A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly s.c. Administered GL0034 in Adults with Type 2 Diabetes Mellitus Inadequately controlled on Metformin Or Diet and Exercise - SP-GL0034-02

开始日期2024-09-06

申办/合作机构

Sun Pharmaceutical Industries Ltd.

ACTRN12624000322538 / Recruiting临床1/2期

A Phase 1b/2a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy, Safety, Tolerability and the Pharmacokinetics of GL0034 (Utreglutide) in the Treatment of Non-alcoholic Fatty Liver Disease

开始日期2024-03-28

申办/合作机构-

100 项与 Utreglutide 相关的临床结果

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100 项与 Utreglutide 相关的转化医学

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100 项与 Utreglutide 相关的专利（医药）

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项与 Utreglutide 相关的文献（医药）

2022-11-01·Diabetes, obesity & metabolism

In vivo and in vitro characterization of GL0034, a novel long‐acting glucagon‐like peptide‐1 receptor agonist

Article

作者: Thorens, Bernard ; Akalestou, Elina ; Burade, Vinod ; Ramchunder, Zenouska ; Jones, Ben ; Rutter, Guy A. ; Leclerc, Isabelle ; Thennati, Rajamannar ; Tomas, Alejandra ; Manchanda, Yusman ; Piemonti, Lorenzo ; Carrat, Gaëlle ; Vilsboll, Tina ; Nguyen‐Tu, Marie‐Sophie ; Marchetti, Piero

Abstract:

Aims:

To describe the in vitro characteristics and antidiabetic in vivo efficacy of the novel glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) GL0034.

Materials and Methods:

Glucagon‐like peptide‐1 receptor (GLP‐1R) kinetic binding parameters, cyclic adenosine monophosphate (cAMP) signalling, endocytosis and recycling were measured using HEK293 and INS‐1832/3 cells expressing human GLP‐1R. Insulin secretion was measured in vitro using INS‐1832/3 cells, mouse islets and human islets. Chronic administration studies to evaluate weight loss and glycaemic effects were performed in db/db and diet‐induced obese mice.

Results:

Compared to the leading GLP‐1RA semaglutide, GL0034 showed increased binding affinity and potency‐driven bias in favour of cAMP over GLP‐1R endocytosis and β‐arrestin‐2 recruitment. Insulin secretory responses were similar for both ligands. GL0034 (6 nmol/kg) led to at least as much weight loss and lowering of blood glucose as did semaglutide at a higher dose (14 nmol/kg).

Conclusions:

GL0034 is a G protein‐biased agonist that shows powerful antidiabetic effects in mice, and may serve as a promising new GLP‐1RA for obese patients with type 2 diabetes.

2019-01-01·Applied microbiology and biotechnology3区 · 工程技术

Stimulatory effects of novel glucosylated lactose derivatives GL34 on growth of selected gut bacteria

3区 · 工程技术

Article

作者: Boger, Markus C L ; Dijkhuizen, Lubbert ; Pham, Hien T T ; van Leeuwen, Sander S

Previously we structurally characterized five glucosylated lactose derivatives (F1-F5) with a degree of polymerization (DP) of 3-4 (GL34), products of Lactobacillus reuteri glucansucrases, with lactose and sucrose as substrates. Here, we show that these GL34 compounds are largely resistant to the hydrolytic activities of common carbohydrate-degrading enzymes. Also, the ability of single strains of gut bacteria, bifidobacteria, lactobacilli, and commensal bacteria, to ferment the GL34 compounds was studied. Bifidobacteria clearly grew better on the GL34 mixture than lactobacilli and commensal bacteria. Lactobacilli and the commensal bacteria Escherichia coli Nissle and Bacteroides thetaiotaomicron only degraded the F2 compound α-D-Glcp-(1 → 2)-[β-D-Galp-(1 → 4)-]D-Glcp, constituting around 30% w/w of GL34. Bifidobacteria digested more than one compound from the GL34 mixture, varying with the specific strain tested. Bifidobacterium adolescentis was most effective, completely degrading four of the five GL34 compounds, leaving only one minor constituent. GL34 thus represents a novel oligosaccharide mixture with (potential) synbiotic properties towards B. adolescentis, synthesized from cheap and abundantly available lactose and sucrose.

