A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus

This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.

开始日期2023-10-19

申办/合作机构

Carmot Therapeutics, Inc.

NCT05794581 / Recruiting临床1期

A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes

This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.

开始日期2023-03-21

申办/合作机构

Carmot Therapeutics, Inc.

NCT05110846 / Unknown status临床2期

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus

A Study to Assess the effect of CT-868 in hemoglobin A1c (HbA1c) in Overweight and Obese Participants with Type 2 Diabetes Mellitus.

开始日期2022-02-22

申办/合作机构

Carmot Therapeutics, Inc.

100 项与 CT-868 相关的临床结果

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100 项与 CT-868 相关的转化医学

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100 项与 CT-868 相关的专利（医药）

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项与 CT-868 相关的文献（医药）

2024-06-01·Peptides

Immunomodulation and inflammation: Role of GLP-1R and GIPR expressing cells within the gut

Review

作者: Mulvihill, Erin E ; Morrow, Nadya M ; Morissette, Arianne

Glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are peptide hormones produced by enteroendocrine cells in the small intestine. Despite being produced in the gut, the leveraging of their role in potentiating glucose-stimulated insulin secretion, also known as the incretin effect, has distracted from discernment of direct intestinal signaling circuits. Both preclinical and clinical evidence have highlighted a role for the incretins in inflammation. In this review, we highlight the discoveries of GLP-1 receptor (GLP-1R)+ natural (TCRαβ and TCRγδ) and induced (TCRαβ+CD4+ cells and TCRαβ+CD8αβ+) intraepithelial lymphocytes. Both endogenous signaling and pharmacological activation of GLP-1R impact local and systemic inflammation, the gut microbiota, whole-body metabolism, as well as the control of GLP-1 bioavailability. While GIPR signaling has been documented to impact hematopoiesis, the impact of these bone marrow-derived cells in gut immunology is not well understood. We uncover gaps in the literature of the evaluation of the impact of sex in these GLP-1R and GIP receptor (GIPR) signaling circuits and provide speculations of the maintenance roles these hormones play within the gut in the fasting-refeeding cycles. GLP-1R agonists and GLP-1R/GIPR agonists are widely used as treatments for diabetes and weight loss, respectively; however, their impact on gut homeostasis has not been fully explored. Advancing our understanding of the roles of GLP-1R and GIPR signaling within the gut at homeostasis as well as metabolic and inflammatory diseases may provide targets to improve disease management.

2023-08-15·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

Structural analysis of the dual agonism at GLP-1R and GCGR.

1区 · 综合性期刊

Article

作者: Zhao, Fenghui ; Dai, Antao ; Li, Yang ; Ying, Tianlei ; Yang, Dehua ; Wu, Beili ; Chang, Rulue ; Wang, Ming-Wei ; Zhou, Qingtong ; Cong, Zhaotong

Glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), two members of class B1 G protein-coupled receptors, play important roles in glucose homeostasis and energy metabolism. They share a high degree of sequence homology but have different functionalities. Unimolecular dual agonists of both receptors developed recently displayed better clinical efficacies than that of monotherapy. To study the underlying molecular mechanisms, we determined high-resolution cryo-electron microscopy structures of GLP-1R or GCGR in complex with heterotrimeric G_s protein and three GLP-1R/GCGR dual agonists including peptide 15, MEDI0382 (cotadutide) and SAR425899 with variable activating profiles at GLP-1R versus GCGR. Compared with related structures reported previously and supported by our published pharmacological data, key residues responsible for ligand recognition and dual agonism were identified. Analyses of peptide conformational features revealed a difference in side chain orientations within the first three residues, indicating that distinct engagements in the deep binding pocket are required to achieve receptor selectivity. The middle region recognizes extracellular loop 1 (ECL1), ECL2, and the top of transmembrane helix 1 (TM1) resulting in specific conformational changes of both ligand and receptor, especially the dual agonists reshaped ECL1 conformation of GLP-1R relative to that of GCGR, suggesting an important role of ECL1 interaction in executing dual agonism. Structural investigation of lipid modification showed a better interaction between lipid moiety of MEDI0382 and TM1-TM2 cleft, in line with its increased potency at GCGR than SAR425899. Together, the results provide insightful information for the design and development of improved therapeutics targeting these two receptors simultaneously.

