A Single-center Registry and Embedded Interventional Study of the Effects of COVID-19 With and Without Treatment With AT-001 on Cardiac Structure and Function in Patients Hospitalized for Management of COVID-19 Infection

Cardiometabolic disease may confer increased risk of adverse outcomes in COVID-19 patients by activation of the aldose reductase pathway, a trigger of the inflammatory cascade. The study team hypothesizes that aldose reductase inhibition with AT-001 (caficrestat) might represent a novel therapeutic approach to reduce inflammation and risk of adverse outcomes in diabetic patients with COVID-19.
An open-label pilot study to assess safety, tolerability and efficacy of AT-001 in hospitalized COVID-19 patients with history of diabetes mellitus and heart disease will be conducted. Eligible participants will be treated with AT-001 1500 mg twice daily for up to 14 days. Safety, tolerability, survival and length of hospital stay data were compared with matched controls from a contemporaneous registry of COVID-19 patients.

开始日期2020-04-08

申办/合作机构

NYU Langone Health

NCT04083339

/ Active, not recruiting临床3期

Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

开始日期2019-09-20

申办/合作机构

Applied Therapeutics, Inc.

NCT01731093

/ Completed临床1期

Multiple-ascending Dose Clinical Trial of the Safety and Tolerability of Antioxidant (AT-001) Treatment for Reducing Brain Oxidative Stress

The purpose of this study is to determine the safety, bioavailability, and effectiveness of an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium is a very powerful antioxidant that could prove useful in reducing the harmful effects of oxidative stress in the brain and may help prevent diseases such as Alzheimer's. Our recent work has demonstrated that the specific type of selenium compound greatly influences it's ability to enhance brain health and prevent Alzheimer changes in mouse models of this disease.
This study will enroll 24 participants and will allow us to test the hypotheses that yeast-selenium supplementation is safe in the elderly, and that our specific formulation reduces brain oxidative stress.

开始日期2012-03-01

申办/合作机构

Alltech Life Sciences Inc.

100 项与 Caficrestat 相关的临床结果

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100 项与 Caficrestat 相关的转化医学

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100 项与 Caficrestat 相关的专利（医药）

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项与 Caficrestat 相关的文献（医药）

2024-08-01·Current Atherosclerosis Reports

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2024 American College of Cardiology Conference

Review

作者: Minhas, Abdul Mannan Khan ; Hermel, Melody ; Vaughan, Elizabeth M ; Dalakoti, Mayank ; Gupta, Kartik ; Khoja, Adeel ; Slipczuk, Leandro ; Sheikh, Sana ; Virani, Salim S ; Rawlley, Bharat ; Meloche, Chelsea

PURPOSE OF REVIEW:

To summarize selected late-breaking science on cardiovascular (CV) disease prevention presented at the 2024 Scientific Session of the American College of Cardiology (ACC) conference.

RECENT FINDINGS:

The LIBerate-HR trial showed the efficacy and safety of lerodalcibep, a subcutaneous injection that prevents binding of Pro-Protein Convertase Subtilisin/Kexin (PCSK) 9 to low-density lipoprotein (LDL)-receptors resulting in LDL-cholesterol (LDL-C) lowering in patients at very high risk or high risk of atherosclerotic CV disease (ASCVD). The AEGIS-II randomized patients with type 1 myocardial infarction (MI) with multivessel coronary artery disease and additional CV risk factors and found no benefit in major adverse CV events (MACE) with CSL112, an apolipoprotein A1 infusion shown to increase cholesterol efflux capacity. The Bridge-TIMI 73a trial showed a significant reduction in triglyceride (TG) levels with olezarsen, an antisense mRNA, in patients with moderate hyperTG with elevated CV risk. The BE ACTIVE trial showed significant improvement in step counts in patients given behavioral and financial incentives. The DRIVE study showed a significant increase in the prescription of either sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes mellitus (T2DM) at elevated CV or renal risk with a remote team-based, non-licensed navigator and clinical pharmacist approach. The TACTiC trial showed increased and sustained use of statin therapy by patient-driven use of a web-based portal that calculated the ASCVD risk score and gave prompts. The VICTORIAN-INITIATE trial showed efficacy and safety in early use of inclisiran in patients with ASCVD who did not reach target LDL-C < 70 mg/dL despite maximally tolerated statin therapy. The ARISE-HF trial showed no difference in change of peak oxygen consumption with the use of an oral aldose reductase inhibitor, AT-001, in patients with well-controlled T2DM and diabetic cardiomyopathy with high-risk features compared to placebo. The PREVENT trial showed a significant reduction in target vessel failure at 2 years in patients with non-flow limiting vulnerable plaques with percutaneous coronary intervention and optimal medical therapy (OMT) compared to OMT alone. The late-breaking clinical science presented at the 2024 Scientific Session of the ACC paves the way for an evidence-based alternative to statin therapy and provides data on several common clinical scenarios encountered in daily practice.

2024-07-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Racial Differences in Diabetic Cardiomyopathy

Article

作者: Ezekowitz, Justin A ; Marwick, Thomas H ; Zannad, Faiez ; Perfetti, Riccardo ; Januzzi, James L ; Liu, Yuxi ; Rosenstock, Julio ; Butler, Javed ; Lam, Carolyn S P ; Lopez, Jose ; Del Prato, Stefano ; Urbinati, Alessia ; Tang, W H Wilson ; Ibrahim, Nasrien E

BACKGROUND:

Diabetic cardiomyopathy (DbCM) increases risk of overt heart failure in individuals with diabetes mellitus. Racial and ethnic differences in DbCM remain unexplored.

OBJECTIVES:

The authors sought to identify racial and ethnic differences among individuals with type 2 diabetes mellitus, structural heart disease, and impaired exercise capacity.

METHODS:

The ARISE-HF (Aldolase Reductase Inhibitor for Stabilization of Exercise Capacity in Heart Failure) trial is assessing the efficacy of an aldose reductase inhibitor for exercise capacity preservation in 691 persons with DbCM. Baseline characteristics, echocardiographic parameters, and functional capacity were analyzed and stratified by race and ethnicity.

RESULTS:

The mean age of the study participants was 67.4 years; 50% were women. Black and Hispanic patients had lower use of diabetes mellitus treatments. Black patients had poorer baseline ventricular function and more impaired global longitudinal strain. Overall, health status was preserved, based on Kansas City Cardiomyopathy Questionnaire scores, but reduced exercise capacity was present as evidenced by reduced Physical Activity Scale for the Elderly (PASE) scores. When stratified by race and ethnicity and compared with the entire cohort, Black patients had poorer health status, more reduced physical activity, and a greater impairment in exercise capacity during cardiopulmonary exercise testing, whereas Hispanic patients also displayed compromised cardiopulmonary exercise testing functional capacity. White patients demonstrated higher physical activity and functional capacity.

CONCLUSIONS:

Racial and ethnic differences exist in baseline characteristics of persons affected by DbCM, with Black and Hispanic study participants demonstrating higher risk features. These insights inform the need to address differences in the population with DbCM. (Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy [ARISE-HF]; NCT04083339).

2024-07-01·Journal of the American College of Cardiology

Randomized Trial of a Selective Aldose Reductase Inhibitor in Patients With Diabetic Cardiomyopathy

Article

作者: Perfetti, Riccardo ; Ezekowitz, Justin A ; Lewis, Gregory D ; Zannad, Faiez ; Butler, Javed ; Lam, Carolyn S P ; Ibrahim, Nasrien E ; Solomon, Scott D ; Januzzi, James L ; Del Prato, Stefano ; Tang, W H Wilson ; Rosenstock, Julio ; Marwick, Thomas H

BACKGROUND:

Progression to symptomatic heart failure is a complication of type 2 diabetes; heart failure onset in this setting is commonly preceded by deterioration in exercise capacity.