2018-12-01·Carbohydrate research4区 · 化学

Structural characterization of glucosylated GOS derivatives synthesized by the Lactobacillus reuteri GtfA and Gtf180 glucansucrase enzymes

4区 · 化学

Article

作者: Dijkhuizen, Lubbert ; van Leeuwen, Sander S ; Pham, HienT T

β-Galacto-oligosaccharides (GOS) are used commercially in infant nutrition, aiming to functionally replace human milk oligosaccharides (hMOS). Glucansucrases Gtf180-ΔN and GtfA-ΔN of Lactobacillus reuteri strains convert sucrose into α-glucans with (α1→6)/(α1→3) and (α1→4)/(α1→6) glucosidic linkages, respectively. Previously we reported that both glucansucrases glucosylate lactose, producing a minimum of 5 compounds (degree of polymerization 3-4) (GL34 mixture) with (α1→2/3/4) linkages. This GL34 mixture exhibited growth stimulatory effects on various probiotic bacteria. Aiming to obtain additional compounds mimicking hMOS in structure and function, we here studied glucosylation of 3 commercially available galactosyl-lactose GOS compounds. Both Gtf180-ΔN and GtfA-ΔN were unable to use 3'-galactosyl-lactose (β3'-GL), but used sucrose to add a single glucose moiety to 4'-galactosyl-lactose (β4'-GL) and 6'-galactosyl-lactose (β6'-GL). β6'-GL was elongated at its reducing glucosyl unit with an (α1→2)-linked moiety and at its non-reducing end with an (α1→4) linked moiety; β4'-GL was only elongated at its reducing end with an (α1→2) linked moiety. Glucansucrases Gtf180-ΔN and GtfA-ΔN thus can be used to produce galactosyl-lactose-derived oligosaccharides containing (α1→2) and (α→4) glucosidic linkages, potentially with valuable bioactive (prebiotic) properties.

项与 Utreglutide 相关的新闻（医药）

2024-06-24

·生物谷

“减肥神药”司美格鲁肽专利即将到期，中印仿制药蓄势待发，更便宜的减肥药就快来了

2014年，美国食品药品监督管理局（FDA）批准了第一个用于减肥的GLP-1类药物——利拉鲁肽，这是一种人工合成酰化GLP-1类似物。近年来，司美格鲁肽风靡全球，这款胰高血糖素样肽-1（GLP-1）受体激动剂类药物，让我们见识到了减肥还可以如此简单。这款药物去年销售额超过200亿美元，也帮助其开发公司诺和诺德的股价一路攀升，目前总市值超过6300亿美元。而由于中国和印度的许多制药公司的努力，司美格鲁肽等重磅减肥药可能很快就会变得更便宜，从而惠及更广泛的人群。 2024年2月，《柳叶刀》发表的最新数据显示，全世界肥胖总人数已经达到10亿，作为全世界人口最多的两个国家，中国和印度有着数以亿计的肥胖和超重人口，他们对减肥药的需求的很强劲。模拟激素，高效减肥在过去的几年里，一类新型减肥药快速风靡全球，它们通过模拟一种天然产生激素——胰高血糖素样肽-1（GLP-1）来发挥作用。GLP-1不仅调节血糖水平，还与大脑中控制食欲的受体和肠道中减缓消化并产生饱腹感的受体结合。 2014年，美国食品药品监督管理局（FDA）批准了第一个用于减肥的GLP-1类药物——利拉鲁肽，这是一种人工合成酰化GLP-1类似物，与人体天然GLP-1相比具有97%以上的序列相似性，该药物每天皮下注射一次，一年内可使体重平均减轻8%。这种给药频率和减肥效果，显然还不具备风靡全球的要求，直到7年后，司美格鲁肽惊艳亮相。 2021年，美国FDA批准司美格鲁肽作为减肥药上市，这种新一代GLP-1类药物，每周皮下注射一次，可使体重平均减轻15%。 2023年，美国FDA替尔泊肽作为减肥药上市，这是首款GLP-1和GIP受体双重激动剂，每周皮下注射一次，可使体重平均减轻22.5%。这些GLP-1类药物，不仅能够治疗2型糖尿病、减肥，还能够降低肾衰竭的风险、抑制炎症、预防严重心血管疾病发作、减轻睡眠呼吸暂停综合症等等。中印仿制药蓄势待发 GLP-1类药物减肥效果很好，但它们的价格也确实不低，以美国价格为例，使用司美格鲁肽或替尔泊肽减肥的肥胖患者，一个月的费用可能要超过1000美元。目前，利拉鲁肽的专利在中国已经过期，而司美格鲁肽的专利也将于2026年在中国和印度过期，来自印度和中国的公司计划通过开发生物仿制药来大幅降低这些GLP-1类药物的高昂价格。这些生物仿制药的成本会降低多少还有待观察，但售价很可能将至原研药的一半甚至十分之一。大幅降低的售价，可能会让更多人使用，从而扩大需求，这反过来也会产生连锁反应，加大竞争，带来更低廉的售价。印度目前尚未批准任何减肥生物仿制药，但一家位于印度孟买的制药公司Glenmark Pharmaceuticals在今年1月份推出了一款利拉鲁肽生物仿制药——Lirafit，用于治疗2型糖尿病，该药物每天只需花费约1.2美元，相比利拉鲁肽便宜了70%。此外，印度仿制药巨头Biocon也开发了利拉鲁肽和司美格鲁肽的生物仿制药，正在等待上市。而在中国，中国药监局已经批准了两款由中国公司生产的用于减肥的GLP-1类药物，第一款是华东医药生产的利拉鲁肽生物仿制药（商品名为利鲁平）；第二款是仁会生物生产的贝那鲁肽（商品名为菲塑美），贝那鲁肽是首款全人源GLP-1药物，其与人体生理性GLP-1的氨基酸序列完全一致，未做修饰，因此半衰期短，需要一天三次皮下注射给药。此外，中国已有几家公司准备在2026年司美格鲁肽在中国的专利到期后抢占市场。有6家公司已经启动了司美格鲁肽的3期临床试验，其中九源基因的司美格鲁肽生物仿制药已完成治疗2型糖尿病的3期临床试验，有望率先进入中国市场。此外，该公司也已经启动了司美格鲁肽生物仿制药治疗肥胖的3期临床试验。九源基因的部分在研管线随着司美格鲁肽生物仿制药的到来，减肥市场的游戏规则有望再次改写，市场竞争也会变得尤为激烈。除了仿制，还有改进除了生物仿制药，印度和中国的制药公司也在开发新型减肥药物。例如，位于印度孟买的Sun Pharmaceuticals开发了一种名为GL0034的分子，其化学结构相比司美格鲁肽略有调整，并改变了它与胰岛素分泌细胞和神经细胞的相互作用的方式，从而希望产生出更便宜且媲美司美格鲁肽效果的减肥药。早期临床试验结果显示，高剂量组的使用者在2个月内体重减轻了10%。此外，该公司也在开发与替尔泊肽竞争的全新结构的双靶点减肥药。在中国，信达生物与礼来合作开发的新型双靶点减肥药玛仕度肽（Mazdutide）有望更早在中国上市，这是一款胰高血糖素样肽-1（GLP-1）/胰高血糖素（GCG）受体双重激动剂，胰高血糖素（GCG）有助于促进新陈代谢，促进脂肪组织燃烧。此前公布的2期临床试验结果显示，其减肥效果媲美司美格鲁肽，9mg剂量组在平均BMI=34.3的中国肥胖人群中治疗24周后的减重幅度可达15.4%。而在下周，信达生物将在美国糖尿病协会年会上公布3期临床试验数据，据悉，9mg剂量组在近一年后体重减轻了高达19%。据预计，玛仕度肽将在2025年上半年获得中国药品监管机构的批准用于减肥，这将使其成为全球首个获批的GLP-1、GCG双靶点减肥药。