2023-03-24·Expert Opinion on Pharmacotherapy

GLP-1/GIP analogs: potential impact in the landscape of obesity pharmacotherapy

Review

作者: Irwin, Nigel ; Lafferty, Ryan A. ; Flatt, Peter R.

INTRODUCTIONObesity is recognized as a major healthcare challenge. Following years of slow progress in discovery of safe, effective therapies for weight management, recent approval of the glucagon-like peptide 1 receptor (GLP-1R) mimetics, liraglutide and semaglutide, for obesity has generated considerable excitement. It is anticipated these agents will pave the way for application of tirzepatide, a highly effective glucose-dependent insulinotropic polypeptide receptor (GIPR), GLP-1R co-agonist, recently approved for management of type 2 diabetes mellitus.AREAS COVEREDFollowing promising weight loss in obese individuals in Phase III clinical trials, liraglutide and semaglutide were approved for weight management without diabetes. Tirzepatide has attained Fast Track designation for obesity management by the US Food and Drug Association. This narrative review summarizes experimental, preclinical, and clinical data for these agents and related GLP-1R/GIPR co-agonists, prioritizing clinical research published within the last 10 years where possible.EXPERT OPINIONGLP-1R mimetics are often discontinued within 24 months meaning long-term application of these agents in obesity is questioned. Combined GIPR/GLP-1R agonism appears to induce fewer side effects, indicating GLP-1R/GIPR co-agonists may be more suitable for enduring obesity management. After years of debate, this GIPR-biased GLP-1R/GIPR co-agonist highlights the therapeutic promise of including GIPR modulation for diabetes and obesity therapy.

