A Double-blind, Radomized, Placebo-Controlled, Phase 1 Study, to Evaluate the Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Japanese Nonalcoholic Fatty Liver Disease (NAFLD) patients.

开始日期2021-06-12

申办/合作机构-

NCT04171765

/ Terminated临床2期

A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

开始日期2020-09-30

申办/合作机构

Genentech, Inc.

NCT03060538

/ Completed临床1期

A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous BFKB8488A in Patients With Type 2 Diabetes Mellitus and Patients With Non-Alcoholic Fatty Liver Disease

This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.

开始日期2017-03-05

申办/合作机构

Genentech, Inc.

100 项与 Fazpilodemab 相关的临床结果

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100 项与 Fazpilodemab 相关的转化医学

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100 项与 Fazpilodemab 相关的专利（医药）

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项与 Fazpilodemab 相关的文献（医药）

2024-04-01·CPT-Pharmacometrics & Systems Pharmacology

Simulation‐based evaluation of personalized dosing approaches for anti‐FGFR/KLB bispecific antibody fazpilodemab

Article

作者: Yoshida, Kenta ; Kunder, Rebecca ; Kågedal, Matts ; Chinn, Leslie ; Dash, Ajit ; Poon, Victor

Abstract:

Personalized dosing approaches play important roles in clinical practices to improve benefit: risk profiles. Whereas this is also important for drug development, especially in the context of drugs with narrow therapeutic windows, such approaches have not been fully evaluated during clinical development. Fazpilodemab (BFKB8488A) is an agonistic bispecific antibody which was being developed for the treatment of nonalcoholic steatohepatitis. The objective of this study was to characterize the exposure‐response relationships of fazpilodemab with the purpose of guiding dose selection for a phase II study, as well as to evaluate various personalized dosing strategies to optimize the treatment benefit. Fazpilodemab exhibited clear exposure‐response relationships for a pharmacodynamic (PD) biomarker and gastrointestinal adverse events (GIAEs), such as nausea and vomiting. Static exposure‐response analysis, as well as longitudinal adverse event (AE) analysis using discrete‐time Markov model, were performed to characterize the observations. Clinical trial simulations were performed based on the developed exposure‐response models to evaluate probability of achieving target PD response and the frequency of GIAEs to inform phase II dose selection. Dynamic simulation of personalized dosing strategies demonstrated that the AE‐based personalized dosing is the most effective approach for optimizing the benefit–risk profiles. The approach presented here can be a useful framework for quantifying the benefit of personalized dosing for drugs with narrow therapeutic windows.

2020-11-17·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

Antibody-mediated activation of the FGFR1/Klothoβ complex corrects metabolic dysfunction and alters food preference in obese humans

1区 · 综合性期刊

Article

作者: Baruch, Amos ; Vaze, Anjali ; Gelzleichter, Thomas ; Lewin-Koh, Nicholas ; Chinn, Leslie W. ; Arora, Puneet S. ; Gutierrez, Johnny ; Morrow, Linda ; Wilson, Maria E. ; Boismenu, Richard ; Chen, Shan ; Dheerendra, Suresh ; Wong, Chin ; Wakshull, Eric ; Sonoda, Junichiro

Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ (FGFR1/KLB) complexes expressed in adipocytes, pancreatic acinar cells, and the nervous system in mice. Chronic administration of recombinant FGF21 or engineered variants improves metabolic health in rodents, nonhuman primates, and humans; however, the rapid turnover of these molecules limits therapeutic utility. Here we show that the bispecific anti-FGFR1/KLB agonist antibody BFKB8488A induced marked weight loss in obese cynomolgus monkeys while elevating serum adiponectin and the adipose expression of FGFR1 target genes, demonstrating its action as an FGF21 mimetic. In a randomized, placebo-controlled, single ascending-dose study in overweight/obese human participants, subcutaneous BFKB8488A injection caused transient body weight reduction, sustained improvement in cardiometabolic parameters, and a trend toward reduction in preference for sweet taste and carbohydrate intake. These data suggest that specific activation of the FGFR1/KLB complex in humans can be used as therapy for obesity-related metabolic defects.

Hepatology (Baltimore, Md.)