专利到期

2024-06-22

·PRNewswire

Sun Pharma's GL0034 (Utreglutide) Demonstrates Significant Weight Loss, Gluco-metabolic and Lipid Lowering Efficacy in Individuals with Obesity in Oral Presentation at the American Diabetes Association 84th Scientific Sessions

GL0034 administered once-weekly confirmed clinically meaningful weight loss and improved gluco-metabolic parameters over a 4-week treatment period in individuals with obesity, even in the lowest dosing regimen. GL0034 demonstrated gluco-metabolic activity and reductions in lipid levels, including triglycerides, total cholesterol, and non-HDL cholesterol, suggesting novel and beneficial effects on lipid metabolism. GL0034 exhibited a favorable tolerability profile, with gastrointestinal (GI) adverse events consistent with those typically observed in the incretin class. These findings highlight GL0034's potential as a therapeutic option for individuals with obesity, providing not only weight loss but also improvements in key cardiometabolic biomarkers. MUMBAI, India and NEW YORK, June 22, 2024 /PRNewswire/ --Sun Pharmaceutical Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715) (together with its subsidiaries and/or associates referred as "Sun Pharma") announced results from a Phase 1, multiple ascending-dose study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of GL0034 (Utreglutide) in obese adults. The data was exhibited in an oral presentation at the 84th Scientific Sessions of the American Diabetes Association (ADA), on June 21, 2024, in Orlando, FL. Obesity is a rapidly growing global health concern, contributing to numerous metabolic disorders, including type 2 diabetes mellitus (T2DM), cardiovascular diseases, and metabolic dysfunction-associated steatohepatitis (MASH). Effective treatments are crucial for managing obesity and its associated comorbidities. GLP-1 (glucagon-like peptide-1) receptor agonists have emerged as a promising therapeutic class for obesity. GL0034 (Utreglutide) is a novel differentiated incretin analogue with potent, long-acting agonist activity at the GLP-1 receptor. This innovative compound is under evaluation for its potential to provide significant clinical benefits beyond weight loss and gluco-metabolic benefits in individuals with obesity. "The recent GL0034 study has shown encouraging results with significant weight loss and notable improvements in lipid profiles among obese participants," said Richard E. Pratley, MD, Medical Director, AdventHealth Diabetes Institute and Senior Investigator, Diabetes Program Lead, Translational Research Institute. "This investigational therapy stands out as a potentially differentiated asset in the weight management field. The positive outcomes emphasize the potential of this treatment and set the stage for further research and development." "The promising data from our GL0034 study highlights our commitment to addressing the growing global health challenge of obesity. These findings not only demonstrate the activity of GL0034 in promoting weight loss but also underscore its potential in improving crucial cardiometabolic parameters and risk factors," said Dilip Shanghvi, Managing Director, Sun Pharma. "We are dedicated to advancing this innovative therapy to bring meaningful benefits to patients worldwide." GL0034 Oral Presentation at the ADA 2024 Scientific Sessions Safety, Tolerability, and Metabolic Effects of Once-Weekly GL0034 (Utreglutide) in Individuals with Obesity—A Multiple Ascending Dose Study. [Oral Presentation #121-OR, Friday, June 21, 2024, 05:00pm-5:15pm ET, W415C (Valencia Ballroom), Presented by Dr. Rajamannar Thennati] Healthy, obese male participants (n=24; Age 18-40; BMI ≥ 28 kg/m²) were enrolled into a fixed-dose Cohort 1 (4 x 680 µg) or an increasing-dose Cohort 2 (680/900/1520/2000 µg) and assigned to treatment groups in a 3:1 ratio, receiving 4 weekly doses of either GL0034 or a placebo. An oral glucose tolerance test (OGTT) was performed on Day -1 (baseline) and Day 23 (after the 4th dose). The results were as follows: Significant body weight reduction was observed from baseline at Day 29 and persisted through Day 43 in treatment cohorts compared to placebo. - Absolute weight loss change of –4.6 ± 1.5 (P<0.001) in Cohort 2. Both cohorts showed significant reductions in glucose AUC0-120 min during OGTT on Day 23 and dose-dependent insulin AUC0-120 min reductions, suggesting improved insulin sensitivity. HbA1c, leptin levels, and lipid levels (triglycerides, total cholesterol, non-HDL cholesterol) were reduced in the treatment cohorts. GL0034 was well-tolerated with no treatment-related discontinuations. The most common adverse events were gastrointestinal, consistent with the incretin class profile. The study was conducted in Belgium. The accumulating evidence suggests that GL0034 has a potentially differentiated profile in the evolving landscape of obesity treatment. The Phase 1 study results have demonstrated clinically meaningful weight loss, significant metabolic improvements, and a favorable tolerability profile. Notably, GL0034 has shown a novel ability to lower lipid profiles, especially triglycerides, suggesting an additional therapeutic benefit that sets it apart from other treatments. As a selective GLP-1 receptor agonist, GL0034 shows potential for enhanced therapeutic benefits. "The significant weight loss and metabolic improvements observed with GL0034 strongly support the further clinical evaluation of this novel GLP-1 receptor agonist for treating obesity, type 2 diabetes, metabolic dysfunction-associated steatohepatitis, and other weight-related comorbidities. To confirm these benefits, we will conduct larger, randomized controlled studies to fully elucidate the therapeutic potential of GL0034 for patients," said Rajamannar Thennati, MD, Lead Investigator and Executive Vice President, Research & Development, Sun Pharma. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050) Sun Pharma is a leading global specialty generics company with presence in Innovative products, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on "X" @SunPharma_Live. Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Logo - SOURCE Sun Pharmaceutical Industries Limited