OBJECTIVES:

This study sought to determine whether AT-001, a highly selective aldose reductase inhibitor, can stabilize exercise capacity among individuals with diabetic cardiomyopathy (DbCM) and reduced peak oxygen uptake (Vo₂).

METHODS:

A total of 691 individuals with DbCM meeting inclusion and exclusion criteria were randomized to receive placebo or ascending doses of AT-001 twice daily. Stratification at inclusion included region of enrollment, cardiopulmonary exercise test results, and use of sodium-glucose cotransporter 2 inhibitors or glucagon-like peptide-1 receptor agonists. The primary endpoint was proportional change in peak Vo₂ from baseline to 15 months. Subgroup analyses included measures of disease severity and stratification variables.

RESULTS:

The mean age was 67.5 ± 7.2 years, and 50.4% of participants were women. By 15 months, peak Vo₂ fell in the placebo-treated patients by -0.31 mL/kg/min (P = 0.005 compared to baseline), whereas in those receiving high-dose AT-001, peak Vo₂ fell by -0.01 mL/kg/min (P = 0.21); the difference in peak Vo₂ between placebo and high-dose AT-001 was 0.30 (P = 0.19). In prespecified subgroup analyses among those not receiving sodium-glucose cotransporter 2 inhibitors or glucagon-like peptide-1 receptor agonists at baseline, the difference between peak Vo₂ in placebo vs high-dose AT-001 at 15 months was 0.62 mL/kg/min (P = 0.04; interaction P = 0.10).

CONCLUSIONS:

Among individuals with DbCM and impaired exercise capacity, treatment with AT-001 for 15 months did not result in significantly better exercise capacity compared with placebo. (Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy [ARISE-HF]; NCT04083339).