Fibroblast growth factor receptor 1/Klothoβ agonist BFKB8488A improves lipids and liver health markers in patients with diabetes or NAFLD: A phase 1b randomized trial

Article

作者: Chen, Shan ; Liu, Yanqiu ; Dash, Ajit ; Kunder, Rebecca ; Lewin‐Koh, Nicholas ; Fredrickson, Jill ; Yoshida, Kenta ; Gutierrez, Johnny ; Wong, Chin

Abstract:

Background and Aims:

BFKB8488A is a bispecific antibody targeting fibroblast growth factor receptor 1c and Klothoβ. This phase 1b study assessed safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of BFKB8488A in patients with type 2 diabetes mellitus (T2DM) or NAFLD.

Approach and Results:

Patients were randomized to receive multiple doses of BFKB8488A at various dose levels and dosing intervals (weekly, every 2 weeks, or every 4 weeks) or placebo for 12 weeks. The primary outcome was the safety of BFKB8488A. Overall, 153 patients (T2DM: 91; NAFLD: 62) were enrolled and received at least one dose of treatment. Of these, 102 patients (62.7%) reported at least one adverse event (BFKB8488A: 83 [68.6%]; placebo: 19 [59.4%]). BFKB8488A exhibited nonlinear pharmacokinetics, with greater than dose‐proportional increases in exposure. The treatment‐emergent antidrug antibody incidence was 22.7%. Overall, trends in exposure‐dependent increases in high‐density lipoprotein (HDL) and decreases in triglyceride levels were observed. Decreases in alanine aminotransferase and aspartate aminotransferase were 0.7% and 9.2% for medium exposure and 7.3% and 11.2% for high‐exposure tertiles, compared with increases of 7.5% and 17% in the placebo group, respectively, at Day 85. In patients with NAFLD, the mean decrease from baseline liver fat was 13.0%, 34.5%, and 49.0% in the low‐, medium‐, and high‐exposure tertiles, respectively, compared with 0.1% with placebo at Day 85.

Conclusions:

BFKB8488A was adequately tolerated in patients with T2DM or NAFLD, leading to triglyceride reduction, HDL improvements, and trends in improvement in markers of liver health for both populations and marked liver fat reduction in patients with NAFLD. (ClinicalTrials.gov: NCT03060538).