临床结果临床1期

2023-06-29

·药明康德

可同时减重、降血脂血糖的小分子疗法；8周最高减重10.7%的GLP-1受体激动剂... | 一周盘点

▎药明康德内容团队编辑本期看点1. 新型胰高血糖素样肽1（GLP-1）受体激动剂GL0034的早期临床结果亮眼，健康受试者接受每周一次的治疗，8周最高减重10.7%。2. 用于治疗代谢综合征及其相关并发症的小分子CB1受体阻滞剂INV-202在28天的治疗期内使受试者的体重平均下降7斤，血脂和血糖控制指标也有所改善。3. 具有功能性治愈糖尿病潜力的干细胞疗法VX-880公布新临床试验数据，所有6名接受VX-880治疗的患者产生了内源性胰岛素，血糖控制得到了改善，同时减少或免除了胰岛素的使用。药明康德内容团队整理GL0034：公布首次人体试验的初步数据Sun Pharmaceutical Industries公司公布了其新型胰高血糖素样肽1受体（GLP-1R）激动剂GL0034的首次人体试验的初步数据。GL0034旨在作为一种每周一次的长效抗糖尿病药物，治疗2型糖尿病和肥胖患者。此次公布的两项试验的结果显示，GL0034在受试者中的耐受性良好。在其中一项研究中，无糖尿病的肥胖患者在接受单次用药后的第8天就观察到了甘油三酯水平和体重的下降。在另一项研究中，体重正常的健康受试者每周接受较低剂量的GL0034一次，持续8周，在GL0034治疗4至8周后，观察到受试者出现明显的剂量依赖性体重下降，最高达10.7%。在这些研究中，最常见的不良事件（任何剂量组中≥5名受试者）包括恶心、呕吐、食欲下降、早期饱食和消化不良。INV-202：公布1b期临床试验数据Inversago Pharma公司公布了其小分子CB1受体阻滞剂INV-202用于治疗代谢综合征及其相关并发症的1b期临床试验数据。INV-202旨在优先阻断肾脏、胃肠道、肝脏、胰腺、脂肪组织、肌肉、肺和其他外周组织中的CB1受体，从而治疗一系列心脏代谢疾病，包括糖尿病肾病。此次公布的结果显示，在28天的治疗期内，INV-202在具有代谢综合征特征的受试者中具有良好的安全性、耐受性、药代动力学和药效学作用。接受INV-202治疗的受试者显示出临床上显著的、渐进的体重下降，平均下降3.5公斤，而服用安慰剂的受试者的体重平均增加了0.55公斤（P<0.01）。此外，接受INV-202治疗的受试者相较于接受安慰剂的受试者在血脂和血糖控制方面也展现出积极的趋势，包括糖化血红蛋白（HbA1c）、甘油三酯和低密度脂蛋白胆固醇的降低。VX-880：公布1/2期临床试验数据Vertex Pharmaceuticals公司公布了其来源于干细胞的全分化胰岛细胞替代疗法VX-880在1/2期临床试验中获得积极数据。VX-880是一种来源于同种异体干细胞的全分化胰岛细胞疗法，有可能通过恢复胰岛细胞功能，包括葡萄糖反应性胰岛素的产生，来恢复机体调节葡萄糖水平的能力。VX-880通过肝门静脉输注给药，需要与慢性免疫抑制疗法联用来保护胰岛细胞免受免疫排斥。此次公布的数据显示，所有6名接受VX-880治疗的患者产生了内源性胰岛素，血糖控制得到了改善，同时减少或免除了胰岛素的使用。两名随访至少一年的患者符合主要终点的标准，即不再发生严重低血糖事件（SHE），HbA1c<7.0%。此外，这两名患者不再依赖外源胰岛素治疗，HbA1c值分别为5.3%和6.0%。截至目前，VX-880在所有患者中的耐受性良好。AMT-130：公布1/2期临床试验的新数据uniQure公司公布了其在研基因疗法AMT-130在治疗亨廷顿病（Huntington’s disease）的1/2期临床试验中获得积极初步结果。AMT-130是uniQure首个聚焦中枢神经系统的基因疗法，由AAV5载体携带专门沉默HTT基因表达的微RNA（microRNA），利用该公司专有的miQURE沉默技术，抑制突变亨廷顿蛋白的产生。在这项试验中，研究人员利用核磁共振（MRI）成像引导，将基因疗法直接注射到大脑的壳核和尾状核中。这是一种将基因疗法精准递送到中枢神经系统的技术。此次公布的结果显示，与基线时相比，接受AMT-130治疗的患者的功能得到了维持，与疾病自然史相比具有临床益处。脑脊液中的神经纤维蛋白轻链（NfL）水平是代表神经元损伤的关键生物标志物之一。在接受低剂量AMT-130治疗的患者中，NfL在24个月时降低至基线下；接受高剂量AMT-130治疗的患者，NfL在12个月时向基线下降。在低剂量队列中，患者脑脊液中的突变亨廷顿蛋白（mHTT）水平被抑制，高剂量队列中，这种抑制作用更强。NY-ESO-1 TCR/IL-15 NK：IND申请获得FDA许可NY-ESO-1 TCR/IL-15 NK是由Syena公司开发的工程化的T细胞受体自然杀伤（TCR-NK）细胞疗法，用于晚期滑膜肉瘤和粘液样/圆细胞脂肪肉瘤。该疗法使用源自脐带血的细胞，因此具潜力提供现货型、规模化的细胞疗法以治疗癌症。TCR-NK细胞疗法将工程化的TCR疗法与NK细胞结合，以改善其安全性与疗效。基于嵌合抗原受体（CAR）的疗法仅能辨认细胞表面的蛋白抗原，而TCR疗法则能辨认细胞内部的蛋白。将TCR与NK细胞结合使得细胞能够辨认由细胞表面免疫蛋白所呈现的外化蛋白片段。因此TCR-NK细胞疗法具潜力靶向范围更广的肿瘤抗原。该疗法的1/1b期临床试验计划于2023年第三季度启动。BI-1808：公布1/2a期临床试验的中期数据BioInvent International公司公布了其抗TNFR2抗体BI-1808用于治疗晚期恶性肿瘤的1/2a期试验的中期数据。TNFR2在肿瘤微环境的Treg细胞表面高表达，已被证明对肿瘤的生长和存活很重要，是癌症免疫疗法的一个新的有前途的靶点。此次公布的研究数据显示，BI-1808的安全性和耐受性良好，未观察到严重的不良事件或剂量限制性毒性。截至目前，22名可评估的患者中有6名达到了疾病稳定（SD）。