项与 CT-868 相关的新闻（医药）

2024-10-22

·微信

近半千亿药企入局，GLP-1是否市值驱动器？ | 行业观察

// · 市值超过1,000亿美元的15家大药企中，7家拥有新一代的减重产品资产； · 基于已发布的减重临床试验数据，12周、24周和48周的减重最好的药物分别是：安进的MariTide、罗氏的CT-388和礼来的retatrutide； · 口服小分子药物更适合作为快速减重后的长期维持治疗，正在成为各大药企角逐的又一个战场； · 该领域未来有可能催生大量交易。随着GLP-1药物的热度不断攀升，越来越多的公司进入这场减肥大战的同时，推高了相关药企在公开市场的市值。两款重磅GLP-1类减重产品的开发商——礼来和诺和诺德的股价也不断走高，超越强生，成为全球市值最高的两家药企。礼来和诺和诺德在公开市场上的优异表现，在医药行业掀起了一场减重产品大战，大量资本和药企冲进这一领域。据Stifel，2024 年至 2019 年间，针对减重产品的风险投资额增长了 10 倍，今年预计将超过10亿美元。而当前正在开发和已经获批的减重产品有264个。来源|CompaniesMarketcap.com，Bernstein，研发客分析，截至9月13日收盘基于9月13日的收盘价，市值超过1,000亿美元的15家大药企中，7家已经通过自研或者交易拥有了新一代的减重产品（见上图），并寄希望于这些产品能帮助公司进一步推高市值。关于交易及合作的讨论，欢迎关注第八届研发客临床年会(左右滑动查看讨论主题)。更好的激动剂出现？去年，诺和诺德的GLP-1明星产品司美格鲁肽销售额达到了212亿美元，成为全球最畅销的药物之一。公司股价也一路走高，超过100美元。五年后，礼来GLP-1/GIP受体双重激动剂替尔泊肽上市，并报告了更为强劲的减重数据。今年二季度，替尔泊肽的销售额大幅增长至43亿美元。得益于这款药物的强劲表现，礼来今年两次提高了全年的销售预期，年初至今股价上涨超过50%，成为全球市值最高的药企。患者接受GLP-1类药物治疗后一年半内的平均体重减轻情况来源|Epic Research 相比而言，诺和诺德的司美格鲁肽在二季度的销售额仅有59亿美元，其中减重品牌Wegovy销售额比市场预期低了14%，因此引发股价暴跌。尽管如此，凭借这款重磅减重产品，诺和诺德目前仍然稳居药企市值第二位。据FactSet，分析师预期到2026年，替尔泊肽的销售额将达到300亿美元，司美格鲁肽将超过400亿美元。为了获得销售持续的增长，两家公司正在投入巨资加快生产，解决供应问题。利润如此丰厚的市场，吸引了更多大玩家进入。罗氏在9月30日的Roche Pharma Day上，提到了对这个潜在价值高达1,000亿美元的大市场的兴趣。去年，罗氏以27亿美元收购Carmot Therapeutics获得了三款G蛋白偏向的GLP-1受体激动剂——CT-868、CT-388和CT-996。来源|Roche 当GLP-1和GIP受体激活剂与相关受体结合后，环磷酸腺苷 (cAMP) 信号通路被激活，但同时ß-arrestin也会被募集到受体上，然后部分通过受体运输减弱 G 蛋白信号传导，导致受体内化（receptor internalization）和脱敏（desensitization），削弱了药物疗效。为了最大限度扩大GLP-1和GIP受体激活剂的治疗窗口，Carmot 将产品设计成具有信号传导偏向性，以优先激活 cAMP，同时很少甚至没有 ß-arrestin募集，从而减少受体内化和脱敏，以延长药理活性。 5月16日，罗氏披露了CT-388（GLP-1/GIP受体双重激动剂）的1期临床研究数据。结果显示，24周时最高剂量组安慰剂调整后的体重减轻达到18.8%，当天公司股价上涨超过4%。这一数据也超过了6月恒瑞ADA上发布的同类药物HRS9531的2期24周减重数据（16.7%），以及已上市产品替尔泊肽（11.9%）和司美格鲁肽（8.0%），成为已发布24周数据中减重最多的产品。未来的市场领导者在新竞品出现的同时，减重市场领军公司也对正在研发的下一代GLP-1产品寄予厚望。在3月的资本市场日上，诺和诺德透露，在研新药CagriSema正在开展的3期减重研究包括五个子研究，计划招募1.3万名参与者，今年晚些时候将报告第一个研究的数据。此前发布的 20 周的 1 期减重试验结果显示，CagriSema可减重 17.1%，超过了司美格鲁肽的 9.8%。 CagriSema是cagrilintide（胰淀素和降钙素双重受体激动剂）和已上市药物司美格鲁肽的组合制剂。诺和诺德希望胰淀素（amylin）类似物和 GLP-1 受体激动剂的互补的机制能增强食欲抑制，实现更好的减重效果。礼来同样在做加法。去年的ADA（美国糖尿病协会）年会上，礼来发布了同时靶向GLP-1、GIP和GCG（glucagon）的新药retatrutide的2期减重研究结果。最高剂量下，48周安慰剂调整后减重22.1%，是已发布48周数据中减重最大的药物。此外，24周的安慰剂调整后减重也达到16%。