项与 Fazpilodemab 相关的新闻（医药）

2025-03-13

·智药邦

Drug Discov Today｜罗氏：用虚拟患者拥抱医学的未来

2025年2月26日，来自罗氏的研究人员在Drug Discovery Today上发表文章Embracing the future of medicine with virtual patients，阐述了虚拟患者技术如何变革医疗研发，并通过研发价值链中的实际案例展示其整合应用的变革潜力。虚拟患者技术正通过整合多维度数据与AI建模，重构医疗健康生态。该技术通过采集患者个体生理参数、基因特征及生活方式数据，构建动态数字孪生体，实现个性化治疗方案的精准模拟。在患者层面，虚拟患者可预测药物疗效与副作用，支持以患者为中心的精准用药策略，提升治疗有效性与安全性。社会层面，虚拟患者通过构建多样化群体仿真模型，推动包容性临床试验，减少对动物实验的依赖，同时提升药物可及性，助力健康公平。其应用可降低药物研发成本，缩短周期，通过预测模型优化剂量方案，减少药物相关死亡率。制药领域，虚拟患者整合器官芯片、类器官技术及真实世界数据，革新研发流程。结合AI算法与电子健康记录，实现药物靶点验证、临床试验设计及疗效预测的智能化，加速候选药物筛选与审批进程。监管机构正积极制定政策框架，美国FDA与欧盟EMA已启动虚拟患者在药物开发中的合规性探索，标志着技术转化的关键突破。随着技术迭代，虚拟患者将深度融入临床决策支持系统，推动精准医学发展，优化资源配置，最终实现从经验医疗向数据驱动医疗的范式转变。理解数字孪生与虚拟患者的区别 “虚拟患者”与“数字孪生”常被混用，但二者范围不同。虚拟患者是基于群体数据参数分布构建的仿真模型，代表具有生物学合理特征的假设患者，用于药物开发和监管决策中模拟不同患者对治疗的反应。这些仿真通过优化药物剂量、疗效与安全性，帮助研究者探索多种场景而无需大量真实试验。数字孪生则是基于个体患者详细数据生成的个性化模型，通过持续更新数据提供精准治疗策略。本文主要讨论广义的虚拟患者，但具体案例中会提及数字孪生。虚拟患者推动制药研发的演进虚拟患者越来越多地用于药物发现与开发，以模拟药物行为、预测疗效并加速进程。通过生成式AI、机制模型和先进体外系统，虚拟患者可建模从细胞到全身的系统，助力疾病理解、生物标志物发现及药物开发。其应用包括加速药物开发、预测患者反应及支持个性化医疗。通过在虚拟空间中测试多种可能性，虚拟患者允许更多实验以虚拟方式完成，随后在实际研发中验证结果并反馈迭代。这一过程提高了选择正确分子、优化临床试验患者筛选及减少传统试错法的概率。图1 通过虚拟患者与数字孪生加强药物发现与开发在加速研发的背景下，数字孪生通过提供个体患者实时响应的高精度模拟补充虚拟患者。虚拟患者基于群体数据模拟广泛反应，而数字孪生通过真实个体数据细化模型，从而提升虚拟临床试验的预测能力。构建有效的数字孪生需长期监测以捕捉疾病进展，利用电子健康记录（EHR）、患者注册库及历史临床试验的真实世界证据（RWE）提供基线数据。虚拟患者通过详细模拟优化临床试验招募的定位与分层，数字孪生则通过实时健康数据维护个体化档案，将患者匹配至相关试验。数字孪生在个性化医疗中通过持续监测患者反应并实时调整治疗方案展现显著优势，其动态模型能反映当前健康状态，从而提升疗效并减少不良反应。对研发效率的潜在影响虚拟患者技术可通过提升技术成功概率（PTS）、降低成本并缩短周期，彻底改变药物开发流程。表1 虚拟患者技术对技术成功概率（PTS）、成本及研发周期时间的潜在影响示例值得注意的是，AI发现的药物在I期试验中成功率显著高于传统方法。近期分析显示，AI药物的I期成功率达80–90%，远高于行业历史平均值（40–65%）。若后期试验保持此趋势，制药行业的开发能力可能翻倍。安全性是关键，但AI药物的I期成功也归因于优化的ADME（吸收、分布、代谢、排泄）特性及初步疗效。尽管虚拟患者潜力巨大且已有成功案例，其系统化应用尚未普及。本文通过现有案例探讨其如何改变药物开发流程。虚拟患者技术的应用案例虚拟患者技术显著提升药物研发价值链的多个环节，包括靶点识别、患者特异性治疗计划、药物相互作用（DDI）模拟、患者反应预测及临床结果预测，从而优化决策与开发流程。图2 展示虚拟患者技术优势的应用案例当前在药物发现中的应用虚拟患者技术通过整合人工智能与多组学数据，在药物研发早期阶段展现出显著优势。在靶点发现环节，其基于患者特征的预测模型可加速阿尔茨海默病等复杂疾病的靶点验证，通过个体层面的基因 / 蛋白敲除模拟，已成功识别疾病驱动基因并优化药物作用通路，显著降低 II 期临床试验失败率（传统研发痛点）。基于生理药代动力学（PBPK）模型的虚拟评估系统，可快速预测药物体内行为，将候选药物筛选效率提升40%以上，同时减少60%的动物实验需求。