The Attractive 2 Trial - An Open-label, Randomised, 2-period Cross-over Trial to Assess the Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers

This is a single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised.

开始日期2024-04-24

申办/合作机构

Atrogi AB

NCT05409924

/ Completed临床1期

The ATTRACTIVE 1 Trial - a First-in-human Phase I, Dose Escalating, Double-blind, Placebo-controlled, Single and Multiple Dose Trial of ATR-258 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.

开始日期2022-04-11

申办/合作机构

Atrogi AB

[+1]

100 项与 ATR-258 相关的临床结果

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100 项与 ATR-258 相关的转化医学

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100 项与 ATR-258 相关的专利（医药）

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项与 ATR-258 相关的新闻（医药）

2024-05-24

·BioSpace

Atrogi Announces Publication on Advancements in Combatting Obesity and Metabolic Complications

Preclinical data shows precision modulation of beta-2 and beta-3 signaling boosts metabolism and enhances body recomposition STOCKHOLM, Sweden, May 24, 2024 (GLOBE NEWSWIRE) -- Atrogi, a pioneering clinical-stage biotech company advancing treatments for metabolic disorders, announces a publication in the Journal of Molecular Metabolism (1). The research paper validates the mechanism of action of the company’s first-in-class, small molecule, ATR-127, in combating obesity and metabolic complications. Unlike existing anti-obesity therapies that compromise lean muscle mass, ATR-127 induces significant weight loss while preserving crucial lean body mass. ATR-127 binds to both the beta-2 and beta-3 adrenergic receptors in a unique manner, allowing for precise modulation of downstream signaling cascades. Unlike conventional approaches, ATR-127's innovative binding mechanism enables selective activation of specific signaling pathways. This unlocks the full therapeutic potential of beta-2 and beta-3 receptor agonism, maximizing beneficial effects on metabolism and body composition while mitigating the cardiovascular side effects commonly associated with indiscriminate receptor activation. Atrogi’s CEO, Alexandra Ekman Ryding, said, “This publication highlights strong pre-clinical data relating to ATR-127 and validates our approach for the development of a novel modality for the treatment of obesity. We are now advancing our next generation small molecules for the treatment of obesity to IND preparatory studies in H1 next year and expect to enter the clinic in 2026.” Atrogi´s founder and CSO, Tore Bengtsson, a Professor of Physiology at Stockholm University, said, “There is a high demand for novel treatments of obesity without the current debilitating side effects and muscle loss. We believe our pioneering dual receptor beta-agonist approach has the potential to transform the obesity treatment landscape. Our vision is for a more holistic treatment for diabesity and steatohepatitis that not only treats the underlying cause of disease but also supports overall health and quality of life.” The study found that ATR-127 enhances energy expenditure and promotes beneficial metabolic changes by inducing skeletal muscle glucose uptake and the concomitant activation of brown and beige adipose tissue. This results in healthy weight loss - decreasing fat mass but preserving muscle, whilst reducing hepatic inflammation and lipid content. ATR-127’s