安进的高管及其投资者对他们的减重药物MariTide（maridebart cafraglutide，AMG133）寄予厚望，期望MariTide能挑战两巨头的霸主地位。在5月的一季度业绩会上，公司CEO Bob Bradway暗示2期数据很好，“我们对 MariTide 这款差异化产品很有信心”。随后股价飙升了15%。在已发布12周减重数据的药物中， MariTide减重幅度最大，最高剂量组达到了16%，优于在2a期研究中表现出色的GLP-1/GIP受体双重激动剂VK2735的13周数据（13.1%）。安进目前正在开展MariTide针对超重和肥胖人群的2期研究，预计年底将发布结果。 MariTide拥有独特的机制，是一款同时靶向两个靶点的抗体-肽共轭物，抗体部分抑制GIP受体，而与抗体结合的两个GLP-1类似物可激活GLP-1受体。来源|Véniant, M.M., et al. Nat Metab 6, 290–303 (2024). 安进的机制研究表明，MariTide 能同时与 GIP 和 GLP-1的受体结合，从而触发 GLP-1受体的早期受体内化（receptor internalization），增强 GLP-1 特异性血浆和胞内体膜 cAMP 的生成，从而导致快速、显著和持续的体重减轻，且不易出现体重反弹。口服制剂：又一个战场尽管减重效果不如肽类注射剂，但口服小分子制剂生产成本低，且使用方便，更适合作为快速减重后的长期维持治疗，因此成为各大药企角逐的又一个战场。诺和诺德已经成功完成了司美格鲁肽的口服制剂的减重3期研究，但该公司更在意的是新的候选药物。其中，GLP-1/amylin受体双重激动剂amycretin（NN6487）的口服制剂。3月发布的1期研究初步结果显示，用药12周后，安慰剂调整后减重12.0%，诺和诺德股价应声大涨9%。年初，礼来的CEO David Ricks在投资者会议上提到了口服非肽类GLP-1受体激动剂orforglipron。根据去年ADA上发布的2期数据，最高剂量组下26周和36周安慰剂调整后减重分别可达到10.6%和12.4%。辉瑞的口服GLP-1受体激动剂danuglipron（PF-06882961）则命运多舛。在放弃开发代谢功能障碍相关性脂肪肝（MASH）适应症后，去年底又因为退出率超过50%而放弃了每日两次的剂型。不过，今年7月辉瑞表示，将继续开发剂量优化后的danuglipron每日一次的剂型。然而，此前每日两次剂型的2b期研究中，最高剂量组32周安慰剂调整后减重10%，相对于礼来的orforglipron并无优势。罗氏从Carmot获得的CT-996是一款小分子的GLP-1受体激动剂，根据7月发布的初步结果，这款每日一次的药物能在四周内达到安慰剂调整后6.1%。受此消息影响，罗氏股价一度上涨7%，竞争对手诺和诺德和礼来的股价则分别下跌了5%和近4%。阿斯利康同样选择从外部购入口服资产。去年11月，该公司花费1.85亿美元首付款从中国公司诚益生物获得了每日一次口服GLP-1受体激动剂ECC5004（AZD5004），目前正在开展2期研究，尚未公布数据。潜在买家有哪些为了尽快获得具有竞争力的产品，除了自主开发以外，大药企还积极开展交易。前文提到的罗氏和阿斯利康都是通过外部购买获得了减重候选药物。不过，仍有不少大药企迄今为止尚无新一代的减重产品，如强生、艾伯维、诺华、赛诺菲和BMS等。此外，默沙东的GLP-1和GCG受体双重抑制剂efinopegdutide（MK-6024）当前仅进行MASH适应症的开发，这些公司不可能放弃减重领域这个大市场，未来很可能会通过购买有竞争力的资产进入该领域。而已有资产的公司也不会停止交易。 9月初，礼来与Haya Therapeutics达成多年期合作，探索使用Haya的专有技术平台，寻找暗基因组中的长链非编码RNA（lncRNA）靶点，开发减重和代谢新药物。去年该公司还斥资19.3亿美元收购了Versanis，获得myostatin单抗bimagrumab，开发减重适应症。诺和诺德在今年1月以2.35亿欧元获得了EraCal的临床前食欲抑制剂Era-379等多款口服创新机制的口服小分子减重药物。去年8月，该公司11亿美元收购Inversago，获得的大麻素1型受体（CB1）逆激动剂monlunabant（INV-202）。另一方面，一些拥有不错数据的在研减重药物及其开发商很有可能是大药企未来的收购目标。例如，Viking的GLP-1/GIP受体双重激动剂VK2735，以及Altimmune 的 GLP-1/GCG受体双重抑制剂pemvidutide等。可喜的是，多家中国公司在今年的ADA等会议上发布的减重在研产品数据也相当不错，如甘李药业的GZR-18、恒瑞的HRS9531、先为达的伊诺格鲁肽（Ecnoglutide，XW003）等，受到海外关注。未来，或许会有大药企与中国药企的减重资产交易出现。编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2228期访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

