A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study with Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants with Moderate to Severe Ulcerative Colitis - NX-13-201

开始日期2023-10-16

申办/合作机构

Landos Biopharma, Inc.

NCT05785715 / Active, not recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

开始日期2023-04-24

申办/合作机构

Landos Biopharma, Inc.

NCT04862741 / Completed临床1期

A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

开始日期2021-05-05

申办/合作机构

Landos Biopharma, Inc.

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100 项与 Amelenodor 相关的转化医学

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100 项与 Amelenodor 相关的专利（医药）

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项与 Amelenodor 相关的文献（医药）

2024-05-31·Journal of Crohn's and Colitis

The Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study

Article

作者: Cataldi, Fabio ; Dubinsky, Marla ; Schreiber, Stefan ; Verstockt, Bram ; Colombel, Jean-Frederic ; Yarur, Andres ; Peyrin-Biroulet, Laurent ; Vermeire, Severine ; Panaccione, Remo ; Lichtiger, Simon ; Danese, Silvio ; Rieder, Florian ; Siegmund, Britta ; Mosig, Rebecca ; Feagan, Brian G

AbstractBackground and AimsNX-13 activation of NLRX1 reduces intracellular reactive oxygen species and decreases inflammation in animal models of colitis. A phase 1a trial demonstrated a gut-selective pharmacokinetic profile with good tolerability. This phase Ib study aimed to evaluate the safety, tolerability, and pharmacokinetics of NX-13 in patients with active ulcerative colitis [UC].MethodsWe conducted a multicentre, randomized, double-blind, placebo-controlled trial of NX-13 in patients with active UC. Patients with a Mayo Clinic Score of 4–10 were randomly assigned [3:3:3:1 ratio] to three NX-13 oral dose groups (250 mg immediate release [IR], 500 mg IR, or 500 mg delayed release [DR], or placebo) once daily for 4 weeks. Safety and pharmacokinetics were the primary and secondary objectives, respectively.ResultsThirty-eight patients [11 females] were recruited and randomized to placebo [five], NX-13 250 mg IR [11], NX-13 500 mg IR [11], or NX-13 500 mg DR [11] and received at least one dose. There were no serious adverse events or deaths during the trial. One patient [500 mg DR, 1/11] withdrew due to worsening of UC and a second [500 mg IR, 1/11] on the last day of treatment after a panic attack associated with atrial fibrillation. In the efficacy population [36 patients], clinical improvement in rectal bleeding and stool frequency scores relative to placebo were seen as early as week 2 and endoscopic response was seen at week 4.ConclusionsNX-13 was generally safe and well tolerated with early signs of rapid symptom and endoscopic improvement. This novel mechanism of action warrants further investigation. ClinicalTrials.gov: NCT04862741.

2022-01-02·Drug and Chemical Toxicology4区 · 医学

Exploratory studies with NX-13: oral toxicity and pharmacokinetics in rodents of an orally active, gut-restricted first-in-class therapeutic for IBD that targets NLRX1

4区 · 医学

Article

作者: Hontecillas, Raquel ; Chauhan, Jyoti ; Ehrich, Marion ; Bassaganya-Riera, Josep ; Leber, Andrew ; Zoccoli-Rodriguez, Victoria

Nucleotide-binding oligomerization domain, leucine rich repeat containing X1 (NLRX1) is an emerging therapeutic target for a spectrum of human diseases. NX-13 is a small molecule therapeutic designed to target and activate NLRX1 to induce immunometabolic changes resulting in lower inflammation and therapeutic responses in inflammatory bowel disease (IBD). This study investigates the safety of NX-13 in a seven-day, repeat-dose general toxicity study in male and female Sprague Dawley rats at oral doses of 500 and 1000 mg/kg. Weights, clinical signs, functional observational battery, clinical pathology and histopathology were used for evaluation. Daily oral dosing of NX-13 up to 1000 mg/kg did not result in any changes in weight, abnormal clinical signs or behavior. No significant differences were observed between treated and control rats in hematology or blood biochemistry. Histopathological evaluation of 12 tissues demonstrated no differences between controls and treated rats. There were no changes in weights of brain, heart, kidney, liver or spleen. Pharmacokinetic analysis of a single oral dose of NX-13 at 10 mg/kg in Sprague Dawley rats provided a maximum plasma concentration of 57 ng/mL at 0.5 h post-dose. Analysis of colon tissue after oral dosing with 1 and 10 mg/kg indicated high peak concentrations (10 and 100 µg/g, respectively) that scale in a dose-proportional manner. These experiments suggest that NX-13 is safe and well-tolerated in rats given oral doses as high as 1000 mg/kg with a favorable gastrointestinal localized pharmacokinetic profile, confirming NX-13 as a promising therapeutic for Crohn's disease and ulcerative colitis.