ability to deliver precise signaling modulation prevents excessive cAMP production thereby lowering cardiac force production and mitigating risks of cardiovascular side effects. This study was a collaborative international effort involving Atrogi AB, and institutions in Europe and Australia, including Stockholm University, Monash University, University of Nottingham, Karolinska Institute, Maastricht University Medical Center, Latvian Institute of Organic Synthesis, Excellerate Bioscience, Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Tübingen University, University of Copenhagen, University of Queensland, and Queensland University of Technology. Atrogi’s unique platform enables the synthesis of compounds capable of modulating signaling downstream of adrenergic receptors in novel ways. By measuring the specific activation of numerous downstream signaling events, Atrogi has created a proprietary library of compounds that engage discrete signaling pathways, each tailored to enhance beneficial effects while mitigating potential side effects in different therapeutic areas. Atrogi's iterative approach to drug development allows for the generation of compounds with optimized signaling profiles and improved efficacy. References (1) Paper: “The novel adrenergic agonist ATR-127 targets skeletal muscle and brown adipose tissue to tackle diabesity and steatohepatitis” Notes to Editors About Atrogi AB Atrogi is a clinical-stage biotech company developing first-in-class, insulin-independent treatments for type 2 diabetes (T2D) and related metabolic disorders, including obesity and muscle-wasting disorders. Atrogi’s lead compound, ATR-258 for T2D, completed a Phase 1a/b clinical trial in March 2024, with Phase II trials planned by the end of 2024. Atrogi also has compounds in pre-clinical development for the treatment of obesity and muscle wasting disorders. ATR-258 binds to the beta-2 adrenoreceptor, initiating a process that mediates the transportation of glucose into skeletal muscle, lowering blood glucose levels and positively affecting several organs affected by T2D. The proprietary small-molecule compound activates the receptor in a novel manner, causing selective modulation and a distinct signaling profile. Atrogi’s platform extends beyond the adrenergic receptor system, offering the potential for application to other GPCRs. By leveraging the signaling complexity of GPCRs, Atrogi aims to develop tailored compounds that engage specific pathways relevant to different clinical conditions, paving the way for safer, more effective therapies. The company has raised over EUR 24 m in total since inception from investors, including Flerie Invest, Korea Investment Partners (KIP) and private investors. This includes a SEK 90 million (approx. EUR 7.6 m) rights issue. The company has also been awarded non-dilutive grants of over EUR 1.5 million from international organizations such as Eurostars, as well as grants from SweLife in recognition of the company’s unique discovery of receptor signaling. The company is based in Solna, near Stockholm, Sweden. Follow the company on LinkedIn and visit its website. Media Contacts Atrogi Alexandra Ekman Ryding, CEO alexandra@atrogi.com Scius Communications (for Atrogi) Katja Stout katja@sciuscommunications.com Tel: +44 7789 435990 Daniel Gooch Tel: +44 7747 875479 daniel@sciuscommunications.com

