A Two-Part First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GUB014295 in Lean to Overweight or Obese But Otherwise Healthy Men and Women

This is a two-part, single centre, double-blind (within cohorts), randomised, placebo-controlled, single (Part 1) and multiple (Part 2) ascending subcutaneous dose study in lean to overweight or obese but otherwise healthy men (Part 1) and men and non-pregnant, non-lactating women (Part 2). The primary objective is to assess the safety and tolerability. Secondary objectives are to characterize the pharmacokinetics (PK) and to investigate pharmacodynamic effects.

开始日期2023-11-29

申办/合作机构

Gubra A/S

[+1]

ISRCTN85112396 / Recruiting临床1期

A first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of GUB014295 in lean to overweight or obese but otherwise healthy men

开始日期2023-11-15

申办/合作机构

Gubra A/S

100 项与 GUB-014295 相关的临床结果

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100 项与 GUB-014295 相关的转化医学

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100 项与 GUB-014295 相关的专利（医药）

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项与 GUB-014295 相关的文献（医药）

2024-09-01·Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Incretin hormone agonists: Current and emerging pharmacotherapy for obesity management

Review

作者: Brown, Roy ; Talasaz, Azita H. ; Chandrasekaran, Preethi ; Mehta, Anurag ; Dixon, Dave L. ; Alhomoud, Ibrahim S.

AbstractObesity continues to be a significant global health challenge, affecting over 800 million individuals worldwide. Traditional management strategies, including dietary, exercise, and behavioral interventions, often result in insufficient and unsustainable weight loss. Lifestyle modification remains the cornerstone of obesity management, providing the foundation for other strategies. While options such as bariatric surgery remain an effective intervention for severe obesity, it is associated with its own set of risks and is typically reserved for patients who have not achieved the desired results with pharmacotherapy and lifestyle interventions. Incretin hormone agonists represent a significant advancement in the pharmacotherapy of obesity, offering substantial weight reduction and cardiometabolic benefits. Agents like liraglutide, semaglutide, and tirzepatide supported by key clinical trials such as Satiety and Clinical Adipose Liraglutide Evidence (SCALE), Semaglutide Treatment Effect in People with Obesity (STEP) program trials, and Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT‐1) have demonstrated remarkable efficacy in promoting weight loss and improving metabolic outcomes. Additionally, novel therapies, including dual and triple incretin agonists, are under investigation and hold the potential for further advancements in obesity treatment. These novel therapies can be categorized by their mechanisms of action and route of administration into oral glucagon‐like peptide‐1 (GLP‐1) receptor agonists, triple agonists (targeting GLP‐1, glucose‐dependent insulinotropic polypeptide [GIP], and glucagon receptors), and glucagon receptor‐GLP‐1 receptor co‐agonists. Other innovative approaches include oral GIP‐GLP‐1 receptor co‐agonists, and the combination of long‐acting amylin receptor agonists with GLP‐1 receptor agonists. The ongoing development of incretin‐based therapies and the expanding availability of currently available agents are expected to enhance clinical outcomes further and reduce the burden of obesity‐related health complications. This review aims to discuss the mechanisms and efficacy of current and emerging incretin hormone agonists for obesity management.

2022-04-01·Current Opinion in Endocrinology, Diabetes & Obesity3区 · 医学

Long-acting amylin analogues for the management of obesity

3区 · 医学

Review

作者: Bagger, Jonatan I. ; Mathiesen, David S. ; Knop, Filip K.

Purpose of reviewTo summarize recent developments of long-acting amylin analogues for the treatment of obesity and to outline their mode of action.Recent findingsAmylin is a pancreatic hormone acting to control energy homeostasis and body weight. Activity at the calcitonin and amylin receptors in the area postrema seems to – at least partly – be responsible for these effects of amylin. Both preclinical and early-stage clinical studies investigating long-acting amylin receptor analogues demonstrate beneficial effects on body weight in obesity. Cagrilintide, a novel amylin analogue suitable for once-weekly administration, is in phase II clinical development and has shown promising body weight reducing effects alone and in combination with the glucagon-like peptide 1 receptor agonist semaglutide.SummaryLong-acting amylin analogues have emerged as a possible pharmacotherapy against obesity, but more studies are needed to support the utility and long-term effects of this strategy in relevant populations.