并购申请上市引进/卖出上市批准

2024-10-09

·药渡Daily

罗氏，挺进CVRM领域

近期，罗氏在2024年医药日活动中阐述了最新药物研发进展以及未来研发的战略方向。值得注意的是，除了肿瘤、自身免疫、神经系统、眼科等传统优势业务，心血管、肾脏及代谢领域（CVRM）成为罗氏新押注的疾病领域，罗氏认为，在下一个增长周期中，CVRM将成为业绩增长的重要引擎。图1.罗氏CVRM领域在研产品管线情况资料来源：Roche Pharma Day 2024 1 Zilebesiran：长效高血压RNA干扰药物 Zilebesiran是由罗氏与Alnylam Pharmaceuticals公司共同开发的靶向血管紧张素原（AGT）的在研RNAi疗法，用于治疗未受控高血压。肾素-血管紧张素-醛固酮系统（RAAS）是高血压疾病发展的重要作用机制之一，AGT是血管紧张素的唯一前体蛋白。 Zilebesiran是由一个小干扰RNA（siRNA）与N-乙酰半乳糖胺（GalNac）配体共价链接组成。siRNA通过与靶标AGT mRNA结合，形成RNA干扰沉默复合体（RISC），肝细胞内的核酸酶能够选择性地降解RISC中的AGT mRNA，从而大幅抑制肝脏中血管紧张素原的合成，并最终导致血管紧张素的减少，同时经RISC反复循环利用而达到长效的作用。今年4月，Alnylam Pharmaceuticals公司公布了Zilebesiran在治疗轻度至中度高血压的2期临床试验KARDIA-2中取得的积极结果：将Zilebesiran与抗高血压药物联合使用，在接受治疗的第三个月，与安慰剂组相比，通过动态血压监测测量的24小时收缩压显示出具有临床意义的降低，吲达帕胺治疗组24小时动态收缩压多降低12.1mmHg。图2. Zilebesiran 2期临床试验结果资料来源：Roche Pharma Day 2024 此外，部分接受Zilebesiran治疗的患者在6个月后，在无需使用其它补救疗法的情况下，仍能维持降压效果，在吲达帕胺和氨氯地平治疗组中尤为明显。图3. Zilebesiran 2期临床试验结果资料来源：Alnylam公司官网后期，Alnylam将开展临床3期研究CVOT，旨在探索Zilebesiran治疗高血压不受控制的高危患者，研究的主要终点为主要不良心脏事件的复合终点，并探索Zilebesiran扩展其他心血管适应症的可能性。预计将于2025年下半年完成首例患者入组。 2 代谢领域：寻求差异化定位罗氏的GLP-1管线来自于收购Carmot Therapeutics公司获得。2023年12月，罗氏以27亿美金首付款和4亿美金的潜在里程碑付款收购Carmot Therapeutics公司，获得Carmot Therapeutics公司旗下3个早期肥胖症和糖尿病候选药物，分别为：一周一次皮下注射的GLP-1R/GIPR双靶激动剂CT-388；一天一次皮下注射的GLP-1R/GIPR双靶激动剂CT-868；一天一次口服给药的小分子GLP-1R激动剂CT-996。罗氏在降糖减重领域的研发进展已远远落后于两大巨头诺和诺德与礼来，珠玉在前，后入局者想要弯道超车，在激烈的市场竞争中突围，关键在于以临床未满足需求为切入点，进行差异化定位。 3 药物差异化设计：偏向性激动剂罗氏的3款GLP-1系列在研药物CT-388、CT-868、CT-996均为偏向性激动剂，即其在激活cAMP信号传导的同时，减少β-抑制蛋白（β-arrestin）活性，从而减少β-抑制蛋白介导的内吞和脱敏。