项与 Caficrestat 相关的新闻（医药）

2025-01-22

·PRNewswire

Arctic Therapeutics Announces €26.5M Oversubscribed Series A Financing

Funding will accelerate the company's anti-amyloid treatment for rare and common forms of dementia. As well as bringing forward a new class of treatment for inflammatory skin diseases. Sanos Group CEO Jeppe Ragnar Andersen joins the board. REYKJAVIK, Iceland and PHILADELPHIA, Jan. 22, 2025 /PRNewswire/ -- Icelandic drug discovery and development company Arctic Therapeutics (ATx) today announced the successful closing of a €26.5 million oversubscribed Series A financing from a broad syndicate of international investors. The syndicate includes the EIC Fund, Iceland's largest privately-held investment firm Kaldbakur, Investcorp-backed Sanos Group, Swiss-based Cerebrum DAO, The Lurie Family Foundation – established by US billionaire Jeffery Lurie – as well as a consortium led by early investors and co-founders of Icelandic unicorn, Kerecis, and Copenhagen-listed Chemometec. Icelandic institutional investors and family offices also participated in the round. "This funding represents a critical milestone in our journey to address significant unmet medical needs, from familial forms of dementia and Alzheimer's to novel treatments for inflammatory skin diseases. The new investors bring expertise and strategic value to the table, enabling us to accelerate the development of groundbreaking treatments," said Ivar Hakonarson, ATx co-founder and CEO. The proceeds from the Series A financing will be used to advance ATx's two frontrunners, AT-001 and AT-004, further into the clinic. Last year, the European Medicines Agency (EMA) approved a pivotal phase IIb/III clinical trial evaluating AT-001 for the treatment of Hereditary Cystatin C Amyloid Angiopathy (HCCAA), a rare form of familial dementia. The new funding will allow ATx to explore the potential of AT-001, an oral treatment designed to prevent the aggregation of harmful amyloid proteins in the brain, in other forms of familial dementia, and eventually Alzheimer's disease. "Recent advances in understanding the role of amyloid proteins and the critical importance of preventing and dissolving plaque formation in the brain underscore the transformative potential of our approach to significantly slow or even prevent these devastating diseases," Hakonarson added. In addition to the AT-001 clinical trial, ATx is also planning to launch a phase IIa clinical trial for AT-004 in Europe post-financing. The therapeutic goal of this approach is to demonstrate safety and efficacy in acne vulgaris before expanding into other inflammatory skin diseases, including atopic dermatitis, rosacea and psoriasis. Additionally, ATx announced the appointment of Jeppe Ragnar Andersen, CEO of Sanos Group, to its board of directors. "Sanos Group's proven expertise in dermatology and recent acquisition of NeuroScios, a CRO specialized in clinical studies in Alzheimer's, strengthens our alignment with ATx's therapeutic focus even further," Andersen said. "We look forward to supporting the ATx team on achieving its goal of bringing forward innovative treatments for dementia and skin diseases to millions of patients," he added. Last year, ATx was selected to join the prestigious EIC Scaling Club, an exclusive community of Europe's most promising scaleups. The Club aims to accelerate the growth of its members, with a goal of scaling 20% of them into unicorns. This aligns with the EIC Fund's investment mandate to provide funding to European companies, which have the potential to meet the world's most pressing challenges. "Investing in innovative solutions to address the global healthcare challenge of dementia is both a responsibility and an opportunity," said Svetoslava Georgieva, Chair of the EIC Fund Board. "In Europe alone, dementia affects over ten million people – placing immense strain on families, healthcare systems, and economies. By providing an equity investment in Arctic Therapeutics, the EIC Fund is supporting groundbreaking preventive treatments that have the potential to change the trajectory of this crisis, improve quality of life, and alleviate the burden on healthcare infrastructure worldwide," Georgieva added. About Arctic Therapeutics Arctic Therapeutics is an Icelandic drug discovery and development company established in 2015 as a spin-off from the US-based Center for Applied Genomics (CAG), a research center at the Children's Hospital of Philadelphia led by ATx founder Hakon Hakonarson, MD, PhD. ATx leverages the transformative power of applied genomics, steering the course of drug development towards safer, more effective treatments for some of the world's most challenging diseases. The company has operations in Iceland, the US and multiple collaborations across Europe. For more information, please visit: and follow us on LinkedIn. About Sanos Group Sanos Group is a leading specialist provider of clinical study services in the global pharma and biotech industry. The group consists of around 200 employees, mainly in Denmark and the United States, but also in Europe and Hong Kong. Last year, Sanos acquired Austrian NeuroScios, which is a contract research organization (CRO) focusing on Alzheimer's and other diseases of the central nervous system. The acquisition is part of the group's strategic development as a multi-niche CRO, adding a third specialist area to the two current scientific areas of osteoarthritis and dermatology. About EIC Fund The European Innovation Council Fund from the European Commission is an agnostic fund: it invests across all technologies and verticals, and all EU countries and countries associated to Horizon Europe. It provides the investment component of the EIC Accelerator blended finance. The European Investment Bank acts as investment adviser to the EIC Fund. The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialization of disruptive technologies, bridging with and crowding in market players, and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The fund pays particular attention to the empowerment and support of female founders as well as the ambition to reduce the innovation divide among EU countries. For media inquires Gulli Arnason, Chief Strategy Officer [email protected] +354 660 0053 This information was brought to you by Cision . The following files are available for download: SOURCE Arctic Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更并购

2025-01-21

·Endpoints

With support from NFL owner Jeffrey Lurie, Icelandic biotech closes Series A for oral Alzheimer's drug