临床2期

2024-03-19

·药明康德

毛发再生疗法7天即可激活休眠毛囊干细胞；疾病控制率达100%的小分子抑制剂… | 一周盘点

▎药明康德内容团队编辑本期看点1. 新型局部外用小分子疗法PP405的早期临床结果表明，该疗法能重新激活休眠的毛囊干细胞，诱发毛发生长，有望治疗各类型脱发。2. 第三代小分子MEK抑制剂IMM-1-104用于治疗晚期携带RAS突变的实体肿瘤患者的早期临床结果亮眼，100%的患者未产生获得性RAS变异，超半数患者观察到靶病灶的消退。3. 口服HSF1信号通路抑制剂NXP800用于治疗铂类耐药、携带ARID1a突变的卵巢癌患者的1b期试验结果积极，疾病控制率达100%。药明康德内容团队整理PP405：公布1期临床试验数据Pelage Pharmaceuticals公司公布了其新型局部外用小分子疗法PP405的转化研究和1期临床研究的积极数据。PP405是一种强效的局部线粒体丙酮酸载体（MPC）抑制剂，可作用于细胞代谢通路以上调乳酸脱氢酶（LDH）。干细胞对LDH尤为敏感，LDH的上调能够激活干细胞并促进毛发生长。此次公布的数据证明该公司的新型局部外用小分子疗法PP405能重新激活休眠的毛囊干细胞，诱发毛发生长。在接受过面部提升去皱手术的皮肤上，单次外用0.006%和0.06%的PP405可在24小时内提高毛囊干细胞的LDH活性。LDH活性与毛发隆起处Ki67信号的显著增加相对应，表明毛囊干细胞有增殖反应。此外，1期研究还在雄激素性脱发患者中证明了机理和靶点作用。仅在0.05% PP405局部治疗7天后，Ki67信号与基线相比就出现了具有统计学意义的升高。研究人员还观察到新生毛基质（毛发生长周期中由休止期向生长期转变的标志）。Pelage公司将于2024年中期启动PP405的多中心2a期临床试验，招募患有雄激素性脱发的男女患者。PP405还可用于其他类型的脱发，包括休止期脱发（由压力引起的脱发）和化疗引起的脱发。IMM-1-104：公布1/2a期临床试验数据Immuneering公司宣布，其高选择性第三代小分子MEK抑制剂IMM-1-104治疗晚期携带RAS突变的实体肿瘤患者的1/2a期试验取得了积极的顶线结果。IMM-1-104是一款靶向MAPK通路中重要激酶MEK的抑制剂，旨在通过每日一次给药对MAPK通路进行抑制。这次所公布的试验共有41位患者入组，其中胰腺癌患者占63.4%、结直肠癌患者占12.2%、肺癌患者占9.76%。试验中有82%的患者在接受过往治疗时未曾达到部分缓解（PR）或完全缓解（CR）。截至2024年2月20日的数据，IMM-1-104在41例受试者中的耐受性良好，且具有差异化的安全性。22名接受循环肿瘤DNA（ctDNA）检测并接受IMM-1-104治疗的可评估患者中，100%未出现新的获得性RAS变异，支持其具有泛RAS活性。在每天320 mg或240 mg剂量组中，53%的患者观察到靶病灶的消退。在二线治疗中，320 mg剂量组的最佳的患者肿瘤病变消退为-35.7%，240 mg剂量组中为-11.4%；320 mg剂量组的最佳RECIST肿瘤最长直径之和（SLD）减少了18.9%，240 mg剂量组中减少了7.1%。候选的推荐2期剂量（RP2D）为每日一次320 mg，该RP2D得到耐受性、ctDNA、药代动力学（PK）和药效（PD）特征和初始抗肿瘤活性等积极结果的支持。NXP800：公布1b期临床试验的初步数据Nuvectis Pharma公司公布了其开发的口服HSF1通路小分子抑制剂NXP800用于治疗铂类耐药、携带ARID1a突变的卵巢癌患者的1b期临床试验的积极结果。HSF1是一款应激诱导的转录因子，HSF1信号通路在肿瘤发生中起到重要作用，是多项研究验证的抗癌药物靶点。在针对多种类型的晚期实体肿瘤患者开展的1a期试验中，NXP800的临床概况与临床前实验的预期高度一致，没有报告与药物相关的4级或5级事件。此前，NXP80在铂类耐药、携带ARID1a突变卵巢癌中的开发项目已被美国FDA授予快速通道资格。此次公布的结果显示，3名可评估患者的疾病控制率为100%，缓解率为33%。其中，1名达到未确认的PR患者的淋巴结非靶病灶获得了CR。ATSN-201：公布1/2期临床试验首个队列的数据ATSN-201是Atsena Therapeutics公司利用其新型扩散衣壳AAV.SPR开发的基因疗法，用于治疗X连锁视网膜劈裂症（XLRS）。XLRS是由RS1基因的突变引起的，该基因编码一种名为retinoschisin的蛋白，这是一种主要由光感受器分泌的蛋白质，位于视杆细胞、视锥细胞和双极细胞的外表面。XLRS的特点是视网膜层的异常分裂，这会导致视力受损，且无法通过眼镜矫正，随后会导致进行性的视力丧失。该病目前尚无批准的治疗方法。ATSN-201使用的病毒衣壳能够横向扩散到视网膜下注射点以外的位置，实现对中央视网膜的安全和有效的基因递送（在XLRS患者的视网膜中，分裂腔主要集中在中央视网膜部位）。此前的研究显示，AAV.SPR在临床剂量下能够有效递送载荷至视网膜中央凹上的视锥细胞，无需手术分离，并且不会引起炎症。此次公布的数据显示，ATSN-201在1/2期临床试验首个队列的所有3名患者中耐受性良好，没有报告严重不良事件。数据和安全监测委员会建议继续进行第二组，以测试下一个剂量水平的ATSN-201。RGLS8429：公布1b期临床试验数据Regulus Therapeutics公司公布了其开发的新型下一代寡核苷酸疗法RGLS8429用于治疗常染色体显性多囊肾病（ADPKD）的1b期临床试验的新数据。常染色体显性多囊肾病是由PKD1或PKD2基因突变引起的，也是最常见的人类单基因疾病之一，同时是终末期肾病的主要原因。RGLS8429旨在抑制miR-17并优先靶向肾脏，在临床前研究中已被证明能够明显改善肾脏功能、大小和其他疾病严重程度指标，并具有优越的药理学特征。此前，该公司已公布1期单次递增剂量临床试验的结果，结果显示，RGLS8429具有良好的安全性、耐受性和PK特征。此次公布的是1b期研究中第二个队列的结果，患者对RGLS8429的耐受性良好，未发现令人担忧的安全性问题。基于尿液生物标志物分析结果，在2 mg/kg剂量水平下观察到RGLS8429的生物活性。