在转化医学领域，芯片肺等体外系统结合虚拟患者建模，实现了呼吸系统疾病的机制研究突破；患者源性微型结肠模型则为结直肠癌微环境的长期动态解析提供了高分辨率平台。最新研究表明，机制模型与虚拟患者的协同应用可优化实验设计参数，使药代动力学（PK）和药物相互作用（DDI）预测精度提升35%，为创新疗法的临床转化奠定关键基础。这些技术的整合应用正推动药物研发向精准化、高效化方向加速演进。当前在临床试验中的应用实现精准剂量与疗程优化：在II/III期研究中优化药物剂量和疗程是开发关键。虚拟患者通过整合临床前数据、生物标志物及早期临床数据，可预测药物安全性、有效性及药代动力学（PK），助力制定更可靠的给药策略。例如在fazpilodemab治疗系统性红斑狼疮的研究中，通过动态模拟和马尔可夫模型整合群体PK与不良事件数据，使剂量选择精度提升40%，显著减少试错成本。个体化给药方案：1）液体活检整合：Rostami-Hodjegan团队通过25例肾功能差异患者的血浆外泌体检测，结合PBPK模型建立虚拟孪生，使个体化给药的暴露变异性降低64%（五倍对比十四倍）。2）肝硬化患者剂量调整：基于PBPK的虚拟患者模型在6种药物评估中，对肝硬化患者的PK预测精度达92%，为脆弱人群用药安全提供新范式。个性化安全评估：1）心脏毒性预测：西酞普兰（citalopram）的定量系统毒理学模型通过整合hERG通道抑制数据，使心脏毒性预测准确率提升35%。2）细胞因子释放综合征预警：glofitamab治疗DLBCL的预测模型以94%真阳性率识别高危患者，结合PBPK模型实现CRS相关DDI风险量化。特殊人群模拟创新：1）儿童用药开发：奥司他韦婴儿适应症获批中，PBPK模型替代幼年狨猴重复给药毒性试验，节省12个月研发时间；2）罕见病外推：entrectinib儿科模型成功预测CYP3A4抑制剂联用暴露变化，支持无需额外临床试验的监管批肿瘤试验效率革命：在mosunetuzumab I期试验中，基于QSP的数字孪生技术揭示药物暴露与肿瘤缓解率的剂量-效应关系；发现肿瘤大小、增殖率及T细胞浸润等应答生物标志物；使剂量优化决策效率提升50%。临床决策支持系统：1）kML模型：结合治疗中血液标志物动态与机器学习，使晚期NSCLC患者生存预测精度提升28%。2）ROPRO评分：整合27个变量的多因素预后模型，使临床试验患者筛选效率提高40%，样本量需求减少30%。减少对照组规模：Unlearn AI与强生合作显示，数字孪生可将阿尔茨海默病III期试验对照组规模减少33%。超越药物的解决方案以连续血糖监测（CGM）为例，数字孪生整合患者血糖、胰岛素剂量与饮食数据，可提前预测高/低血糖事件并发出预警。在COVID-19期间，基于智能手机的远程精准剂量系统（如PERSONAL-CovidBP试验）实现了高血压患者的个性化用药，减少了线下就诊需求。实施虚拟患者的推动因素及挑战虚拟患者技术在医疗领域的应用前景广阔，但仍面临多重技术与实施挑战。患者异质性建模药物反应因个体生理差异而异，模型需精准捕捉生物过程复杂性及药效/安全/药代动力学的动态变化。结合体外模型与液体活检等技术，可量化患者异质性，提升预测精度。模型验证体系通过回顾性分析验证模型预测能力是临床转化的核心。对比历史数据（如DDI预测）可优化模型参数，建立与监管机构的信任基础，加速审批流程。数据治理困境高质量多源数据（EHR、可穿戴设备等）是建模基础，但数据孤岛、隐私保护及标准化缺失制约发展。需构建跨机构协作机制，采用联邦学习、区块链等技术保障数据安全共享。监管与伦理挑战需通过真实世界证据（RWE）证明临床价值，同时符合GDPR等法规要求。伦理层面需关注算法偏见（如特殊人群代表性不足），建立动态伦理审查框架。技术生态构建跨学科协作（生物学家+工程师+临床医生）与数据互操作性是关键。开发标准化接口与开源工具包，降低技术应用门槛，推动从研发到临床的全链条渗透。未来发展方向随着AI与数字孪生技术的融合，虚拟患者将向实时动态预测演进。通过整合多组学数据与强化学习，其在个体化治疗、罕见病研究及公共卫生决策中的价值将持续释放。结论虚拟患者技术通过模拟患者特异性场景，正在革新医疗保健与制药研发。其优势包括提升个性化治疗、优化临床试验、减少动物实验及促进包容性研究。尽管面临数据、隐私与法规挑战，跨学科协作与技术创新将推动其迈向更高效、以患者为中心的未来。参考资料： https://doi.org/10.1016/j.drudis.2025.104322 --------- End --------- 感兴趣的读者，可以添加小邦微信加入读者实名讨论微信群。添加时请主动注明姓名-企业-职位/岗位或姓名-学校-职务/研究方向。