Darovasertib（IDE196）：公布1期临床试验中首位患者的数据IDEAYA Biosciences公司公布了其在研蛋白激酶C（PKC）小分子抑制剂IDE196作为新辅助疗法在首位葡萄膜黑色素瘤（UM）患者中的病例报告。在这名UM患者中，darovasertib作为单一疗法进行新辅助治疗4个月后，肿瘤的大小缩小了24%，使患者免于接受眼球摘除手术。Itruvone（PH10）：公布1期临床试验数据Vistagen公司公布了其用于治疗抑郁症的在研鼻喷雾剂itruvone的积极早期数据。Itruvone鼻喷雾剂以微克级剂量施用，旨在结合和激活与大脑神经回路相连的鼻腔通道中的化学感觉神经元，从而产生抗抑郁作用。该候选疗法不需要全身摄取或脑渗透即可快速起效，从而有别于目前所有获批的口服抗抑郁药和快速起效的基于氯胺酮的治疗（KBT），有望避免与KBT和长效口服抗抑郁药有关的副作用和安全问题。此次公布的结果显示，itruvone的安全性和耐受性良好。AG-80308：公布1b期临床试验的初步数据Allgenesis Biotherapeutics公司公布了其用于治疗干眼病的甲酰肽受体（FPR）激动剂AG-80308在早期临床试验中的初步数据。该临床试验在84名干眼症患者中测试了不同种配方和浓度的AG-80308制剂。患者每天用药两次，持续3个月。结果显示，AG-80308在所有测试剂量下都被认为是安全的。患者在体征和症状方面都有改善，包括角膜染色、结膜染色、泪液分泌反应、干眼症不适、眼干、灼热/刺痛、瘙痒、异物感、畏光和疼痛。CHK-336：公布1期临床试验的初步数据Chinook Therapeutics公司公布了其用于治疗原发性高草酸尿症和其他肾结石疾病的口服小分子LDHA抑制剂CHK-336在健康受试者中的安全性、耐受性和药代动力学特征。1期临床试验结果显示，CHK-336通常耐受性良好，具有良好的药代动力学特征，其半衰期支持每日一次的给药频率。此外，研究人员利用新型示踪剂证明了CHK-336能够阻断健康受试者肝脏草酸盐的生成。EP262：公布1期临床试验数据Escient Pharmaceuticals公司公布了其潜在“first-in-class”的MRGPRX2受体小分子拮抗剂EP262的积极早期数据。MRGPRX2是一种在屏障组织（例如皮肤、气道、胃肠道）中发现的，并在肥大细胞上表达的受体。该受体激活会导致肥大细胞脱颗粒并释放组胺、类胰蛋白酶、糜蛋白酶、趋化因子和细胞因子，这会导致荨麻疹、血管性水肿、慢性瘙痒和疼痛等疾病。通过阻断MRGPRX2的激活，EP262有潜力治疗范围广泛的肥大细胞介导的疾病。此次公布的数据显示，EP262在所有测试剂量下都是安全且耐受性良好的，药代动力学特征支持每日一次口服给药。EDP-323：公布1期临床试验数据Enanta Pharmaceuticals公司公布了其用于治疗呼吸道合胞病毒（RSV）感染的新型口服L蛋白抑制剂EDP-323的积极早期数据。结果显示，800 mg剂量下连续7天给药EDP-323在健康受试者中的耐受性良好，药代动力学特征支持每天一次的给药频率。此外，所有剂量下EDP-323的暴露倍数（exposure multiples）均良好，支持EDP-323开展进一步的临床研究。VTP-300：公布1b/2期临床试验数据Vaccitech Limited公司宣布其针对慢性乙型肝炎（HBV）感染者的候选疫苗VTP-300在1b/2a期临床试验中达到了主要和次要终点。VTP-300是一种与疫苗作用机制非常类似的免疫疗法，利用Vaccitech的黑猩猩腺病毒载体（ChAdOx1）和改良牛痘安卡拉病毒（MVA）载体表达乙肝病毒抗原，激发抗HBV的免疫应答，有望为慢性乙肝患者带来功能性治愈。此次公布的数据显示，在单独接受VTP-300和与低剂量PD-1抑制剂联合使用的受试者中，观察到乙型肝炎表面抗原（HBsAg）显著、持久的降低。2名患者已检测不到HBsAg，在最后一次给药后维持了8个月。此外，VTP-300产生了强大的T细胞反应，这种反应在单独接受VTP-300的受试者中最高。大家都在看▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息参考资料（可上下滑动查看）[1] Vaxxinity Announces UB-312 Successfully Met Primary Objectives of Phase 1 Clinical Trial in Parkinson’s Disease. Retrieved June 26, 2023, from https://ir.vaxxinity.com/news-releases/news-release-details/vaxxinity-announces-ub-312-successfully-met-primary-objectives[2] Jasper Therapeutics Announces First Patient Dosed in a Phase 1 Trial of Briquilimab in Lower-Risk Myelodysplastic Syndrome. Retrieved June 26, 2023, from https://ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-announces-first-patient-dosed-phase-1-trial[3] CureVac Doses First Patient in Phase 1 Study of Cancer Vaccine Candidate for Surgically Resected Glioblastoma. Retrieved June 26, 2023, from