A father-and-son biotech with ties to Iceland and Philadelphia has put together a €26.5 million Series A to develop oral treatments for Alzheimer’s disease and other neurodegenerative conditions. Founded in 2015, Arctic Therapeutics will attempt to push forward work by Icelandic genomics researcher Hákon Hákonarson. His son, Ívar Hákonarson, runs things as CEO. The duo raised funds from a variety of American and European investors, including the charitable foundation of billionaire Jeffrey Lurie, who owns the NFL’s Philadelphia Eagles franchise. Alzheimer’s has thwarted drug developers for decades, thanks to a string of trial failures for therapies based on the amyloid theory — the idea that the disease can be treated, or even reversed, by removing the buildup of amyloid plaque from the brain. Only recently did the FDA approve two such drugs: Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla both demonstrated modest effects at improving patients’ cognition and function. Most efforts to develop amyloid-targeting Alzheimer’s drugs, including Leqembi and Kisunla, involve administration through intravenous infusions in order to more easily cross the blood-brain barrier. Historically, oral Alzheimer’s treatments are much harder to deliver to the brain than IV therapies. The Hákonarsons say they’ve found a way to solve those issues. Arctic’s lead program, AT-001, is a prodrug of an inexpensive antioxidant called N-acetyl cysteine (NAC). Sometimes used as a supplement, it’s been around for about 60 years. It’s currently used to treat Tylenol toxicity and polycystic ovary syndrome, as well as relieve mucus buildup in the lungs, and more. The elder Hákonarson, who is the director of the genomics center at the University of Pennsylvania’s medical school, told Endpoints News that NAC does not normally cross the blood-brain barrier, but Arctic altered the chemistry to make it both fat-soluble and brain-penetrant. By doing so, Hákonarson said AT-001 can prevent the buildup of amyloid plaque from occurring and break up deposits already in the brain. “Our drug is basically blocking any new aggregation,” Hákonarson said of the amyloid plaques. “The critical thing is obviously to try to get it in early, but once you stop and you block any ongoing aggregation and precipitation, the macrophages in the brain, they just remove it.” Arctic plans to first test its hypothesis in smaller disease populations, and last year it received approval from the EMA to start a Phase 2b/3 trial in a rare, familial form of dementia called hereditary cystatin C amyloid angiopathy (HCCAA). If it works in this indication, the plan is to expand into other forms of dementia and Alzheimer’s, according to Ívar Hákonarson. The HCCAA study is expected to last about a year, and an approval in the EU could come as early as the second half of 2026, he added. Arctic’s plans for US trials and a potential launch are still being finalized, but the company is hoping that an EMA approval could help move things along in the US. The biotech also expects to partner with a larger pharma company to commercialize the drug in the US if it’s approved. “Our goal is to get this treatment to the US as soon as possible,” Ívar Hákonarson said. “That is, of course, the largest market, which we will be targeting.” Arctic has another pipeline program called AT-004 that it will develop with the funding. The treatment is a topical solution being developed for a variety of skin conditions, including psoriasis and atopic dermatitis. The company expects to launch a Phase 2a study in acne vulgaris in Europe, and it completed its pre-IND meeting with the FDA for the program last year. In addition to the Lurie Family Foundation, other investors in the Series A included EIC Fund, Kaldbakur, Sanos Group, Cerebrum DAO, early investors and co-founders of Kerecis and ChemoMetec, and several institutional and family investors from Iceland. Editor’s note: This story was updated to correct the nature of two of the Series A investors. Early investors and co-founders of Kerecis and ChemoMetec — and not the companies — invested in Arctic.