2019-12-15·The Journal of Immunology2区 · 医学

Activation of NLRX1 by NX-13 Alleviates Inflammatory Bowel Disease through Immunometabolic Mechanisms in CD4+ T Cells

2区 · 医学

Article

作者: Hontecillas, Raquel ; Chauhan, Jyoti ; Bienert, Catherine ; Bassaganya-Riera, Josep ; Leber, Andrew ; Zoccoli-Rodriguez, Victoria

AbstractInflammatory bowel disease (IBD) is a complex autoimmune disease with dysfunction in pattern-recognition responses, including within the NLR family. Nucleotide-binding oligomerization domain, leucine rich repeat containing X1 (NLRX1) is a unique NLR with regulatory and anti-inflammatory functions resulting in protection from IBD in mouse models. NX-13 is an orally active, gut-restricted novel drug candidate that selectively targets and activates the NLRX1 pathway locally in the gut. In vitro and in vivo efficacy of NLRX1 activation by NX-13 was examined. Oral treatment with NX-13 alleviates disease severity, colonic leukocytic infiltration, and cytokine markers of inflammation in three mouse models of IBD (dextran sulfate sodium, Mdr1a−/−, and CD45RBhi adoptive transfer). Treatment of naive CD4+ T cells with NX-13 in vitro decreases differentiation into Th1 and Th17 subsets with increased oxidative phosphorylation and decreased NF-κB activation and reactive oxygen species. With stimulation by PMA/ionomycin, TNF-α, or H2O2, PBMCs from ulcerative colitis patients treated with NX-13 had decreased NF-κB activity, TNF-α+ and IFN-γ+ CD4+ T cells and overall production of IL-6, MCP1, and IL-8. NX-13 activates NLRX1 to mediate a resistance to both inflammatory signaling and oxidative stress in mouse models and human primary cells from ulcerative colitis patients with effects on NF-κB activity and oxidative phosphorylation. NX-13 is a promising oral, gut-restricted NLRX1 agonist for treating IBD.

项与 Amelenodor 相关的新闻（医药）

2024-09-06

·Pharmaceutical Technology

NImmune and BioTherapeutics partner on precision medicine development

The deal will aid NImmune in the development of both animal and computational models for inflammatory and autoimmune diseases. Credit: sergey kolesnikov/Shutterstock. NImmune Biopharma has entered a research partnership with BioTherapeutics, aimed at propelling the development of new precision medicines in the field of inflammation and immunology. The deal will enhance NImmune’s capabilities in precision immunology by leveraging BioTherapeutics’ extensive preclinical services and regulatory expertise. NImmune will benefit from BioTherapeutics’ animal models, including pig models for inflammatory bowel disease, pharmacokinetics/pharmacodynamics analysis capabilities and specialised regulatory infrastructure for product testing. The deal will also aid in mechanism of action validation studies and the development of both animal and computational models of autoimmune and inflammatory diseases. BioTherapeutics chief scientific officer Dr Raquel Hontecillas stated: “We are excited to collaborate across teams in support of the development of much-needed therapeutics by providing our highly sophisticated computational and preclinical services, including our proprietary efficacy animal models of autoimmune and inflammatory disease. See Also: Investment opportunities in atopic dermatitis may drive innovation EC approves Merck’s Keytruda-Padcev combo for urothelial cancer “The unique drug development ecosystem created here in Blacksburg enables and equips our organisations to develop safer and more effective therapeutics at an increasingly efficient and accelerated pace.” The partnership with BioTherapeutics adds to NImmune’s existing research and development (R&D) collaboration with the NIMML Institute. Together, they will form a scientific innovation ecosystem that enables transdisciplinary teams to collaborate from discovery through various development phases. This ecosystem has already yielded significant clinical and commercial success, as evidenced by the development of NX-13 and its subsequent acquisition by AbbVie . NImmune founder and CEO Dr Josep Bassaganya-Riera stated: “The collaboration with BioTherapeutics is a crucial extension of NImmune’s innovative R&D ecosystem that is enabling our team to create safer and more effective immunoregulatory therapeutics that address the unmet clinical needs of patients with inflammatory and autoimmune diseases. “Through NImmune’s strategic partnerships with both the NIMML Institute and BioTherapeutics, we have created a best-in-class scientific ecosystem capable of accelerating the pipeline — from AI-enabled target discovery and validation using the TITAN-X platform to preclinical animal modelling to clinical testing and ultimately commercialisation.”