https://www.accesswire.com/762253/CureVac-Doses-First-Patient-in-Phase-1-Study-of-Cancer-Vaccine-Candidate-for-Surgically-Resected-Glioblastoma[4] Accutar Biotechnology Announces First Patient Dosed with AC0676 in Phase 1 Study in Patients with Relapsed/Refractory B-cell Malignancies. Retrieved June 26, 2023, from https://www.businesswire.com/news/home/20230620086924/en[5] Delix Therapeutics Announces Completion of 1st Cohort Dosing, Dose Escalation Approval in Phase I Trial for Novel Compound DLX-001. Retrieved June 26, 2023, from https://www.prnewswire.com/news-releases/delix-therapeutics-announces-completion-of-1st-cohort-dosing-dose-escalation-approval-in-phase-i-trial-for-novel-compound-dlx-001-301853647.html[6] Chinook Therapeutics Presents Data from CHK-336 Phase 1 Trial in Healthy Volunteers and New Insights into the Role of Failed Repair in Chronic Kidney Disease at the 60th European Renal Association (ERA) Congress. Retrieved June 26, 2023, from https://www.globenewswire.com/news-release/2023/06/17/2689976/35377/en/Chinook-Therapeutics-Presents-Data-from-CHK-336-Phase-1-Trial-in-Healthy-Volunteers-and-New-Insights-into-the-Role-of-Failed-Repair-in-Chronic-Kidney-Disease-at-the-60th-European-R.html[7] Allgenesis Announces Encouraging Phase 1b Data Showing AG-80308 Providing Improvements in Multiple Signs and Symptoms in Dry Eye Patients. Retrieved June 26, 2023, from https://www.prnewswire.com/news-releases/allgenesis-announces-encouraging-phase-1b-data-showing-ag-80308-providing-improvements-in-multiple-signs-and-symptoms-in-dry-eye-patients-301853236.html[8] Replay and MD Anderson announce FDA clearance of IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for sarcoma. Retrieved June 26, 2023, from https://www.globenewswire.com/news-release/2023/06/20/2690890/0/en/Replay-and-MD-Anderson-announce-FDA-clearance-of-IND-application-for-first-in-class-T-Cell-Receptor-Natural-Killer-TCR-NK-cell-therapy-for-sarcoma.html[9] ZSun Pharma Presents Data from First-in-Human Phase 1 Studies of GL0034 at the American Diabetes Association 83rd Scientific Sessions. Retrieved June 26, 2023, from https://www.prnewswire.com/news-releases/sun-pharma-presents-data-from-first-in-human-phase-1-studies-of-gl0034-at-the-american-diabetes-association-83rd-scientific-sessions-301861402.html [10] Sun Pharma Presents Data from First-in-Human Phase 1 Studies of GL0034 at the American Diabetes Association 83rd Scientific Sessions. Retrieved June 26, 2023, from