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/M25-484

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

AbbVie, 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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项与 Amelenodor 相关的文献（医药）

2024-05-31·Journal of Crohn's & 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 ; Danese, Silvio ; Verstockt, Bram ; Schreiber, Stefan ; Siegmund, Britta ; Mosig, Rebecca ; Feagan, Brian G ; Rieder, Florian ; Yarur, Andres ; Colombel, Jean-Frederic ; Vermeire, Severine ; Peyrin-Biroulet, Laurent ; Dubinsky, Marla ; Lichtiger, Simon ; Panaccione, Remo

Abstract:

Background and Aims:

NX-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].

Methods:

We 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.

Results:

Thirty-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.

Conclusions:

NX-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 ; Ehrich, Marion ; Leber, Andrew ; Zoccoli-Rodriguez, Victoria ; Bassaganya-Riera, Josep ; Chauhan, Jyoti

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·Journal of immunology (Baltimore, Md. : 1950)2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 ; Bienert, Catherine ; Leber, Andrew ; Zoccoli-Rodriguez, Victoria ; Bassaganya-Riera, Josep ; Chauhan, Jyoti

Abstract:

Inflammatory 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）

2024-12-15

·药时代

2亿美元现金！艾伯维收购Nimble Therapeutics

好礼相送不停歇！邀您共赏《“飞”凡探索：ASH归来，共话干细胞疗法工艺开发及质量控制 | 大话CGT系列第5期》正文共： 1238字 2图预计阅读时间： 5分钟当地时间2024年12月13日，制药巨头艾伯维公司（AbbVie）宣布将以2亿美元现金收购私人控股公司Nimble Therapeutics。此次收购将使艾伯维获得Nimble的领先资产，包括一种用于治疗银屑病的临床前开发的研究性口服肽IL23R抑制剂，以及其他针对各种自身免疫疾病的新型口服肽产品。 Nimble Therapeutics的专有肽合成平台也将被艾伯维收购，这将有助于艾伯维发现和优化口服肽疗法。Nimble的管线与艾伯维的免疫学专业知识的结合，代表了一个重要的增长机会，有望解决自身免疫性疾病中未被满足的医疗需求。此次交易的完成取决于惯例条件，包括Hart-Scott-Rodino反垄断改进法案规定的等待期。艾伯维近几年频频出手，进行了多笔收购。 2024年收购Aliada Therapeutics：艾伯维以14亿美元收购Aliada Therapeutics，旨在深化其在阿尔茨海默病及神经科学领域的研发布局。Aliada拥有创新的血脑屏障（BBB）穿透技术，这将显著提升艾伯维的研发能力，加速开发针对神经系统疾病的新一代疗法。 2024年收购Celsius Therapeutics：艾伯维以2.5亿美元收购Celsius Therapeutics，获得其TREM1抗体。此次收购旨在推进CEL383的开发，以帮助更多炎症性肠胃炎患者获得缓解。 2024年收购Landos Biopharma：艾伯维以2.12亿美元收购Landos Biopharma，获得其炎症性肠病研发管线NX-13。此次收购的目的是加强艾伯维在炎症性肠病领域的研发能力。 2023年收购Cerevel Therapeutics：艾伯维以87亿美元收购Cerevel Therapeutics，以获得其强大的神经科学管线。此次收购的目的是扩大艾伯维在神经科学领域的影响力。 2023年收购ImmunoGen：艾伯维以101亿美元收购ImmunoGen，获得其“first-in-class”抗体偶联药物（ADC）Elahere。此次收购旨在加速艾伯维在实体肿瘤领域的商业和临床布局。 2020年收购Stemcentrx：艾伯维以58亿美元收购Stemcentrx，获得靶向DLL3的ADC药物Rova-T。此次收购的目的是扩充艾伯维的肿瘤资产，实现产品的多元化。 2019年收购Allergan：艾伯维以630亿美元完成对Allergan的收购，这是艾伯维迄今为止最大的一笔收购。此次收购的目的是为了摆脱对单一品种的过渡依赖，作为一种避险策略。 2015年收购Pharmacyclics：艾伯维以210亿美元收购Pharmacyclics，获得血液瘤重磅新药伊布替尼（Imbruvica）。此次收购的目的是扩充艾伯维的肿瘤管线，增强其在血液瘤领域的竞争力。艾伯维通过这些收购不断扩展其在肿瘤学、神经科学和免疫学等领域的业务版图，巩固其在全球制药行业的领先地位。药时代将继续跟踪报道。欢迎广大朋友们关注！参考资料： AbbVie to Acquire Nimble Therapeutics, Further Strengthening Immunology Pipeline 其它公开资料封面图来源：网络版权声明/免责声明本文为编译文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 2024肝病新药联盟年会圆满落幕！把握时代机遇，攻克肝病顽疾！2024肝病新药联盟年会暨减重新药论坛今日启幕！里程碑！乙肝治愈率首次突破30%大关登上NEJM：侯金林/张文宏等发布siRNA治疗乙肝临床试验结果，大幅提高乙肝表面抗原转阴率点击查看更多精彩！