并购

2024-09-05

·Business Wire

NImmune Biopharma Announces R&D Collaboration with BioTherapeutics, Inc. to Advance the Next Wave of Inflammation and Immunology Precision Medicines

BLACKSBURG, Va.--( BUSINESS WIRE )-- NImmune Biopharma ("NImmune”), a late-clinical-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics, today announced a research collaboration with BioTherapeutics, Inc. (“BioTherapeutics”), a clinical-stage biotech company that combines advanced computational modeling with translational and clinical experimentation to accelerate the development of novel products. The collaboration strengthens NImmune’s precision immunology capabilities by providing access to BioTherapeutics’ preclinical services and regulatory capabilities for product testing, mechanism of action validation studies, and development of animal and computational models of inflammatory and autoimmune disease. NImmune will also gain access to BioTherapeutics’ proprietary animal models of disease, including its unique pig models of IBD, PK/PD analysis capabilities and expert regulatory infrastructure. Dr. Raquel Hontecillas, BioTherapeutics Chief Scientific Officer, stated, “ We are excited to collaborate across teams in support of the development of much-needed therapeutics by providing our highly sophisticated computational and preclinical services, including our proprietary efficacy animal models of autoimmune and inflammatory disease. The unique drug development ecosystem created here in Blacksburg enables and equips our organizations to develop safer and more effective therapeutics at an increasingly efficient and accelerated pace.” NImmune’s partnership with BioTherapeutics complements an existing R&D partnership with NIMML Institute , creating a unique scientific innovation ecosystem for transdisciplinary teams to collaborate from discovery through various development phases. This ecosystem demonstrated significant clinical and commercial success this year with BioTherapeutics and NIMML Institute having enabled the development of NX-13 and its acquisition by AbbVie, Inc. (NYSE: ABBV). " The collaboration with BioTherapeutics is a crucial extension of NImmune's innovative R&D ecosystem that is enabling our team to create safer and more effective immunoregulatory therapeutics that address the unmet clinical needs of patients with inflammatory and autoimmune diseases,” said Dr. Josep Bassaganya-Riera, Founder & CEO of NImmune. “ Through NImmune’s strategic partnerships with both the NIMML Institute and BioTherapeutics, we have created a best-in-class scientific ecosystem capable of accelerating the pipeline—from A.I.-enabled target discovery and validation using the TITAN-X platform to preclinical animal modeling to clinical testing and ultimately commercialization. The regulatory infrastructure, preclinical resources, and leading proprietary models of disease and pathology developed and honed at BioTherapeutics allow us to focus NImmune’s organizational energy squarely on advancing clinical development of our immunoregulatory therapeutic pipeline." “ We’re proud to enter this strategic partnership, which combines BioTherapeutics’ validated models of inflammatory and autoimmune diseases with our expertise in rapidly translating fundamental scientific discoveries in immunology into safer and more effective medicines for patients with immune-mediated diseases such as ulcerative colitis, Crohn’s disease, psoriasis, rheumatoid arthritis, asthma, and systemic lupus erythematosus,” continued Dr. Bassaganya-Riera. “ We look forward to the ongoing collaboration between BioTherapeutics and NImmune, as well as the NIMML Institute, to significantly accelerate the clinical development of our high-conviction drug candidates.” About NImmune Biopharma NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s discovery platform is omilancor, a wholly-owned Phase 3-ready oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis and Crohn’s disease with registration-directed pivotal clinical trials planned for 2H’23. Phase 2 proof-of-concept data for omilancor show potential best in class efficacy and safety. For more information, please visit www.NIMMUNEBIO.COM or contact media@nimmunebio.com . About BioTherapeutics, Inc. BioTherapeutics, Inc., a clinical-stage biotech company that synergistically combines the power of advanced computational modeling with translational and clinical experimentation to accelerate the development of novel products for precision medicine and health. The company is headquartered in Blacksburg, VA. For more information, please visit www.biotherapeuticsinc.com .