https://www.prnewswire.com/news-releases/sun-pharma-presents-data-from-first-in-human-phase-1-studies-of-gl0034-at-the-american-diabetes-association-83rd-scientific-sessions-301861402.html[11] Inversago Pharma Presents Data from Phase 1b Trial of INV-202, a Peripheral CB1r Blocker for Metabolic Syndrome, at the 83rd American Diabetes Association Scientific Sessions. Retrieved June 26, 2023, from https://www.businesswire.com/news/home/20230623384277/en[12] Vertex Presents Positive VX-880 Results From Ongoing Phase 1/2 Study in Type 1 Diabetes at the American Diabetes Association 83rd Scientific Sessions. Retrieved June 26, 2023, from https://www.businesswire.com/news/home/20230623446641/en[13] Vistagen Announces Results of Successful U.S. Phase 1 Study of Itruvone (PH10), Enabling U.S. Phase 2B Development for Treatment of Major Depressive Disorder. Retrieved June 26, 2023, from https://www.businesswire.com/news/home/20230621794406/en[14] BioInvent Reports Strong Interim Safety Data and Early Signs of Efficacy in Phase 1/2a Trial with anti-TNFR2 Antibody BI-1808 in Advanced Malignancies. Retrieved June 26, 2023, from https://www.accesswire.com/762658/BioInvent-Reports-Strong-Interim-Safety-Data-and-Early-Signs-of-Efficacy-in-Phase-12a-Trial-with-anti-TNFR2-Antibody-BI-1808-in-Advanced-Malignancies[15] Enanta Pharmaceuticals Announces Positive Data From a Phase 1 Clinical Study of EDP-323, an Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus. Retrieved June 26, 2023, from https://www.businesswire.com/news/home/20230620911346/en[16] Escient Pharmaceuticals Announces Positive Results from Phase 1 Study of EP262, a First-in-Class Oral MRGPRX2 Antagonist for Mast Cell Mediated Disorders. Retrieved June 26, 2023, from https://www.businesswire.com/news/home/20230620558373/en[17] IDEAYA Announces First Reported Case of Uveal Melanoma Patient Spared Enucleation in Phase 1 Neoadjuvant IST with Darovasertib Monotherapy. Retrieved June 26, 2023, from https://www.prnewswire.com/news-releases/ideaya-announces-first-reported-case-of-uveal-melanoma-patient-spared-enucleation-in-phase-1-neoadjuvant-ist-with-darovasertib-monotherapy-301857515.html[18] uniQure Announces Update on U.S. Phase I/II Clinical Trial of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease. Retrieved June 26, 2023, from https://www.uniqure.com/investors-media/press-releases[19] Vaccitech to Present Positive Final Data at EASL Congress for Phase 1b/2 HBV002 Study in Adults with Chronic Hepatitis B. 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临床结果细胞疗法临床1期临床2期