2022-12-12

·PRNewswire

Propulsion of Nonalcoholic Steatohepatitis Pipeline as Novel and Extensive 150+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of nonalcoholic steatohepatitis has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Nonalcoholic Steatohepatitis and the growing research and development activities drive the market. The Companies developing the potential therapies in the last stage of development include Madrigal Pharmaceuticals, Inventiva, Boehringer Ingelheim, and several others. LAS VEGAS, Dec. 12, 2022 /PRNewswire/ -- DelveInsight's ' Nonalcoholic Steatohepatitis Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline nonalcoholic steatohepatitis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the nonalcoholic steatohepatitis pipeline domain. Key Takeaways from the Nonalcoholic Steatohepatitis Pipeline Report DelveInsight's nonalcoholic steatohepatitis pipeline report depicts a robust space with 130+ active players working to develop 150+ pipeline therapies for nonalcoholic steatohepatitis treatment. Key nonalcoholic steatohepatitis companies such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others are evaluating nonalcoholic steatohepatitis drugs to improve the treatment landscape. Promising nonalcoholic steatohepatitis pipeline therapies in various stages of development include TERN-101, SNP-610, LJN452 (tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. In November 2022, Sagimet Biosciences announced positive interim data from its Phase IIb clinical trial (FASCINATE-2) with denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis patients. Data showed statistically significant improvements across key markers of NASH, reinforcing results observed in earlier studies, including statistically significant reductions in markers of liver fat, inflammation, and fibrosis. There were no treatment-related serious adverse events, with the majority of adverse events mild to moderate in nature (Grade 1 and 2). Additional interim data are expected in early 2023. In November 2022, Inventiva announced that the United States Patent and Trademark Office granted a patent (U.S. Patent No. 11,504,380) that protects the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage. This patent will expire on November 8, 2039. This patent further expands the intellectual property protection of lanifibranor in the United States for use in patients with cirrhotic NASH. In October 2022, Galectin Therapeutics, Inc. reported the positive outcome of its second data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase IIb/III study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The objective of this second independent DSMB was further to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE could continue as designed, without modifications. In September 2022, Inventiva and Chia Tai-Tianqing Pharmaceutical Group entered into a licensing and collaboration agreement to develop and commercialize lanifibranor, if approved, for the treatment of nonalcoholic steatohepatitis and potentially other metabolic diseases in mainland China, Hong Kong, Macau, and Taiwan. In June 2022, Poxel SA announced that the U.S. Patent and Trademark Office (PTO) has issued to Poxel US Patent No. 11319313, which represents a new patent for PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which is being investigated in Phase II stage of clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis (NASH). In May 2022, Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). In May 2022, Hepion Pharmaceuticals, Inc. announced that it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for evaluating liver function and health in patients with chronic liver diseases. Hepion will incorporate the HepQuant 'SHUNT' test into a dedicated Phase IIb clinical trial in presumed NASH F3 subjects. In February 2022, the US Food and Drug Administration (FDA) granted a Fast-Track Designation to Axcella Therapeutics' AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. In January 2022, LISCure Biosciences announced that it had executed a research collaboration agreement with Mayo Clinic for new drug development for rare liver diseases. LISCure Biosciences Inc. has executed a research collaboration agreement with US based-Mayo Clinic for new drug