临床2期并购

2024-08-30

·BiG生物创新社

自免新时代，谁领风骚？

作者｜自由译员Isabelle 8月27日，是中国自免新药历史上不寻常的一天。中午，智翔金泰宣布，国家药品监督管理局批准该公司自主研发用于治疗中重度斑块状银屑病适应症的1类新药塞立奇单抗注射液（商品名：金立希®）上市，这是我国首个国产抗IL-17药物。晚间，恒瑞医药披露，子公司苏州盛迪亚生物医药有限公司获得了自主研发的1类新药夫那奇珠单抗注射液的上市批准，该药用于治疗适合接受系统治疗或光疗的中重度斑块状银屑病的成人患者，作用靶点也是IL-17A。曾几何时，艾伯维的修美乐（Humira®）连续11年登顶全球“药王”宝座，一路助推艾伯维。但从2023年开始，随着修美乐跌落专利悬崖，自免领域逐渐从“独乐乐”走向“众乐乐”，“后修美乐”时代，群雄并起。本文将从国际和国内两个维度，梳理“秦失其鹿，天下共逐之”背景下的激烈攻伐。 01 MNC：新王登基，次席胶着从今年前两个季度的销售数据来看，赛诺菲与再生元联合开发的度普利尤单抗 (Dupixent®) 一马当先，以66亿美元的销售额与一众自免竞品拉开差距，新王的王座貌似已坐稳。来源：各药厂一、二季度报半年报 Dupixent®是注射用IL-4Rα拮抗剂，经FDA批准可用于五种疾病：湿疹（特应性皮炎）、哮喘、慢性鼻窦炎伴鼻息肉、嗜酸性食管炎、结节性痒疹。2017年3月首次获得FDA批准。不出意外的话，今年Dupixent®会彻底取代Humira®的王者之位。更让人激动的是，7月，Dupixent®已在欧洲获批用于慢性阻塞性肺病 (COPD)，要知道，十多年了，这是首个治疗COPD的新方法，也为欧盟约22万成年人提供了新选择。在美国、日本、中国的审批也已在进行中，我们不妨期待一下。待批的适应症还有慢性自发性荨麻疹（欧洲）。 Dupixent®在水疱性天疱疹、起因不明的慢性瘙痒、慢性自发性荨麻疹（美国）、嗜酸细胞性胃炎的临床试验也已进行至三期。相比Dupixent®明显领先的优势，次席的情形尚不明朗。目前暂居第二位的是强生的乌司努单抗 (Stelara®)，但是它与Humira®和艾伯维的后浪利生奇珠单抗 (Skyrizi®) 相差不大。Humira®已在走下坡路，预计不会对Stelara®构成威胁，但Skyrizi®还有翻盘的机会。 Stelara®是首款靶向IL-12和IL-23的药物，用于治疗银屑病、银屑病性关节炎、克罗恩病、溃疡性结肠炎。2008年首次于加拿大获批。目前该药还有两种适应症正在审批中，分别是小儿青少年银屑病性关节炎和小儿克罗恩病。值得注意的是，该药目前只有一款管线在研了，是小儿溃疡性结肠炎，进行至三期试验。目前强生的免疫管线中，最多的是古塞奇尤单抗 (TREMFYA®)和丽铂卡利 (nipocalimab)。这或许与Stelara®去年九月在美国的专利开始到期有关，强生早已开始未雨绸缪。这也是或许它会被Skyrizi®后来居上的原因。 TREMFYA®是首个获批的全人双作用单克隆抗体，可与IL-23上的p19亚基结合，亦可与CD64结合，阻断IL-23，CD64是一种受体，位于产生IL-23的细胞上。IL-23是炎症性疾病发病机制的重要驱动因子。目前进行中的试验包括小儿溃疡性结肠炎、小儿青少年银屑病性关节炎、小儿克罗恩病、溃疡性结肠炎皮下诱导、银屑病关节炎结构损伤、小儿银屑病。 Nipocalimab是强生于2020年通过收购Momenta获得的资产，是经过临床验证的、潜在同类最佳的抗新生儿 Fc 受体 (FcRn) 抗体。目前进行中的试验包括胎儿新生儿溶血病、温热自身免疫性溶血性贫血、特发性炎性肌病、干燥症、系统性红斑狼疮、类风湿性关节炎。艾伯维的Skyrizi®同样是IL-23抑制剂，与IL-23的p19亚基结合，阻断IL23。2019年4月首次获得FDA批准，目前可治疗斑块型银屑病、银屑病性关节炎、克罗恩病和溃疡性结肠炎。今年6月，FDA批准Skyrizi®用于中重度溃疡性结肠炎，标志着Skyrizi®成为首个获批既可用于中度至重度溃疡性结肠炎又可用于中度至重度克罗恩病的IL-23特异性抑制剂，彰显了艾伯维在炎症性肠病 (IBD) 领域扩张的雄心。 MNC自免布局的一大特点是不断扩大适应症范围，其中，艾伯维尤其看重IBD。仅今年上半年，艾伯维就已四度出手IBD： 3月20日，艾伯维与Parvus Therapeutics宣布签署全球独家许可合作和选择权协议，结合艾伯维在免疫学上的专业技术和Parvus富有创新性的调节性T细胞 (Treg) 免疫耐受平台技术Navacim™，开发IBD疗法。 3月25日，艾伯维购买了专注于为自免疾病病人开发新颖口服疗法的临床阶段生物制药公司Landos Biopharma, Inc.，获得了NX-13，一种同类首创口服NLRX1激动剂（NOD样受体家族成员之一），具有双向作用机制，可以抗炎，有助于上皮修复。 