基于影像学的生物标志物的探索性结果令人鼓舞，在PC1和PC2增加最多的患者中，总肾脏体积减少的幅度最大。PC1和PC2是PKD1和PKD2基因的蛋白质产物，已被证明与疾病严重程度呈负相关。Sabirnetug（ACU193）：公布1期临床试验的新数据Acumen Pharmaceuticals公司公布了其新药sabirnetug用于治疗阿尔茨海默病（AD）的1期临床试验的新数据。Sabirnetug是一种选择性靶向毒性可溶性β淀粉样蛋白寡聚体（AβOs）的选择性人源化单克隆抗体。Sabirnetug能够结合AβOs，由于其独特的结合特性，sabirnetug有可能在产生淀粉样蛋白相关成像异常（ARIA，一种抗体疗法产生的常见主要副作用）风险较低的情况下提供治疗益处，因为sabirnetug可以在不直接靶向淀粉样斑块的情况下阻断AβOs的毒性作用。2023年7月公布的结果显示，该试验的初步结果达到了主要和次要目标，为sabirnetug的临床机制验证提供了证据。在较高剂量组的患者中观察到淀粉样斑块快速、剂量相关的显著减少（p=0.01），每四周给药一次60 mg/kg sabirnetug组患者的淀粉样斑块在第63天减少了25%，每两周给药一次25 mg/kg sabirnetug组患者的淀粉样斑块在第70天减少了20%。这一结果与已批准的Aß单克隆抗体在其临床开发阶段相似时间点的平均淀粉样蛋白斑块减少相当。此次公布的脑脊液生物标志物结果显示，与接受安慰剂治疗的患者相比，接受sabirnetug治疗的早期AD患者大脑中与AD病理学相关的生物标志物得到了改善，神经粒蛋白（neurogranin）水平降低了13.9%，p-tau181水平降低了13.0%，Aβ42/40比率呈上升趋势。在所有剂量中，AβOs的靶点作用与神经粒蛋白以及p-tau181的变化之间均存在显著的相关性，高度支持sabirnetug在早期AD患者大脑中的下游药理作用。该公司计划在2024年上半年启动sabirnetug的2期临床试验。ATR-258 Atrogi：公布1a/b期临床试验数据Atrogi公司宣布，其新型β2肾上腺素受体（β2-AR）激动剂ATR-258治疗2型糖尿病（T2D）患者的1a/b期临床试验达到了所有终点。ATR-258可与β2-AR结合，启动葡萄糖向骨骼肌运输的过程，从而降低血糖水平，并对受T2D影响的多个器官产生积极影响。这种专有的小分子化合物以一种新颖的方式激活受体，导致选择性调节和独特的信号传导特征。这种创新方法使解决2型糖尿病的核心问题成为可能。临床前研究表明，它能有效地将2型糖尿病状态逆转到健康水平。KIO-101：公布1期临床试验数据KIO-101是Kiora Pharmaceuticals公司的一种靶向二氢乳清酸脱氢酶（DHODH）的下一代非甾体类免疫调节小分子抑制剂，旨在克服市售的DHODH抑制剂的相关脱靶副作用和安全问题。此次公布的结果显示，使用12天KIO-101滴眼液在24名健康受试者中的安全性和耐受性良好，没有观察到严重的不良事件。与安慰剂组相比，治疗组的结膜充血明显减少。结膜充血是眼部炎症的体征，由多种非感染性和感染性原因引起。大家都在看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▲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] Pelage Presents Late-Breaking Data at AAD 2024 Meeting Demonstrating PP405 Activates Human Hair Follicle Stem Cells Ex Vivo and in Phase 1 Clinical Study. Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/pelage-presents-late-breaking-data-at-aad-2024-meeting-demonstrating-pp405-activates-human-hair-follicle-stem-cells-ex-vivo-and-in-phase-1-clinical-study-302084610.html[2] Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-DM1 for Treatment of Type 1 Myotonic Dystrophy. Retrieved March 11, 2024, from https://www.businesswire.com/news/home/20240308355853/en/[3] Acumen Pharmaceuticals Presents Sabirnetug (sabirnetug) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting. Retrieved March 11, 2024, from https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-presents-sabirnetug-acu193-fluid[4] Kiora Announces Publication of Phase 1 Study Demonstrating Safety, Tolerability and Anti-Inflammatory Activity of KIO-101 in the Treatment of Inflammation of the Eye. Retrieved March 11, 2024, from https://ir.kiorapharma.com/news-events/press-releases/detail/207/kiora-announces-publication-of-phase-1-study-demonstrating[5] ImmunAbs Announces Conclusion of Phase 1 Clinical Trial, Revealing Positive Topline Results. Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/immunabs-announces-conclusion-of-phase-1-clinical-trial-revealing-positive-topline-results-302084998.html[6] Allyx Therapeutics Announces Positive Phase 1b Multiple Ascending Dose Data and Advances ALX-001 to Patients. Retrieved March 11, 2024, from https://www.globenewswire.com/news-release/2024/03/11/2843754/0/en/Allyx-Therapeutics-Announces-Positive-Phase-1b-Multiple-Ascending-Dose-Data-and-Advances-ALX-001-to-Patients.html[7] Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers. Retrieved March 11, 2024, from https://www.globenewswire.com/news-release/2024/03/11/2843764/0/en/Aprea-Therapeutics-Announces-FDA-Clearance-of-IND-for-APR-1051-its-Next-Generation-WEE1-Kinase-Inhibitor-for-Cyclin-E-Overexpressing-Cancers.html[8] Sonnet BioTherapeutics Announces Early Safety Data from the Company’s Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Met the Study’s Initial Pre-Specified Objective. Retrieved March 11, 2024, from https://www.sonnetbio.com/news-media/press-releases/detail/84/sonnet-biotherapeutics-announces-early-safety-data-from-the[9] Sonnet BioTherapeutics Announces Early Safety Data from the Company’s Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Met the Study’s Initial Pre-Specified Objective. Retrieved March 11, 2024, from https://www.sonnetbio.com/news-media/press-releases/detail/84/sonnet-biotherapeutics-announces-early-safety-data-from-the[10] EILEAN THERAPEUTICS APPROVED TO INITIATE FIRST PATIENT TRIAL WITH BALAMENIB (ZE63-0302), A SELECTIVE BEST-IN-CLASS MENIN INHIBITOR. Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/eilean-therapeutics-approved-to-initiate-first-patient-trial-with-balamenib-ze63-0302-a-selective-best-in-class-menin-inhibitor-302085538.html[11] Synnovation Therapeutics Announces First Patient Dosed in Phase I Trial with SNV1521, a PARP1 Selective Inhibitor for the Treatment of Solid Tumors. Retrieved March 11, 2024, from https://www.businesswire.com/news/home/20240311306666/en/[12] Nurix Therapeutics Announces U.S. FDA Lifts Partial Clinical Hold on NX-2127 Phase 1 TrialNurix cleared to introduce new chirally controlled NX-2127 drug product and resume enrollment of new patients into the study. Retrieved March 11, 2024, from https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-announces-partial-clinical-hold-nx-2127-phase[13] Replay’s cell therapy product company Syena announces first patient dosed in Phase 1/2 study of TCR-NK cell therapy for multiple myeloma. Retrieved March 11, 2024, from