development for rare liver diseases. Request a sample and discover the nash drugs in development 2022 @ Nonalcoholic Steatohepatitis Pipeline 2022 Report The nonalcoholic steatohepatitis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage nonalcoholic steatohepatitis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the nonalcoholic steatohepatitis clinical trial landscape. Nonalcoholic Steatohepatitis Overview Nonalcoholic steatohepatitis (NASH) is a type of liver inflammation and damage caused by fat buildup. It is one of several conditions known as nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease is classified into two types: isolated fatty liver, in which only fat accumulates, and nonalcoholic steatohepatitis, in which fat, inflammation, and liver cell damage occur. NASH does not usually cause symptoms. Most people with NASH feel fine and are unaware that they have it. As NASH progresses and liver damage worsens, a patient may experience fatigue, weight loss, general weakness, and acne in the upper right part of the belly. Screening for nonalcoholic fatty liver disease in the general population is not advised. It is usually considered after discovering unexplained liver enzyme levels, or imaging reveals hepatic steatosis. A patient's medical history, a physical exam, and tests for nonalcoholic steatohepatitis are used by doctors. Want to discover how the Nash treatment pipeline will look like? Request for sample @ NASH Drug Pipeline 2022 A snapshot of the Nonalcoholic Steatohepatitis Pipeline Drugs mentioned in the report: Want to know how nash dash the pipeline race is for new agents? Download the sample page @ NASH Clinical Trials Nonalcoholic Steatohepatitis Therapeutics Assessment The nonalcoholic steatohepatitis pipeline report proffers an integral view of nonalcoholic steatohepatitis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Nonalcoholic Steatohepatitis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Parenteral, Oral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Biologic, Cell therapy, Peptide, Protein, Small molecule Therapeutics Assessment By Mechanism of Action: Adiponutrin inhibitor, Diacylglycerol O acyltransferase inhibitor, Adiponutrin modulator, RNA interference, Glucagon like peptide 1 receptor agonist, Ornithine decarboxylase stimulant, Farnesoid X-activated receptor agonist, Thyroid hormone receptor beta agonist, Mitochondrial membrane transport protein modulator, Thyroid hormone receptor beta agonists, Peroxisome proliferator-activated receptor alpha agonist Key Nonalcoholic Steatohepatitis Companies:Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others. Key Nonalcoholic Steatohepatitis Pipeline Therapies: TERN-101, SNP-610, LJN452(tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others. Dive deep into rich insights for nonalcoholic steatohepatitis research; visit @ NASH Treatment Pipeline Table of Contents For further information on the most promising nash drugs, reach out @ NASH Medication Pipeline Related Reports Nonalcoholic Steatohepatitis Epidemiology Nonalcoholic Steatohepatitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted nonalcoholic steatohepatitis epidemiology in the 7MM. Nonalcoholic Steatohepatitis Market Nonalcoholic Steatohepatitis Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key nonalcoholic steatohepatitis companies, including Boehringer Ingelheim, Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, Cirius Therapeutics, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non-alcoholic fatty liver disease companies including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced non-alcoholic fatty liver disease companies, including AstraZeneca, Novartis, Pfizer, Roche, among others. Non-Alcoholic Fatty Liver Disease Epidemiology Non-Alcoholic Fatty Liver Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted non-alcoholic fatty liver disease epidemiology in the 7MM. Other Trending Reports Alcohol Use Disorder Market | Liver Cancer Market | Alcoholic Hepatitis - Market | Acute Liver Failure - Market | Liver Angiosarcoma - Market | Liver Cirrhosis - Market | Chronic Liver Disease - Market | Advanced Liver Cancer - Market | Acute On Chronic Liver Failure (ACLF) Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research LLP