6月13日，艾伯维与北京明济生物有限公司宣布签署许可协议，共同开发FG-M701，这是治疗IBD的下一代TL1A抗体，目前处于临床前开发阶段，是靶向TL1A的完全人类单克隆抗体，TL1A是经过临床验证的IBD靶点。 6月30日，艾伯维以2.5亿美元的价格收购初创公司Celcius Therapeutics，后者的主导项目是CEL383，这是一种用来阻断TREM1蛋白的抗体。TREM1起加重炎症的作用，在某些免疫细胞上表达，是其他炎症通路的上游，充当炎症放大器。 JAK抑制剂乌帕替尼 (Rinvoq®) 同样来自艾伯维，它可以在细胞内发挥作用，阻断某些被认为会引起炎症的信号，可治疗8种炎症疾病，含类风湿性关节炎、银屑病性关节炎、湿疹。2019年8月首次获得FDA批准，迄今已获得7次FDA批准。7月，艾伯维向FDA提交了用Rinvoq®治疗新适应症成人巨细胞动脉炎 (GCA) 的申请，GCA是一种影响大中型动脉的自免疾病。去年7月，Rinvoq®获得中国国家药品监督管理局 (NMPA）的批准，成为国内首个口服高选择性JAK抑制剂，用于治疗成人中重度活动性克罗恩病。艾伯维对两位后起之秀Skyrizi®和Rinvoq®寄予了厚望，认为它们2025年各自的销售额都可以超过75亿美元。虽然修美乐已让位于Dupixent®，但是不同于艾伯维三驾马车齐头并进，赛诺菲在自免领域只有Dupixent®一个重磅炸弹药物。所以，对比艾伯维与赛诺菲的半年报可以发现，“自免一哥”仍是艾伯维。托珠单抗 (Actemra/RoActemra) 作为罗氏在自免领域的当家花旦，2010年1月首次获得FDA批准。可用于治疗类风湿性关节炎、小儿幼年特发性关节炎、系统性青少年特发性关节炎、巨细胞动脉炎、系统性硬化症相关间质性肺疾病、CAR-T诱导的细胞因子释放综合征，最近一次获批是用于治疗新冠。 Actemra/RoActemra是同类首创人源化IL-6受体抑制单抗。据信，IL-6在激活炎症通路方面发挥重要作用，而炎症通路会引发类风湿关节炎和其他炎症性自免疾病的体征和症状。 02 本土企业：紧追不舍、各展所长随着MNC竞争日趋白热化，国内企业也不可能作壁上观，坐视市场被外人瓜分。毕竟，Dupixent®自从2020年首次进入国家医保，销售额已翻了近10倍。纵观国内各免疫大厂的管线，白介素 (IL) 家族和新一代JAK是最大的热门。投身其中的公司既有老牌药企，亦有小而美的biotech。国内部分免疫管线一览，来源：各公司官网很明显，IL-4Rα是吸引最多火力的靶点，这或许是受到Dupixent®这个爆款大单品的影响。从进展来看，康诺亚的司普奇拜单抗CM310跑得最快。另外，除三生制药以外，每一家都有项目进行到三期，肉眼可见，未来几年，这个赛道将迎来扎堆上市。如何保持差异化、在竞争中脱颖而出，将成为入局者不得不面对的挑战。如果说白介素是生物制剂的代表，那么JAK1就是小分子抑制剂的代表。JAK1是JAK家族四种亚型之一（另外三种分别是JAK2、JAK3、TYK2），是多条信号通路的核心，也是唯一可以与其他三种亚型都形成异二聚体的亚型，因此，它与多种炎症、自免疾病关系密切，也因此，我们看到所有JAK抑制剂的研发都集中在JAK1上。目前，国内属恒瑞医药的进度最为领先。除了这些热门靶点外，还有一些靶点也在探索中，如OX40、TSLP、CD38等。写在最后在国际舞台上，自免是仅次于肿瘤的第二大疾病领域；在中国，MNC起步早，获得了一些先发优势。然人无常态，事无常规，江山代有才人出，各领风骚数百年。Humira®的衰落，是Dupixent®崛起的希望，今日MNC的领先，未尝不是培育他日国产自免创新药物的沃土。百舸争流，谁又能知，苍茫大地，谁主沉浮？参考资料： MedCity News: AbbVie Expands IBD Drug Pipeline Again With $250M Celsius Therapeutics Acquisition PR.com: Parvus Announces Collaboration with AbbVie to Develop IBD Therapies Based on the Parvus Navacim Platform Technology PR Newswire: AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Giant Cell Arteritis 官网：Regeneron、Sanofi、Johnson and Johnson、Abbvie、智翔金泰、恒瑞医药、荃信生物、先声药业、三生制药、康诺亚、康乃德、康方生物、博安生物、百奥泰、君实生物、博锐生物、华博生物凯莱英药闻《刚刚！首个国产抗IL-17药物赛立奇单抗获批上市》东方财富网《恒瑞医药自免疾病领域首个创新药夫那奇珠单抗注射液获批上市》腾讯网“未来智库”《医药行业JAK1抑制剂专题研究：迭代上市，立足自免蓝海市场》共建Biomedical创新生态圈！如何加入BiG会员？ ▼