2021-12-01·The Lancet1区 · 医学

Long-acting amylin analogue for weight reduction

1区 · 医学

Article

作者: Gadde, Kishore M ; Allison, David B

项与 GUB-014295 相关的新闻（医药）

2024-11-17

·药明康德

12个月患者总生存率超90%的抗癌联合疗法；治疗慢性HBV感染的表观遗传沉默剂进入临床…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. Cue Biopharma公司公布了其两款新型生物制品的积极临床数据，其中接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性复发性/转移性头颈部鳞状细胞癌（R/M HNSCC）患者12个月时的总生存率为91.3%。 2. 胸苷酸合成酶抑制剂NUC-3373联用pembrolizumab在一项临床研究中使1名尿路上皮膀胱癌患者的靶病灶缩小了100%。 3. 用于治疗慢性乙肝病毒（HBV）感染的表观遗传沉默剂TUNE-401在新西兰获批进入1b期临床试验。药明康德内容团队整理 CUE-101、CUE-102：公布1期临床试验的新数据 Cue Biopharma公司公布其CUE-101治疗头颈癌和CUE-102治疗WT1阳性癌症的1期临床试验的积极新数据。CUE-101是该公司开发的一款基于白细胞介素-2（IL-2）的T细胞诱导剂，旨在选择性调节和激活HPV阳性T细胞，以提高疗效，同时减少传统免疫疗法的副作用。CUE-102是一种由两个呈递WT1肽的人白细胞抗原（HLA）分子、四个亲和力减弱的IL-2分子和一个效应减弱的人免疫球蛋白G（IgG1）Fc结构域组成的新型生物制品，被开发作为单一疗法治疗WT1阳性复发/转移性癌症患者。截至2024年9月11日的数据，接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性R/M HNSCC患者的客观缓解率（ORR）为46%，疾病控制率（DCR）为75%，12个月时的总生存率为91.3%，中位总生存期（OS）为21.8个月。在历史研究KEYNOTE-048中，pembrolizumab单药治疗的ORR为19%，12个月时的总生存率为51%，中位OS为12.3个月。在本研究中，1例患者达到完全缓解（CR），10例患者达到部分缓解（PR），以及7例患者获得了超过12周的持久疾病稳定（SD）。接受该一线联合治疗的PD-L1低表达患者的ORR为50%。截至2024年10月29日的数据，接受CUE-102单药治疗的晚期胰腺癌患者的DCR为67%，其中包括肿瘤负荷减少40%的未确认的PR。有证据表明，WT1特异性CD8阳性T细胞受到了选择性刺激和扩增，而非特异性CD8阳性T细胞的总数没有明显增加。 NUC-3373：公布1b/2期联合治疗临床试验数据 NuCana公司公布了其正在进行的1b/2期模块化研究的初步数据，模块1研究评估了NUC-3373联用PD-1抑制剂pembrolizumab治疗晚期实体瘤患者的疗效，模块2研究评估了NUC-3373联用多西他赛治疗肺癌患者的疗效。NUC-3373是一种胸苷酸合成酶抑制剂，由核苷类似物5-氟尿嘧啶衍生而来，可导致DNA损伤。模块1包括12名患有各种实体瘤、已用尽所有其他治疗方案的患者，其中9例患者曾接受过PD-1/PD-L1抑制剂的治疗。接受NUC-3373联用pembrolizumab治疗后，患者实现了显著的肿瘤体积缩小，PFS得到延长。2名患者获得了确认的PR，4例患者达到SD。在疗效可评估人群中，ORR为22%，DCR为67%。其中，1例尿路上皮膀胱癌患者接受联合治疗后靶病灶缩小了100%（非靶病灶依然存在），1例BRAF突变转移性皮肤黑色素瘤患者的靶病灶缩小了81%。此外，NUC-3373联合pembrolizumab的耐受性普遍良好。模块2包括4名非小细胞肺癌（NSCLC）或胸膜间皮瘤患者，这些患者在既往含化疗方案中出现疾病进展或无法耐受。患者在接受NUC-3373联用多西他赛治疗后PFS得到延长，2例患者实现了长期的SD。 TUNE-401：在新西兰获批启动1b期临床试验 Tune Therapeutics公司宣布，该公司已获得新西兰药品和医疗器械安全局（Medsafe）的临床试验申请（CTA）批准，将推进其用于治疗慢性HBV感染的表观遗传沉默剂TUNE-401进入1b期临床试验。 TUNE-401是一款潜在"first-in-class"的表观遗传沉默剂，利用Tune Therapeutics的多功能、模块化TEMPO平台所开发。TUNE-401通过脂质纳米颗粒（LNP）将编码活性、HBV靶向的RNA直接递送至肝细胞。在这些细胞内，所递送的RNA被翻译为表观沉默蛋白，靶向整合入宿主细胞的乙肝病毒DNA（intDNA）和共价闭合环状DNA（cccDNA）。