临床2期上市批准

2024-12-23

·佰傲谷BioValley

CEO请辞谢罪？这家公司还能翻盘吗

论一家Biotech能够捅出多大的篓子？提交FDA审查的数据弄虚作假、临床试验执行剂量错误，试图糊弄FDA的Applied公司，在2024年末给业内表演了一个什么叫做草台班子。除了被FDA拒绝、警告信打脸，Applied公司还陷入了一场拟议的集体诉讼当中。在这种动荡的时刻，Applied公司的董事长兼首席执行官Shoshana Shendelman卸任了。在董事长兼首席执行官好像为此负责而离职的举动下，投资者并不买账，Applied公司的股价继续下跌，现在已经跌至1美元以下。所以，到底是发生了什么？使得Applied公司声名狼藉。吹捧太过 Applied Therapeutics是一家专注于开发醛糖还原酶抑制剂（ARI）的生物制药公司，其最核心的管线是govorestat——一款具有中枢神经系统渗透性的ARI，被开发用于治疗多种罕见的神经系统疾病，包括半乳糖血症、山梨醇脱氢酶缺乏症（SORD）和磷酸甘露糖变位酶2-先天性糖基化障碍（PMM2-CDG）。 2024年2月，govorestat治疗半乳糖血症的NDA获得了FDA受理，并获得了优先审评。当时，Applied就吹捧，如果获得批准，govorestat将会是首个治疗半乳糖血症药物。不过因为去年Ⅲ期临床试验的失败，FDA于今年3月将govorestat的上审评期延长了三个月，理由是需进一步审查之前提交数据的补充分析。此外，FDA还曾计划在2024年10月召开专家咨询委员会（adcomm）来针对govorestat的上市批准进行讨论。但在今年9月，FDA又改变了主意，取消召开adcomm。 adcomm的取消，意味着govorestat被批准的概率大大提升。这也使得Applied继续鼓吹道，将为半乳糖血症患者带来第一种潜在的治疗方法。延伸阅读：FDA取消召开Adcomm，公司股价大涨69% 原来全是弄虚作假从9月18日FDA取消adcomm，到11月27日感恩节前夕，这段时间Applied一片欣欣向荣。但是好景不长。11月27日，Applied公司接连收到FDA的CRL和警告信。也向业内展示了一波什么叫做毫无底线。原来，govorestat的临床数据中，有11名患者的临床数据被删除了，且无法以电子格式恢复。此外，FDA还指出Applied没有提供“有关govorestat安全性和有效性评价的任何其他分析和描述”。还有临床执行上的给药剂量错误。FDA在审查期间发现，其中一个临床中心的患者被给予了错误的药物剂量，2021年3月至6月期间，至少有19名患者在3个月接受的实际给药剂量低于试验方案规定剂量（80%），而该公司未能向FDA提供有关“错误剂量的性质和程度”的信息。延伸阅读：数据被删，剂量给错，被拒后还能上市吗？感恩节之后，Applied已经暴跌90%。 12月17日，Applied被一项拟议集体诉讼指控。一名投资人称，Applied公司明知道存在这些审查问题，但是并没有披露它们。Applied公司将问题隐藏起来，同时继续分享govorestat的积极消息，并讨论其潜在的批准和商业化计划，使得投资人认为该药物具有较大的可能性获得批准，使得投资者在药物被拒绝、股价暴跌时蒙受损失。该公司后续会如何？实际上，尽管govorestat在半乳糖血症中爆出了“惊天大雷”，Applied公司并没有打算放弃govorestat，还在努力寻找新的机会。 govorestat在FDA的拒绝＋警告二连之后，Applied公司已经主动撤回向欧洲药品管理局（EMA）提交的govorestat用于治疗半乳糖血症的上市许可申请，以在未来收集更多的数据来获得欧盟的批准。另外，Applied公司还推迟了govorestat用于治疗山梨醇脱氢酶缺乏症（SORD）的时间表。此前，Applied公司预计在2025年第一季度向监管机构提交该适应症的上市申请，不过现在已经推迟至2025年第一季度之后，原因是鉴于govorestat在半乳糖血症的临床应用缺陷，Applied公司正在审查govorestat的山梨醇脱氢酶缺乏症（SORD）项目。事实上，这是因为除了抓住govorestat这根稻草之外，Applied公司已经无路可退了。尽管Applied公司管线中还有两款醛糖还原酶抑制剂AT-001和AT-003，但是都靠不住。AT-001治疗糖尿病心肌病的3期临床没有达到主要终点，随后公司表示以外部合作方式开发AT-001；而AT-003则还在临床前阶段。同时Applied公司的资金压力也不小。根据Applied公司发布的2024年第三季度财报，截至2024年9月30日，公司现金及现金等价物、以及短期投资共计9890万美元。时间来到现在，Applied公司的现金流可能更少了，以及govorestat的暴雷，使得Applied公司声名狼藉，失去了投资者的信任，再想获得额外的资金可能并不是那么容易。只能说，留给Applied公司的时间不多了。未来等待Applied公司的，如果不是govorestat成功上市给公司续命，很可能就是现金花光公司破产......未来就算走上寻找战略代替方案，也可能没人看得上...... 小结深陷泥沼的Applied公司，在近日进行了领导层的调整，Shoshana Shendelman博士卸任董事长兼首席执行官。小编怎么看，都有一股子替罪羊的味道。不过，董事长兼首席执行官的离职，进一步催化了Applied公司股价的下跌，目前已经跌至1美元以下。参考资料： 1.https://www.fiercebiotech.com/biotech/applied-therapeutics-ceo-steps-down-under-pressure-fda-rejection-warning-letter-and-class 2.https://ir.appliedtherapeutics.com/news-releases/news-release-details/applied-therapeutics-appoints-john-h-johnson-executive-chairman 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