根据临床前研究结果显示，减少β-抑制蛋白活性，可以延长降糖和减重疗效。图4.罗氏3款GLP-1药物的差异化设计资料来源：EASD 2024 罗氏在今年的EASD会议上公布了GLP-1/GIPR双靶点激动剂CT-388用于治疗肥胖和2型糖尿病的临床1期试验结果，数据显示，每周一次22mg的CT-388皮下注射，在治疗达到第24周时，患者体重降幅达18.9%。在第24周时，100%接受治疗的患者实现了超过5%的体重减轻，85%的患者体重降幅超过10%，70%的患者体重降幅超过15%，45%的患者体重降幅超过20%。图5. CT-388疗效数据资料来源：EASD 2024 CT-388用于治疗肥胖和2型糖尿病的2期临床试验也已开展，2024年Q3完成首例患者入组。罗氏的另一款小分子口服GLP-1受体激动剂CT-996也取得了积极的疗效数据。1期临床试验结果显示，肥胖且无2型糖尿病的患者，在接受治疗4周后，体重降幅达7.3%，安慰剂组体重降幅仅为1.2%（差异值6.1%，P＜0.001）。图6. CT-996疗效数据资料来源：EASD 2024 目前，CT-996正在进行1b期研究的第三部分研究（针对肥胖且患有2型糖尿病患者队列），2期临床试验预计将在2025年启动。 4 联合疗法应对减重“平台期”：CT-173+CT-388 减重过程中通常会遇到停滞期，罗氏希望通过CT-173与CT-388联合疗法以应对减重平台期的问题。 CT-173是一款肽YY（Peptide YY，PYY）类似物，PYY是一种由肠道内分泌细胞所产生的激素，能够起到控制食欲的作用。根据临床前研究结果显示，相较于单独使用CT-388或CT-173，CT-173和CT-388的联合治疗可以显著降低小鼠体重，在停止治疗后，联合疗法下的体重反弹速度更慢。在单独使用CT-388体重下降达到平台期后，加入CT-173，在协同作用下，体重仍能持续显著下降。罗氏预计将于2025年启动CT-388+CT-173联合疗法用于应对减重平台期的临床1期试验。图7. CT-388+CT-173临床前研究相关数据资料来源：Roche Pharma Day 2024 5 肌肉保护：GYM329 相关研究显示，使用GLP-1R药物会显著降低去脂体重，其主要成分为骨骼和肌肉。因此，能够同时实现减重效果并避免肌肉流失的新药将拥有更大的市场价值。罗氏的GYM329是一款与肌肉生长抑制素前体蛋白结合的单克隆抗体。肌肉生长抑制素是一种骨骼肌生长和强度的关键负调节因子，GYM329与肌肉生长抑制素前体蛋白的结合能够抑制它被蛋白酶激活。在临床前研究中，GYM329表现出提高肌肉大小和强度的活性。目前GYM329治疗面肩肱型肌营养不良症、脊髓性肌萎缩症的临床试验分别处于2期、2/3期阶段，治疗肥胖症的临床1期试验已启动。图8. GYM329在研项目情况资料来源：罗氏2024年H1报告近年来，罗氏的业绩表现并不乐观，传统优势领域肿瘤业务板块增长有限，老牌明星产品贝伐珠单抗、曲妥珠单抗年收入下滑幅度达两位数，罗氏的业绩支撑主要来源于创新药，例如，治疗多发性硬化的Ocrevus、治疗血友病的双抗Hemlibra等。罗氏求变，此次挺进CVRM领域，体现了罗氏将在自身的多元化布局上再下一城，以及为寻找“第二增长曲线”作战略性准备。参考资料罗氏2024年H1报告 EASD 2024 Roche Pharma Day 2024