cccDNA是一种独特、游离的环状染色体（episomes），可作为病毒进行复制时的模板，是造成HBV患者多年持续感染的原因之一。临床医生认为，关闭这些cccDNA“病毒工厂”是实现HBV功能性治愈的必要前提。TUNE-401不涉及切割或编辑DNA，其导致产生的活性表观沉默蛋白通过添加甲基基团与DNA结合，以抑制或失活病毒基因，同时保持人类基因的完整性。根据新闻稿，TUNE-401是首个获批进入临床，用以治疗常见传染病的表观遗传疗法。 KVA12123：公布1/2期临床试验数据 Kineta公司公布了其正在进行的1/2期临床试验的最新进展，该试验评估了其新型在研VISTA阻断免疫疗法KVA12123单药或与PD-1抑制剂pembrolizumab联用在晚期实体瘤患者中的治疗效果。KVA12123是一种单克隆抗体疗法，需每周输注两次。通过将独特的表位与优化的IgG1 Fc区相结合，KVA12123单药在临床前模型中显示出强大的肿瘤生长抑制作用，且在临床试验中没有报告细胞因子释放综合征（CRS）。KVA12123已被证明能降低VISTA靶点的风险，并提供了一种新的方法来解决肿瘤微环境中的免疫抑制问题，其作用机制与以T细胞为重点的疗法不同且互补。截至2024年10月18日的数据，接受KVA12123单药治疗并至少进行了一次随访扫描的19例患者中，有13名实现了SD。在许多接受KVA12123单药治疗的患者中观察到持久的临床结果，其中1名此前已接受过六线治疗（包括免疫检查点抑制剂治疗）的NSCLC患者已保持SD状态60周。在接受KVA12123联合pembrolizumab治疗并至少进行了一次随访扫描的9例患者中，1例粘液表皮样癌患者获得了PR，靶病灶缩小了54%，非靶病灶获得了CR；1名免疫检查点抑制剂治疗后进展的肾细胞癌患者达到SD，靶病灶缩小了24%。安全性方面，KVA12123的耐受性良好，单药或与pembrolizumab联用在任何剂量水平上都未出现剂量限制性毒性（DLT）。 IDRX-42：公布1/1b期临床试验的新数据 IDRx公司公布了其用于治疗晚期胃肠道间质瘤（GIST）的在研口服小分子KIT酪氨酸激酶抑制剂IDRX-42的1/1b期临床试验数据。IDRX-42旨在选择性地靶向最常见的KIT突变形式，这些突变要么驱动肿瘤细胞的初始生长、增殖和生存，要么使肿瘤对现有疗法产生耐药性。截至2024年9月30日的数据，87例中位治疗线数为四线、疗效可评估患者的ORR为29%，包括1例CR和24例PR。接受IDRX-42作为二线治疗患者的ORR为53%（8/15），包括1例CR和7例PR，这些患者的中位PFS尚未达到。接受IDRX-42作为三线治疗的患者的中位PFS估计为12.9个月。既往未使用过ripretinib、接受IDRX-42作为≥四线治疗的患者在推荐的1b期剂量下，其中位PFS估计为11.0个月。此外，IDRX-42具有良好的安全性，在推荐的1b期剂量下，8%的患者减少了剂量，没有因治疗伴发不良事件而停药的情况。 APV-527：公布1期临床试验数据 Alligator Bioscience公司和Aptevo Therapeutics公司公布了APV-527用于治疗可能表达肿瘤抗原5T4实体瘤患者的1期临床试验数据。APV-527是一种靶向4-1BB和肿瘤抗原5T4的双特异性抗体，仅在与4-1BB和5T4同时结合时才有活性。此次公布的结果显示，16例疗效可评估的患者中有9例（56%）达到SD，其中，1例结肠癌患者已保持SD超过6个月。最长的SD持续时间发生在一名乳腺癌患者中，该患者进入研究时病情发生进展，目前病情保持稳定，且已参与研究超过11个月。安全性方面，APV-527在所有队列中均表现出积极的安全性和耐受性，尚未观察到严重的肝毒性。肝毒性是其他4-1BB靶向治疗的常见副作用，可导致患者停药。 ELI-002：公布1期临床试验的初步数据 Elicio Therapeutics公司公布了其在研治疗性癌症免疫疗法ELI-002用于治疗接受标准局部治疗后仍有疾病复发风险的KRAS突变驱动实体瘤的1期临床试验的初步结果。ELI-002由AMP修饰的KRAS突变体（mKRAS）肽段，和一种AMP修饰的免疫刺激寡核苷酸佐剂ELI-004组成，经皮下给药靶向淋巴结。它能产生RAS特异性杀伤性T细胞，以攻击术后残留肿瘤细胞，有望延长癌症患者缓解并可预防未来复发。初步数据表明，靶向KRAS突变体的T细胞反应持久且呈剂量依赖性，并诱导了针对患者特异性新抗原的反应。观察到无病生存期（DFS）与T细胞反应强度之间存在相关性。此外，ELI-002的1期安全性及耐受性特征依然良好，未观察到DLT或CRS。 GUBamy：公布1期临床试验数据 Gubra公司公布了长效胰淀素（amylin）类似物GUBamy在单剂量递增（SAD）1期临床试验中获得的积极结果。GUBamy耐受性良好，表现出良好的药代动力学特征，半衰期为11天，支持每周一次的给药方案。此外，单剂量的GUBamy剂量依赖性地降低体重，这一效果在试验期间（6周）内持续存在。