临床2期引进/卖出快速通道

2022-02-03

·BioSpace

Roche Abandons Crohn’s Program Following Mixed Topline Verdict

In Roche’s 2021 annual report, the company detailed that group sales rose 9%, pharmaceutical sales were up 3%, and diagnostics up a whopping 29%. The company noted that it had halted a Phase III development program for etrolizumab for Crohn’s disease, as well as a few others in the middle of all financial news. Roche's big approvals in the fourth quarter included Susvimo and Vabysmo for age-related blindness in the U.S.; in Europe, Gavreto for a specific form of advanced lung cancer, Actemra/RoActemra for severe COVID-19 and Ronapreve for non-hospitalized COVID-19 patients and prophylaxis. In the diagnostics arena, in the fourth quarter, the company noted approvals for its cobas 5800 molecular laboratory system, Avenio Edge sequencing sample preparation system, cobas pulse and cobas infinity edge digital ecosystem for clinical decision support and additional SARS-CoV-2 tests. The company expects sales for 2022 to be stable or to grow in the low-single digits. And in what is a hopeful sign for the world but not necessarily for Roche’s bottom line, the company said it expects sales of COVID-19-related drugs and diagnostics to fall by approximately CHF 2 billion ($2.17 billion) with sales drops for biosimilars of around CHF 2.5 billion ($2.7 billion). Otherwise, group sales are projected to grow in the high-single digit range. “We achieved good results in 2021,” stated Severin Schwan, Roche’s Chief Executive Officer. “The demand for our new medicines and diagnostics remains very high. I am particularly pleased with the progress of our product pipeline across several areas, including oncology, vision loss and neurological diseases. Based on our strong product portfolio in both divisions and the promising product pipeline, we are well-positioned for future growth.” In August 2020, Roche announced mixed topline results for its Phase III program of etrolizumab in patients with moderately to severely active ulcerative colitis, an inflammatory bowel disease similar to Crohn’s disease. The drug hit the primary endpoint of inducing remission compared to placebo in two of three studies, but the drug missed the primary endpoint versus placebo as maintenance therapy in ulcerative colitis. At the time, Dr. Levi Garraway, Roche’s chief medical officer and head of global product development, said, “We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options. We are fully analyzing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial program ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participations.” The studies in Crohn’s disease with and without previous anti-TNF treatment was continuing in the Phase III BERGAMOT trial and open-label extension and safety monitoring study (JUNIPER). Etrolizumab is a dual anti-integrin designed to selectively inhibit alpha4beta7 and alphaEbeta7 to control the trafficking of immune cells into the gut and their inflammatory effects on the lining of the gut. Whatever data on these studies Roche observed, it wasn’t strong enough to throw more time and money at. Roche also announced another Phase III program it was axing, RG6422, an oral COVID-19 antiviral it was developing with Atea Pharmaceuticals. In Phase II, Roche was halting SPK-7001, a choroideremia gene therapy it was developing with Spark Therapeutics, and RG7992 for nonalcoholic steatohepatitis (NASH), and RG7835 for autoimmune disorders.

基因疗法生物类似药

100 项与 Fazpilodemab 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
非酒精性脂肪性肝炎	临床2期	美国	Genentech, Inc.	2020-09-30
非酒精性脂肪性肝炎	临床2期	比利时	Genentech, Inc.	2020-09-30
非酒精性脂肪性肝炎	临床2期	法国	Genentech, Inc.	2020-09-30
非酒精性脂肪性肝炎	临床2期	波多黎各	Genentech, Inc.	2020-09-30
非酒精性脂肪性肝炎	临床2期	西班牙	Genentech, Inc.	2020-09-30
2型糖尿病	临床1期	美国	Genentech, Inc.	2017-03-05
2型糖尿病	临床1期	加拿大	Genentech, Inc.	2017-03-05
代谢功能障碍相关的脂肪肝病	临床1期	加拿大	Genentech, Inc.	2017-03-05
胰岛素抵抗	临床1期	美国	Genentech, Inc.	2015-10-29
肥胖	临床1期	美国	Genentech, Inc.	2015-10-29

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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


NCT04171765 (BANFF, CTgov)	临床2期	非酒精性脂肪性肝炎	46	Placebo	糧襯觸壓鑰積製壓鑰膚 = 鑰願鹹選淵膚範襯願製憲範鬱鏇鹽鹽憲築鑰遞 (夢繭網選獵製衊構範壓, 鑰簾鑰積築醖網鑰積願 ~ 襯願艱餘範淵襯壓簾簾) 更多	-	2024-04-16
NCT03060538 (Pubmed) 人工标引	临床1期	糖尿病 \| 代谢功能障碍相关的脂肪肝病	153	Fazpilodemab	願網積鏇鏇襯鏇遞構製(網蓋醖鹽糧遞築製願艱) = 餘製築鏇顧鏇鏇壓選齋範糧蓋餘衊繭選蓋壓憲 (顧網艱積壓鏇積衊膚淵 ) 更多	积极	2022-08-22
NCT03060538 (Pubmed) 人工标引	临床1期	糖尿病 \| 代谢功能障碍相关的脂肪肝病	153	Placebo	願網積鏇鏇襯鏇遞構製(網蓋醖鹽糧遞築製願艱) = 襯積膚鹹夢蓋觸選鹽選範糧蓋餘衊繭選蓋壓憲 (顧網艱積壓鏇積衊膚淵 ) 更多	积极	2022-08-22