临床3期上市批准

100 项与 Amelenodor 相关的药物交易

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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2期	美国	AbbVie, Inc.	-
克罗恩病	临床1期	美国	Landos Biopharma, Inc.	2022-01-30

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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


NCT04862741 (Literature) 人工标引	临床1期	溃疡性结肠炎	38	NX-13	(齋淵窪襯糧蓋遞鑰構齋) = none 積顧餘糧獵鑰窪廠淵繭 (糧衊衊範製艱遞壓顧憲 ) 更多	积极	2023-11-11
				Placebo
UEGW2023	N/A	溃疡性结肠炎	-	NX-13 250mg Immediate Release	衊觸蓋繭構襯顧壓窪遞(鹹鹽窪餘遞襯襯觸範艱) = 廠淵齋顧壓壓憲齋艱鏇獵願衊餘鹽選構顧淵網 (衊廠鏇觸繭餘廠憲蓋窪 )	-	2023-10-15
				NX-13 500mg Immediate Release	衊觸蓋繭構襯顧壓窪遞(鹹鹽窪餘遞襯襯觸範艱) = 壓選憲範壓醖膚遞積鬱獵願衊餘鹽選構顧淵網 (衊廠鏇觸繭餘廠憲蓋窪 )
UEGW	N/A	溃疡性结肠炎	-	NX-13 250mg IR	築窪憲願範鑰窪壓窪鹹(蓋繭齋願鹽積廠築構鑰) = 構襯簾餘觸獵遞窪艱蓋積衊選鏇夢遞製鹽鑰廠 (夢糧夢觸積觸醖繭齋窪 ) 更多	-	2023-10-15
				NX-13 500mg IR	築窪憲願範鑰窪壓窪鹹(蓋繭齋願鹽積廠築構鑰) = 觸窪築壓顧鹽遞積獵襯積衊選鏇夢遞製鹽鑰廠 (夢糧夢觸積觸醖繭齋窪 ) 更多
NCT04862741 (Corporate Publications) 人工标引	临床1期	溃疡性结肠炎	38	NX-13	(壓淵積餘艱餘蓋醖齋襯) = no serious adverse events (SAEs) were reported 範齋廠構餘餘願繭遞窪 (鬱廠襯簾糧糧廠憲齋顧 )	积极	2022-08-03
				Placebo
NCT04458805 (PipelineReview) 人工标引	临床1期	炎症性肠病	56	NX-13	(顧鹹鬱醖觸觸範鑰廠餘) = No serious adverse events were reported 淵遞獵衊選淵糧築遞遞 (顧齋膚艱選鑰蓋齋鑰壓 ) 更多	积极	2021-03-04
				Placebo