在所有高剂量组（3.5-6.0 mg）中，受试者在6周试验期内的平均体重下降约3％，而安慰剂组的体重平均增长约1％。 ▲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参考资料（可上下滑动查看） [1] Tune Therapeutics Moves into Clinical Spotlight with TUNE-401: A First-in-Class Epigenetic Silencer for Hepatitis B. 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Retrieved November 15, 2024, from https://ir.muraloncology.com/news-releases/news-release-details/mural-oncology-presents-clinical-and-preclinical-data-across-its [13] Tectonic Therapeutic Announces Positive Phase 1a Results in AHA 2024 Presentation for TX45, a Long-acting, Fc-Relaxin Fusion Protein. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978120/0/en/Tectonic-Therapeutic-Announces-Positive-Phase-1a-Results-in-AHA-2024-Presentation-for-TX45-a-Long-acting-Fc-Relaxin-Fusion-Protein.html [14] CG Oncology Announces Nature Medicine Publication of Phase 1b Study Results Evaluating Cretostimogene Grenadenorepvec in Combination with Nivolumab in Muscle-Invasive Bladder Cancer. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978266/0/en/CG-Oncology-Announces-Nature-Medicine-Publication-of-Phase-1b-Study-Results-Evaluating-Cretostimogene-Grenadenorepvec-in-Combination-with-Nivolumab-in-Muscle-Invasive-Bladder-Cance.html [15] Next Generation Gene Therapeutics (NGGT) Announces Positive New Data on NGGT002 for the Treatment of Phenylketonuria (PKU). Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/next-generation-gene-therapeutics-nggt-announces-positive-new-data-on-nggt002-for-the-treatment-of-phenylketonuria-pku-302300911.html [16] Fate Therapeutics Highlights Cancer-selective, HER2-Targeting Profile of FT825 / ONO-8250 CAR T-cell Product Candidate for Treatment of Advanced Solid Tumors at 2024 SITC Annual Meeting. Retrieved November 15, 2024, from https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-highlights-cancer-selective-her2-targeting [17] Neurogene Reports Positive Interim Efficacy Data from First Four Low-Dose Pediatric Participants in NGN-401 Gene Therapy Clinical Trial for Rett Syndrome. Retrieved November 15, 2024, from https://ir.neurogene.com/news-releases/news-release-details/neurogene-reports-positive-interim-efficacy-data-first-four-low [18] IND for ATA-200, a Gene Therapy for the Treatment of Limb-Girdle Muscular Dystrophy Type 2C/R5 (LGMD2C/R5), cleared to proceed by FDA. Retrieved November 15, 2024, from https://www.businesswire.com/news/home/20241112690214/en/IND-for-ATA-200-a-Gene-Therapy-for-the-Treatment-of-Limb-Girdle-Muscular-Dystrophy-Type-2CR5-LGMD2CR5-cleared-to-proceed-by-FDA [19] Nammi Therapeutics, Inc. Announces First Patient Dosed with QXL138AM in a Phase 1 Study Evaluating Advanced Solid Tumors and Multiple Myeloma. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/nammi-therapeutics-inc-announces-first-patient-dosed-with-qxl138am-in-a-phase-1-study-evaluating-advanced-solid-tumors-and-multiple-myeloma-302299498.html [20] Palleon Pharmaceuticals Presents Results from the Phase 1/2 GLIMMER-01 Trial of E-602 in Combination with Cemiplimab in Patients with Solid Tumors at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 15, 2024, from https://www.businesswire.com/news/home/20241108273263/en/Palleon-Pharmaceuticals-Presents-Results-from-the-Phase-12-GLIMMER-01-Trial-of-E-602-in-Combination-with-Cemiplimab-in-Patients-with-Solid-Tumors-at-the-Society-for-Immunotherapy-of-Cancer-SITC-Annual-Meeting/ [21] Cerevance’s CVN293 Demonstrated Positive Phase 1 Results in Healthy Volunteers. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/11/2978299/0/en/Cerevance-s-CVN293-Demonstrated-Positive-Phase-1-Results-in-Healthy-Volunteers.html [22] Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-4015089. Retrieved November 15, 2024, from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-initiation-phase-1-clinical-study-ck-2#:~:text=SOUTH%20SAN%20FRANCISCO%2C%20Calif.%2C%20Nov.%2011%2C%202024%20%28GLOBE,study%20of%20CK-4015089%20%28CK-089%29%20in%20healthy%20human%20participants. [23] EnteroBiotix Announces Positive Ph1b Clinical Results of EBX-102 in Liver Cirrhosis. Retrieved November 15, 2024, from https://www.enterobiotix.com/news/enterobiotix-positive-clinical-results-ebx-102-liver-cirrhosis [24] GenVivo to Present Phase 1 Trial Results for GEN2, A Personalizing Gene Vector Therapy, at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Retrieved