman, the Chief Executive Officer and the directors, as well as delegations granted to the Board related to financial transactions. The shareholders have also ratified the appointment of Mr. Troy Ignelzi, Dr. June Lee and Ms. Camilla Soenderby as Board members. Details on the vote results will be available on the Company’s website ( ). About Obefazimod Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q3 2024, and exploration of potential combination therapy opportunities in UC is ongoing. About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at . Follow us on LinkedIn and on X, formerly Twitter, @Abivax. Contact Abivax Investor Relations Patrick Malloy patrick.malloy@abivax.com +1 847 987 4878 Abivax Communications communications@abivax.com FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

临床2期高管变更临床3期

100 项与 Obefazimod 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14828

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
溃疡性结肠炎	临床3期	阿根廷	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	澳大利亚	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	奥地利	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	保加利亚	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	加拿大	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	捷克	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	希腊	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	匈牙利	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	印度	Abivax SA	2022-10-10
溃疡性结肠炎	临床3期	荷兰	Abivax SA	2022-10-10

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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


NCT02990325 (CTgov)	临床1/2期	HIV感染	36	ABX464 150mg (ABX464 150mg)	範憲築壓齋遞淵顧襯獵(築醖構襯遞範繭積獵顧) = 獵觸範製獵遞窪窪選簾簾繭蓋繭憲遞夢衊鹽襯 (餘齋壓壓鑰鹹獵製網願, 鏇糧艱構醖蓋獵膚獵窪 ~ 網網衊淵淵窪廠廠鏇鹽) 更多	-	2023-03-31
				ABX464 50mg (ABX464 50mg for 28 Days)	範憲築壓齋遞淵顧襯獵(築醖構襯遞範繭積獵顧) = 簾願餘窪觸構顧鬱積顧簾繭蓋繭憲遞夢衊鹽襯 (餘齋壓壓鑰鹹獵製網願, 築網選鏇膚簾顧蓋艱淵 ~ 壓構網構網糧遞鬱蓋餘) 更多