https://replay.bio/news/replays-cell-therapy-product-company-syena-announces-first-patient-dosed-in[14] Regulus Therapeutics Announces Positive Topline Data from the Second Cohort of Patients in its Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/regulus-therapeutics-announces-positive-topline-data-from-the-second-cohort-of-patients-in-its-phase-1b-multiple-ascending-dose-mad-clinical-trial-of-rgls8429-for-the-treatment-of-autosomal-dominant-polycystic-kidney-disease-ad-302086081.html[15] Atsena Therapeutics Announces Initiation of Dosing in Second Cohort of Phase I/II Clinical Trial Evaluating ATSN-201 Gene Therapy for the Treatment of X-linked Retinoschisis (XLRS). Retrieved March 14, 2024, from https://www.tmcnet.com/usubmit/2024/03/13/9977428.htm [16] Ocugen, Inc. Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410. Retrieved March 14, 2024, from https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-dosing-completion-subjects-geographic[17] Clearmind Medicine Obtains Clearance for its Psychedelic- Based Alcoholism Clinical Trial. Retrieved March 14, 2024, from https://www.clearmindmedicine.com/news-release/clearmind-medicine-obtains-clearance-for-its-psychedelic--based-alcoholism-clinical-trial[18] Immuneering Announces Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846143/0/en/Immuneering-Announces-Positive-Topline-Results-from-Phase-1-Portion-of-its-Phase-1-2a-Clinical-Trial-of-IMM-1-104-in-RAS-Mutant-Solid-Tumors.html[19] Nuvectis Pharma Announces Encouraging Preliminary Data from the NXP800 Phase 1b Clinical Trial in Platinum-Resistant ARID1a-Mutated Ovarian Cancer. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846324/0/en/Nuvectis-Pharma-Announces-Encouraging-Preliminary-Data-from-the-NXP800-Phase-1b-Clinical-Trial-in-Platinum-Resistant-ARID1a-Mutated-Ovarian-Cancer.html[20] Atrogi Announces Positive Clinical Data from First-in-Class Insulin-Independent Treatment for Type 2 Diabetes. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846027/0/en/Atrogi-Announces-Positive-Clinical-Data-from-First-in-Class-Insulin-Independent-Treatment-for-Type-2-Diabetes.html[21] Atrogi Announces Positive Clinical Data from First-in-Class Insulin-Independent Treatment for Type 2 Diabetes. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846027/0/en/Atrogi-Announces-Positive-Clinical-Data-from-First-in-Class-Insulin-Independent-Treatment-for-Type-2-Diabetes.html[22] Nuvation Bio Doses First Patient in Phase 1/2 Study of NUV-1511 for the Treatment of Advanced Solid Tumors. Retrieved March 14, 2024, from https://www.businesswire.com/news/home/20240314331030/en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期临床结果临床1期