November 15, 2024, from https://genvivoinc.com/2024/11/08/genvivo-to-present-phase-1-trial-results-for-gen2-a-personalizing-gene-vector-therapy-at-the-2024-society-for-immunotherapy-of-cancer-sitc-annual-meeting/ [25] Sparian Biosciences Announces Results from the Phase 1 Clinical Trial of First in Class Novel Arylepoxamide Receptor (AEAr) Agonist Analgesic SBS-1000. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/12/2979419/0/en/Sparian-Biosciences-Announces-Results-from-the-Phase-1-Clinical-Trial-of-First-in-Class-Novel-Arylepoxamide-Receptor-AEAr-Agonist-Analgesic-SBS-1000.html [26] Spyre Therapeutics Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for SPY001, Its Novel Half-Life Extended anti-α4β7 Antibody for the Treatment of Inflammatory Bowel Disease, with a Half-Life of >90 Days Supporting the Potential for Both Q3M & Q6M Maintenance Dosing. Retrieved November 15, 2024, from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-positive-interim-results-from-phase-1-healthy-volunteer-trial-for-spy001-its-novel-half-life-extended-anti-47-antibody-for-the-treatment-of-inflammatory-bowel-disease-with-a-half-life-of-90-days-s-302302014.html [27] Nuvectis Pharma Reports Encouraging NXP800 Interim Data Supporting Ongoing Enrollment in Phase 1b Study in Patients with Platinum-Resistant ARID1a-Mutated Ovarian Cancer. Retrieved November 15, 2024, from https://www.globenewswire.com/news-release/2024/11/14/2981017/0/en/Nuvectis-Pharma-Reports-Encouraging-NXP800-Interim-Data-Supporting-Ongoing-Enrollment-in-Phase-1b-Study-in-Patients-with-Platinum-Resistant-ARID1a-Mutated-Ovarian-Cancer.html [28] Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis. Retrieved November 15, 2024, from https://enlivex.com/investors/news-releases/enlivex-announces-the-dosing-of-the-first-patient-in-a-phase-i-clinical-trial-evaluating-allocetra-in-patients-with-psoriatic-arthritis/#:~:text=Nes-Ziona%2C%20Israel%2C%20Nov.%2014%2C%202024%20%E2%80%94%20Enlivex%20Therapeutics,an%20affected%20joint%20in%20patients%20with%20psoriatic%20arthritis. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期临床结果免疫疗法临床1期