并购抗体药物偶联物细胞疗法

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.”

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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

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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.	2023-04-24
溃疡性结肠炎	临床2期	比利时	AbbVie, Inc.	2023-04-24
溃疡性结肠炎	临床2期	意大利	AbbVie, Inc.	2023-04-24
溃疡性结肠炎	临床2期	波兰	AbbVie, Inc.	2023-04-24
克罗恩病	临床1期	美国	Landos Biopharma, Inc.	2022-01-30

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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	範淵壓選憲憲廠憲鬱鏇(糧鹹鑰獵齋艱積遞淵襯) = none 範鏇繭顧糧構淵遞鹽餘 (繭膚廠遞夢積簾鹹醖簾 ) 更多	积极	2023-11-11
				Placebo
UEGW2023	N/A	溃疡性结肠炎	-	NX-13 250mg Immediate Release	獵夢鹹鹹淵艱餘衊壓鹽(獵鹹廠壓獵鹹積鏇襯鏇) = 襯衊衊鹽衊鏇顧簾齋網積築顧遞繭壓鹽鑰顧鹽 (願襯壓顧製鑰顧衊糧鹹 )	-	2023-10-15
				NX-13 500mg Immediate Release	獵夢鹹鹹淵艱餘衊壓鹽(獵鹹廠壓獵鹹積鏇襯鏇) = 築繭網襯鏇觸製顧襯遞積築顧遞繭壓鹽鑰顧鹽 (願襯壓顧製鑰顧衊糧鹹 )
UEGW2023	N/A	溃疡性结肠炎	-	NX-13 250mg IR	艱構遞選鬱蓋製選鑰醖(糧憲鹹鏇壓鑰醖廠觸襯) = 簾廠觸網壓簾築製膚壓製願遞顧鑰築願蓋範積 (鬱積憲憲簾顧蓋醖膚鏇 ) 更多	-	2023-10-15
				NX-13 500mg IR	艱構遞選鬱蓋製選鑰醖(糧憲鹹鏇壓鑰醖廠觸襯) = 網窪齋鬱鹽餘製壓廠範製願遞顧鑰築願蓋範積 (鬱積憲憲簾顧蓋醖膚鏇 ) 更多
NCT04862741 (Corporate Publications) 人工标引	临床1期	溃疡性结肠炎	38	NX-13	願築獵範蓋廠窪鬱鑰鏇(淵網淵淵鑰鹽繭簾淵鬱) = no serious adverse events (SAEs) were reported 遞構顧餘鏇齋鏇鏇遞遞 (顧鏇鹽繭艱鹽夢襯鹹夢 )	积极	2022-08-03
				Placebo
NCT04458805 (PipelineReview) 人工标引	临床1期	炎症性肠病	56	NX-13	鹽繭繭顧鑰製鏇餘蓋膚(醖遞齋鹹壓選蓋壓廠淵) = No serious adverse events were reported 鑰膚鹽齋鬱繭衊繭糧壓 (憲糧膚壓遞鏇衊鏇鹽夢 ) 更多	积极	2021-03-04
				Placebo