临床2期并购临床3期siRNA信使RNA

2024-09-30

·BioSpace

Roche Doubles Down on Breast Cancer With $850M for Regor’s CDK Inhibitors

iStock, HJBC The acquisition was featured in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs. A portfolio of CDK inhibitors developed by Regor Pharmaceuticals has found a home at Roche, which announced Monday it would buy the investigational cancer drugs for $850 million upfront. Cambridge, Mass.– and China-based Regor will see two ongoing Phase I trials of CDK4 inhibitor RGT-419B through to their completion, at which time Roche’s Genentech subsidiary will take over global clinical development, manufacturing and commercialization of this asset. The deal also includes additional CDK4 inhibitors for cancer. Last December, Regor announced results from a Phase Ia trial of RGT-419B, showing that the drug was safe and well tolerated in patients with HR+/HER2- advanced breast cancer who have progressed on CDK4/6 inhibitors and endocrine therapy. “Monotherapy clinical efficacy” was also observed, Regor reported. The deal, which is expected to close in the fourth quarter of this year, includes the potential for Regor to claim additional cash payments based on the achievement of predetermined development, regulatory and commercial milestones. “Genentech is well-positioned to bring these novel therapeutics to their full potential to benefit patients with breast cancer around the world,” Xiayang Qiu, founder and CEO of Regor, said in a statement. Indeed, Roche currently markets three treatments for breast cancer: Perjeta, Kadcyla and Phesgo, which generated a combined $4.38 billion during the first half of this year. Perjeta was Roche’s third-top-selling drug in the first half. The company has a Nov. 27 PDUFA date for a fourth drug, inavolisib, for which it is seeking approval in first-line PIK3CA-mutated hormone receptor positive breast cancer. During Roche’s Pharma Day presentation in London Monday morning, CEO Teresa Graham called the Regor additions a “perfect fit” with the company’s breast cancer franchise, Endpoints News reported. In a second deal, Roche picked up Wnt signaling biotech AntlerA, gaining possession of a library of anti-FZD/LRP drug candidates. Roche is envisioning AntlerA’s lead preclinical asset as a “potential best-in-class treatment” for neovascular age-related macular degeneration and diabetic macular edema, according to Fierce Biotech . Financials were not disclosed. Another recent acquisition was in the spotlight at Roche’s Pharma Day as the company said three early-stage obesity and diabetes drug candidates stemming from its $2.7 billion buyout of Carmot Therapeutics could bring in more than $3.6 billion in annual sales. The revenue projection specifically pertains to investigational weight-loss treatment CT-388, oral GLP-1 analog CT-996 and diabetes drug CT-868, according to Reuters . In May, Roche unveiled Phase Ib data showing that CT-388 could significantly lower body weight in healthy adults with obesity. Then, in July, it announced topline data from an ongoing Phase I study showing that CT-996 could elicit “clinically meaningful” weight loss in patients with obesity but without type 2 diabetes.

临床1期并购临床结果

100 项与 CT-868 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
2型糖尿病	临床3期	美国	Carmot Therapeutics, Inc.	2022-02-22
非酒精性脂肪性肝炎	临床3期	澳大利亚	Carmot Therapeutics, Inc.	-
1型糖尿病	临床2期	美国	Carmot Therapeutics, Inc.	2023-10-19
肥胖	临床2期	美国	Carmot Therapeutics, Inc.	2022-02-22
超重	临床2期	-	Roche Holding AG	-
2型糖尿病	药物发现	墨西哥	Carmot Therapeutics, Inc.	2022-02-22
肥胖	药物发现	墨西哥	Carmot Therapeutics, Inc.	2022-02-22

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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


NCT05110846 (ADA2023) 人工标引	临床2期	2型糖尿病	103	CT-868 1.75 mg	(簾淵簾襯齋襯鏇製壓糧) = 壓襯衊鬱憲襯遞憲糧簾願窪獵鏇窪繭壓願簾積 (遞遞鹹繭築窪觸獵醖廠 ) 更多	积极	2023-10-17
				CT-868 3.25 mg	(簾淵簾襯齋襯鏇製壓糧) = 壓憲簾觸鹹夢衊夢願選願窪獵鏇窪繭壓願簾積 (遞遞鹹繭築窪觸獵醖廠 ) 更多
ADA2023	N/A	2型糖尿病肥胖	20	CT-868	簾齋築齋淵窪醖艱襯衊(網淵獵構餘築醖鬱鹹遞) = 壓築鬱襯遞顧製範願艱網遞齋積遞構遞顧構艱 (鏇築鑰築選獵繭顧積構 ) 更多	-	2023-06-20
				Placebo	簾齋築齋淵窪醖艱襯衊(網淵獵構餘築醖鬱鹹遞) = 選網窪簾製簾鏇獵壓構網遞齋積遞構遞顧構艱 (鏇築鑰築選獵繭顧積構 ) 更多