引进/卖出优先审批临床3期抗体药物偶联物申请上市

100 项与 Caficrestat 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15121

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病心肌病	临床3期	美国	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	澳大利亚	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	加拿大	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	捷克	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	法国	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	德国	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	中国香港	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	波兰	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	西班牙	Applied Therapeutics, Inc.	2019-09-20
糖尿病心肌病	临床3期	英国	Applied Therapeutics, Inc.	2019-09-20

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临床结果

适应症

分期

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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


NCT04083339 (ARISE-HF, Pubmed \| J Am Coll Cardiol) 人工标引	临床3期	糖尿病心肌病	691	AT-001	簾餘積顧願衊鏇選襯願(繭窪積構淵網繭顧簾遞) = 築顧鹹製淵鏇醖鏇夢淵範糧襯齋構繭製衊淵憲 (積糧艱獵壓餘鹹構願觸 )	不佳	2024-04-03
				Placebo	簾餘積顧願衊鏇選襯願(繭窪積構淵網繭顧簾遞) = 餘網蓋壓顧積襯膚膚獵範糧襯齋構繭製衊淵憲 (積糧艱獵壓餘鹹構願觸 )
NCT04083339 (ARISE-HF, GlobeNewswire) 人工标引	临床3期	糖尿病心肌病	675	AT-001 (1000mg BID)	糧範觸憲蓋窪餘齋構夢(範廠齋衊簾獵構醖衊憲) = 網選獵遞憲網鬱製廠醖憲築鏇夢繭築範簾窪觸 (製鬱遞鹽醖淵糧選構廠 ) 更多	积极	2024-01-04
				AT-001 (1500mg BID)	製願窪夢餘膚範顧壓簾(餘鏇顧選夢齋網夢蓋鬱) = 糧鏇壓夢鬱範醖製積衊鹽網壓願艱顧鑰觸膚積 (餘簾繭醖憲繭繭範鬱遞 ) 更多
NCT04083339 (AT-001, EASD2020)	临床1/2期	糖尿病心肌病	-	AT-001	鏇鑰選築鏇願範網淵餘(鹹餘膚鹹襯築壓鬱艱糧) = 獵鑰餘壓繭網齋醖鑰夢繭遞憲築淵構淵壓餘鹹 (獵觸觸餘築餘淵築鬱構 )	积极	2020-09-23
				Zopolrestat	壓遞餘簾衊鹽願鏇築壓(醖夢簾醖積網觸鏇願積) = 願構糧夢積淵鬱醖築鏇窪壓衊築遞鬱窪範觸築 (鹹艱壓構鹽構製廠獵積 ) 更多