100 项与 Utreglutide 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1期	-	Sun Pharmaceutical Industries Ltd.	2023-06-24
肥胖	临床1期	-	Sun Pharmaceutical Industries Ltd.	2023-06-24

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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


ACTRN12624000322538 (ADA2024) 人工标引	临床1期	肥胖	12	GL0034 (Utreglutide) (cohort 1)	廠網鹽壓網鑰選鑰積膚(願鹹鏇積築鬱廠網製憲) = 鏇獵網膚糧窪獵壓齋簾築餘顧蓋範遞夢艱糧願 (醖壓廠憲願窪網餘觸醖, 1.7)	积极	2024-06-14
				GL0034 (Utreglutide) (cohort 2)	廠網鹽壓網鑰選鑰積膚(願鹹鏇積築鬱廠網製憲) = 淵獵鹽醖淵製鏇淵選鹽築餘顧蓋範遞夢艱糧願 (醖壓廠憲願窪網餘觸醖, 1.5)
EASD2023	临床1期	肥胖	24	Utreglutide 2,520 µg	艱遞蓋積築淵觸築選憲(顧齋製壓蓋選鏇艱構醖) = The common utreglutide-related adverse events were gastrointestinal with dose-dependent nausea, decreased appetite and vomiting. No injection site reactions or any other adverse events were noted. 窪艱網製襯範鑰膚襯餘 (憲願構艱鑰範鬱蓋鹹鹽 ) 更多	积极	2023-10-03
ADA2023	N/A	肥胖	24	GL0034 (Utreglutide) 1,520 μg	鏇淵範遞壓襯齋餘齋膚(衊壓繭襯製餘積淵繭遞) = Most common GL-related adverse events were gastrointestinal with dose-dependent nausea, decreased appetite and vomiting 鹽鏇憲遞膚構廠窪範簾 (窪鑰醖壓餘遞顧膚淵築 ) 更多	积极	2023-06-20
				GL0034 (Utreglutide) 2,000 μg