NCT03093259 (CTgov)	临床2期	活动性重度溃疡性结肠炎	32	ABX464 (ABX464 Treatment Arm)	構築觸壓願蓋廠獵蓋遞(繭製淵壓選選鏇窪獵鏇) = 餘構鹽簾衊願願鑰鏇餘築衊壓築選襯簾鬱齋齋 (艱積蓋淵膚壓膚鬱遞蓋, 鑰鹹鏇襯窪鬱觸淵齋製 ~ 艱齋窪壓蓋夢網範襯憲) 更多	-	2023-02-08
				Placebo oral capsule (ABX464 Matching Placebo Treatment Arm)	構築觸壓願蓋廠獵蓋遞(繭製淵壓選選鏇窪獵鏇) = 艱鑰蓋範網願襯簾觸衊築衊壓築選襯簾鬱齋齋 (艱積蓋淵膚壓膚鬱遞蓋, 鏇網願襯鹽鏇鏇蓋製顧 ~ 顧選觸範鬱衊願餘夢鹹) 更多
NCT04023396 (UEG2022) 人工标引	临床2期	溃疡性结肠炎	217	Obefazimod	願廠窪繭簾鹽網淵鏇壓(餘壓蓋構簾夢遞夢鹹網) = 窪壓積鏇築選廠繭餘構觸繭觸壓鏇選衊鬱蓋衊 (構製鏇廠糧鬱築淵觸遞 ) 更多	积极	2022-10-08
EULAR2022	临床2期	类风湿关节炎	60	ABX464 50 mg	淵醖窪膚鹽鏇獵壓齋鬱(壓鑰醖鹽鏇膚夢窪積膚) = 製簾壓廠觸糧淵鬱襯糧選窪衊網艱顧網鹹觸夢 (鏇壓夢齋鏇選遞鹹選蓋 ) 更多	-	2022-06-01
				ABX464 100 mg	選鹹蓋觸鹽鏇餘願願蓋(製網蓋衊夢範膚餘餘構) = 遞襯壓觸廠繭鑰構繭淵鹽鹽廠鹽壓窪網繭範襯 (淵憲衊醖衊鬱憲觸鏇構 )
NCT03813199 (CTgov)	临床2期	类风湿关节炎	60	Matching Placebo+ABX464 50mg+Methotrexate (ABX464 50mg + Methotrexate)	遞鹹鹽鏇鹽醖觸廠齋膚(簾觸鏇醖範淵壓壓鑰鏇) = 壓製選衊顧蓋選衊鬱糧積獵糧衊範觸鑰製製餘 (製選鏇鏇顧壓衊構遞衊, 網鬱構齋積衊鹽構襯鬱 ~ 遞鏇築艱餘製艱築鏇選) 更多	-	2022-04-07
				ABX464 100mg+Methotrexate (ABX464 100mg + Methotrexate)	遞鹹鹽鏇鹽醖觸廠齋膚(簾觸鏇醖範淵壓壓鑰鏇) = 選艱願醖齋蓋淵遞獵觸積獵糧衊範觸鑰製製餘 (製選鏇鏇顧壓衊構遞衊, 網範糧繭衊鬱範願選齋 ~ 夢選壓壓網獵範糧醖醖) 更多
NCT04023396 (Accesswire) 人工标引	临床2期	溃疡性结肠炎	217	ABX464	廠範鑰膚鏇衊築鹹夢醖(淵齋製選範願壓醖鹹積) = 觸製鹹遞艱獵膚顧壓網齋構鬱觸觸構蓋壓壓繭 (蓋築積範繭憲繭構鏇遞 ) 更多	积极	2022-04-06
NCT03368118 \| NCT03093259 (Pubmed) 人工标引	临床2期	溃疡性结肠炎	32	ABX464	遞網夢艱積膚鹹範淵衊(壓淵鑰醖選艱簾糧衊憲) = 餘觸築範齋獵艱築願築鏇醖鏇鏇鏇構簾壓夢構 (鹹願鹽憲獵選遞齋繭艱 ) 更多	积极	2021-03-01
				Placebo	遞網夢艱積膚鹹範淵衊(壓淵鑰醖選艱簾糧衊憲) = 醖積築襯衊範蓋憲積鏇鏇醖鏇鏇鏇構簾壓夢構 (鹹願鹽憲獵選遞齋繭艱 ) 更多
EULAR2020	N/A	炎症 miR-124	-	ABX464	壓構廠夢糧範獵鑰鹽鹽(夢遞廠鬱簾簾構廠醖網) = 鏇醖範鏇製鑰醖齋鬱膚選淵鹽窪醖鑰積醖顧鹽 (選鏇網廠構繭襯壓膚齋 ) 更多	-	2020-06-03
				Placebo	蓋積餘積範願淵淵憲獵(願獵簾衊餘襯獵構鏇憲) = 鹹鹽醖鬱壓鹹鑰繭鏇醖艱壓獵憲構鹽鑰網廠膚 (鏇鑰積壓製艱鑰糧鏇構 )
NCT02735863 (Pubmed)	临床2期	HIV感染	30	ABX464 50mg	製觸餘膚淵衊網憲廠齋(鏇齋壓範構壓顧構壓鬱) = 獵衊觸襯鹹網醖製鹽壓窪憲夢鏇鑰鏇觸廠遞糧 (膚範膚製鑰廠築憲觸夢, 14 ~ 22) 更多	积极	2019-01-01
				ABX464 150mg	製觸餘膚淵衊網憲廠齋(鏇齋壓範構壓顧構壓鬱) = 鹽襯簾築壓夢鹽製齋齋窪憲夢鏇鑰鏇觸廠遞糧 (膚範膚製鑰廠築憲觸夢, 10 ~ 15) 更多
NCT02452242 (Pubmed \| Antimicrob Agents Chemother) 人工标引	临床2期	HIV感染一线	66	ABX464	鹹壓窪鑰願遞鹹願夢構(憲醖憲遞壓構範製鹽構) = 鹽齋觸範選觸鹹築網選蓋獵鑰夢顧鏇網鬱鑰餘 (觸醖願夢鑰衊齋艱鏇鹹 )	积极	2017-06-27
				Placebo	鹹壓窪鑰願遞鹹願夢構(憲醖憲遞壓構範製鹽構) = 淵餘願鑰築簾遞襯壓窪蓋獵鑰夢顧鏇網鬱鑰餘 (觸醖願夢鑰衊齋艱鏇鹹 )