2024-11-13

·EndPoints

Danish biotech Gubra touts early weight loss data in hot amylin field

The amylin field is heating up ahead of Novo Nordisk’s much-anticipated CagriSema readout later this year. On Wednesday, Gubra said people taking high doses of its amylin analog, called GUBamy, had a mean loss of 3% of their body weight in a six-week single ascending dose trial. The placebo group, meanwhile, experienced a mean gain of about 1% body weight, the Danish biotech said. Men who were “healthy lean and overweight” were included in the trial. Nausea and reduced appetite were frequent, and vomiting was “occasional” in the trial, Gubra said. Gastrointestinal side effects have been commonly reported with anti-obesity medicines. The news comes the same day obesity biotech Metsera raised $215 million and said it had started testing its own amylin analog in an early-stage clinical study. “I’m excited about these data. It’s confirming what we hoped for that GUBamy is well-tolerated and we were able to dose to quite high levels, and we saw some dose dependency in adverse events,” which is “exactly what you would expect from an amylin,” Gubra CEO Henrik Blou said in an interview with Endpoints News . Gubra’s shares were up about 2%. The company said it plans to share interim results from a multiple ascending dose study in the first half of next year. The biotech believes GUBamy, or GUB014295, can be dosed weekly given its 11 day half-life. Blou declined to disclose Gubra’s expectations for weight loss in the MAD Phase 1b trial. Zealand Pharma’s amylin analog petrelintide led to a mean 8.6% weight loss in a MAD study in June , and the company quickly raised $1 billion off that data. Asked if Gubra also plans to raise money or do a follow-on offering on the back of these data, Blou said Gubra has “no current plans” since the company is “currently well-financed.” Gubra can take GUBamy into Phase 2a, the CEO said, but the company is also exploring partnerships. It counts Boehringer Ingelheim as a partner on other obesity programs. There are likely multiple parties circling the company as amylin has come to the fore as a next-generation approach in the obesity drug landscape. Amylin and other approaches follow the first-generation GLP-1 medicines, which have opened up what is expected to be the biggest pharmaceutical market in history. Novo’s CagriSema, which combines an amylin analog with Wegovy, is slated to have a Phase 3 readout before 2025. Zealand, meanwhile, boasted at the ObesityWeek conference that it believes amylin could potentially replace GLP-1s for some patients. Eli Lilly, AstraZeneca, Structure Therapeutics and others are also in the race. GUBamy is one of multiple shots on goal for Gubra’s obesity pipeline. Its partner Boehringer started testing a triple agonist, of unknown mechanisms, in a Phase 1 this summer. However, Boehringer ended work on a different Gubra obesity drug last month. The duo is also working on other discovery-stage programs, and Gubra is working on its own with other targets, like UCN2 and GLP-1. Blou said Gubra is “still gathering information” on the culled Boehringer drug, a neuropeptide Y receptor type 2 (NPY2) agonist known as BI 1820237. Once it gets the “full picture,” they’ll have a better idea of the drug’s future, he added.

临床1期临床结果临床2期临床3期

2024-11-13

·Firstwordpharma

Danish biotech Gubra touts early win for long-acting amylin in obesity

Two weeks after Boehringer Ingelheim pulled the plug on a partnered obesity programme, Gubra is reporting "positive" Phase I data for its long-acting amylin analogue GUBamy (GUB014295), indicating that the Danish biotech's independent assets may offer promising alternatives.In the single ascending dose study, subjects receiving the highest doses (3.5-6.0 mg) achieved approximately 3% weight reduction over six weeks, while the placebo group gained about 1%. The study was conducted in healthy lean and overweight male subjects with a mean body mass index (BMI) of about 26.7 who were randomised into six cohorts treated with either GUBamy or placebo."We are very pleased to see that our data confirms the potential of GUBamy as an anti-obesity treatment," said CEO Henrik Blou. "GUBamy was well tolerated, and the very long half-life supports a weekly dosing regimen."Gubra said the treatment's pharmacokinetic profile revealed a half-life of 270 hours, or 11 days, supporting weekly subcutaneous administration. Adverse events aligned with expectations for the drug class, primarily presenting as gastrointestinal effects including frequent nausea and reduced appetite, with occasional vomiting.Investors are paying close attention to trial outcomes of amylin-based drugs, which could soon represent a new category in weight-loss therapies. Before the end of the year, Novo Nordisk plans to release data from a large study of CagriSema, a combination of the dual amylin and calcitonin receptor agonist cagrilintide, plus GLP-1 agonist semaglutide, the active ingredient in its popular obesity drug Wegovy. The drugmaker recently reiterated its expectation that the new injection will deliver 25% weight loss.Meanwhile, Zealand Pharma has its own amylin compound, petrelintide, and is actively seeking partners to advance the treatment to the next development phases.

临床结果临床1期

100 项与 GUB-014295 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
肥胖	临床1期	英国	Gubra A/S	2023-11-29

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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


NCT06144684 (Company_Website) 人工标引	临床1期	超重	-	GUBamy	(鏇獵積糧糧憲憲願憲獵) = GUBamy was well tolerated, with the vast majority of events being mild and transient. The most frequent adverse events were gastrointestinal and dose-dependent: Nausea (frequent), reduced appetite (frequent) and vomiting (occasional). 範醖淵壓膚衊選糧網範 (願襯壓網顧廠醖鏇鏇憲 )	积极	2024-11-13
				Placebo