2024-03-14

·BioSpace

Atrogi Announces Positive Clinical Data from First-in-Class Insulin-Independent Treatment for Type 2 Diabetes

All endpoints met for novel β₂-adrenoceptor agonist ATR-258 treating root cause of T2D SOLNA, Sweden, March 14, 2024 (GLOBE NEWSWIRE) -- Atrogi, a pioneering clinical-stage biotech company advancing treatments for metabolic disorders, announces the full set of results from its Phase 1 a/b trial with ATR-258, its first-in-class treatment for type 2 diabetes (T2D). This clinical trial, conducted on both healthy volunteers and individuals with T2D, underscores the safety of ATR-258 as a novel β2-adrenoceptor agonist, offering a revolutionary approach to type 2 diabetes treatment. The unique mechanism of action of ATR-258 enables the selective modulation of specific positive intracellular signaling pathways. This innovative approach makes it possible to address the core issue of type 2 diabetes, effectively reversing it to healthy levels as demonstrated in preclinical studies. Atrogi’s CEO, Alexandra Ekman Ryding, said, “This full phase 1a/b data readout is exactly what we were aiming for, with primary and secondary safety endpoints met. This puts us in a strong position to progress our ground-breaking small molecule compound ATR-258 into a larger multi-centre Phase II trial later this year, underpinned with an upcoming Series B financing. We strongly believe that our novel approach could become a transformative treatment for T2D patients.” Atrogi´s founder and CSO, Professor Tore Bengtsson, said, “These safety results strongly validate my long-held vision for a more holistic treatment for diabetes that not only treats the underlying cause but also supports overall health and quality of life. It underscores the therapeutic value of this novel pathway for the treatment of type 2 diabetes. Notably, in the final cohort of people with T2D we had been specifically looking for cardiovascular safety, which is now confirmed.” Atrogi’s board chair, Anders Ekblom, said, “Diabetes and obesity are major global health challenges. Better treatments are needed that improve glycaemic control while maintaining muscle mass, the latter decreasing more prominently in aging and diabetic populations. Atrogi’s unique discovery of receptor signalling, which treats the root cause of the disease via an insulin independent pathway, has the potential to create unique treatment opportunities and even disrupt the current diabetes market.” The ‘ATTRACTIVE 1’ trial1, conducted in Mannheim, Germany, by Clinical Research Services (CRS), was a double-blind, placebo-controlled, randomized trial evaluating the safety of ATR-258 for the treatment of T2D. The complete trial investigated the use of single, and multiple, ascending doses of ATR-258 in 46 healthy volunteers as well as its administration at a fixed dose in 23 T2D patients over 28 days. The final data demonstrated that ATR-258 was safe and well tolerated in healthy volunteers, and, importantly, also in the T2D patients. References 1. ClinicalTrials.gov identifier: NCT05409924 Notes to Editors About Atrogi Atrogi is a clinical-stage biotech company, developing first-in-class, insulin-independent treatments for type 2 diabetes and related metabolic disorders, including obesity and muscle-wasting disorders. Atrogi’s lead compound, ATR-258 for type 2 diabetes, completed a Phase 1a/b clinical trial in March 2024, with Phase II trials planned by the end of 2024. Atrogi also has a compounds in pre-clinical development for the treatment of obesity and muscle-wasting disorders. ATR-258 binds to the β2-adrenoceptor, initiating a process that mediates the transportation of glucose into skeletal muscle, lowering blood glucose levels and positively affecting several organs affected by T2D. The proprietary small-molecule compound activates the receptor in a novel manner, causing selective modulation and a distinct signaling profile. The company has raised over EUR 24 m in total since inception from investors, including Flerie Invest, Korea Investment Partners (KIP) and private investors. This includes a SEK 90 million (approx. EUR 7.6 m) rights issue. The company has also been awarded non-dilutive grants of over EUR 1.5 million from international organizations such as Eurostars, as well as grants from SweLife in recognition of the company’s unique discovery of receptor signaling. The company is based in Solna, near Stockholm, Sweden. Follow the company on LinkedIn and visit its website. Media Contacts Atrogi Alexandra Ekman Ryding, CEO alexandra@atrogi.com Scius Communications (for Atrogi) katja@sciuscommunications.com Tel: +44 7789 435 990 Daniel Gooch Tel: +44 7747 875 479 daniel@sciuscommunications.com

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100 项与 ATR-258 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	德国	Atrogi AB	2022-04-11
肌肉萎缩	临床前	瑞典	Atrogi AB	2025-03-01

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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


NCT05409924 (ATTRACTIVE 1, GlobeNewswire) 人工标引	临床1期	2型糖尿病	46	ATR-258	(夢憲繭膚憲築醖鏇齋顧) = met 願積遞鏇積夢遞遞範壓 (製餘齋製襯鬱簾夢淵膚 ) 达到	积极	2024-03-14