A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis - VALOR-CKD

开始日期2019-03-06

申办/合作机构

Tricida, Inc.

NCT03710291 / Terminated临床3期

A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

开始日期2018-11-20

申办/合作机构

Tricida, Inc.

EUCTR2018-001303-36-BG / Unknown status临床3期

开始日期2018-11-14

申办/合作机构

Tricida, Inc.

100 项与 Veverimer 相关的临床结果

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100 项与 Veverimer 相关的转化医学

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100 项与 Veverimer 相关的专利（医药）

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项与 Veverimer 相关的文献（医药）

2024-03-01·Journal of the American Society of Nephrology : JASN

VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients with Metabolic Acidosis

Article

作者: Perkovic, Vlado ; Wheeler, David C ; Wesson, Donald E ; Bushinsky, David A ; Stasiv, Yuri ; Parsell, Dawn ; Li, Elizabeth ; Tangri, Navdeep ; Mathur, Vandana S ; Inker, Lesley A ; Walker, Michael ; Klaerner, Gerrit

Significance Statement:

Metabolic acidosis is a common complication of CKD and is associated with more rapid decline of kidney function, but well-powered controlled randomized trials testing the effect of treating metabolic acidosis on slowing CKD progression have not been conducted. The VALOR-CKD study randomized 1480 individuals with CKD and metabolic acidosis, across 320 sites to placebo or veverimer (a novel hydrochloric acid binder). The findings did not demonstrate the efficacy of veverimer in slowing CKD progression, but the difference in serum bicarbonate between placebo and drug arms was only approximately 1 mEq/L. Veverimer was safe and well tolerated.

Background:

Metabolic acidosis is common in CKD, but whether its treatment slows CKD progression is unknown. Veverimer, a novel hydrochloric acid binder that removes acid from the gastrointestinal tract, leads to an increase in serum bicarbonate.

Methods:

In a phase 3, double-blind, placebo-controlled trial, patients with CKD (eGFR of 20–40 ml/min per 1.73 m2) and metabolic acidosis (serum bicarbonate of 12–20 mEq/L) from 35 countries were randomized to veverimer or placebo. The primary outcome was the composite end point of CKD progression, defined as the development of ESKD (kidney transplantation or maintenance dialysis), a sustained decline in eGFR of ≥40% from baseline, or death due to kidney failure.

Results:

The mean (±SD) baseline eGFR was 29.2±6.3 ml/min per 1.73 m2, and serum bicarbonate was 17.5±1.4 mEq/L; this increased to 23.4±2.0 mEq/L after the active treatment run-in. After randomized withdrawal, the mean serum bicarbonate was 22.0±3.0 mEq/L and 20.9±3.3 mEq/L in the veverimer and placebo groups at month 3, and this approximately 1 mEq/L difference remained stable for the first 24 months. A primary end point event occurred in 149/741 and 148/739 patients in the veverimer and placebo groups, respectively (hazard ratio, 0.99; 95% confidence interval, 0.8 to 1.2; P = 0.90). Serious and overall adverse event incidence did not differ between the groups.

Conclusions:

Among patients with CKD and metabolic acidosis, treatment with veverimer did not slow CKD progression. The lower than expected bicarbonate separation may have hindered the ability to test the hypothesis.

Clinical Trial registry name and registration number:

VALOR-CKD, NCT03710291.

2023-12-01·Journal of cachexia, sarcopenia and muscle

Effects of correcting metabolic acidosis on muscle mass and functionality in chronic kidney disease: a systematic review and meta‐analysis

Review

作者: Hoorn, Ewout J. ; Visser, Wesley J. ; van der Burgh, Anna C. ; de Roos, Nicole M. ; Severs, David ; van de Braak, Elma E.M. ; van der Hoef, Iris ; de Mik ‐ van Egmond, Anneke M.E. ; Olieman, Joanne F. ; Jans, Inez

Abstract:

Metabolic acidosis unfavourably influences the nutritional status of patients with non‐dialysis dependent chronic kidney disease (CKD) including the loss of muscle mass and functionality, but the benefits of correction are uncertain. We investigated the effects of correcting metabolic acidosis on nutritional status in patients with CKD in a systematic review and meta‐analysis. A search was conducted in MEDLINE and the Cochrane Library from inception to June 2023. Study selection, bias assessment, and data extraction were independently performed by two reviewers. The Cochrane risk of bias tool was used to assess the quality of individual studies. We applied random effects meta‐analysis to obtain pooled standardized mean difference (SMD) and 95% confidence intervals (CIs). We retrieved data from 12 intervention studies including 1995 patients, with a mean age of 63.7 ± 11.7 years, a mean estimated glomerular filtration rate of 29.8 ± 8.8 mL/min per 1.73 m2, and 58% were male. Eleven studies performed an intervention with oral sodium bicarbonate compared with either placebo or with standard care and one study compared veverimer, an oral HCl‐binding polymer, with placebo. The mean change in serum bicarbonate was +3.6 mEq/L in the intervention group and +0.4 mEq/L in the control group. Correcting metabolic acidosis significantly improved muscle mass assessed by mid‐arm muscle circumference (SMD 0.35 [95% CI 0.16 to 0.54], P < 0.001) and functionality assessed with the sit‐to‐stand test (SMD −0.31 [95% CI −0.52 to 0.11], P = 0.003). We found no statistically significant effects on dietary protein intake, handgrip strength, serum albumin and prealbumin concentrations, and blood urea nitrogen. Correcting metabolic acidosis in patients with CKD improves muscle mass and physical function. Correction of metabolic acidosis should be considered as part of the nutritional care for patients with CKD.

2023-05-31·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Design and population of the VALOR-CKD study: a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of veverimer in slowing progression of chronic kidney disease in patients with metabolic acidosis

Article

作者: Wheeler, David C ; Bushinsky, David A ; Perkovic, Vlado ; Parsell, Dawn ; Wesson, Donald E ; Stasiv, Yuri ; Walker, Michael ; Tangri, Navdeep ; Li, Elizabeth ; Inker, Lesley ; Mathur, Vandana S ; Klaerner, Gerrit

ABSTRACT:

Background:

Whether treating metabolic acidosis slows progression of chronic kidney disease (CKD) has not been established. Veverimer is a novel hydrochloric acid binder that removes acid from the gastrointestinal tract leading to an increase in serum bicarbonate; it is being developed to treat metabolic acidosis with the goal of slowing progression of CKD.

Methods:

The VALOR-CKD trial is an international, randomized, multicenter, double-blind, placebo-controlled study designed to evaluate the effect of once-daily veverimer on kidney disease progression in patients with metabolic acidosis and CKD. Eligibility criteria include a serum bicarbonate in the range of 12–20 mmol/L and an estimated glomerular filtration rate (eGFR) of 20–40 mL/min/1.73 m2. The primary outcome is kidney disease progression defined as the development of end-stage kidney disease, a sustained decline in eGFR of >40% from baseline or death due to kidney failure. Key secondary endpoints include effects on physical function.

Results:

Between December 2018 and December 2021, 1480 participants were randomized. The mean age at baseline was 65.1 years and 42% of the patients were female. The mean baseline eGFR was 29.1 mL/min/1.73 m2 and mean serum bicarbonate was 17.5 mmol/L. The median urine albumin-to-creatinine ratio at screening was 201 mg/g and the median 5-year predicted risk of kidney failure was 32%. Diabetes and hypertension were present in 56% and 98% of participants, respectively.

Conclusions:

VALOR-CKD has recruited a large population of people with metabolic acidosis at high risk for CKD progression to determine the effects of veverimer on the risk of progressive loss of kidney function.

项与 Veverimer 相关的新闻（医药）

2024-06-01

·研发客

降糖、减重、代谢药物试验设计新思路 | 第一现场

// 尽管当下全球非肿瘤药物研发已群雄逐鹿，但纪立农教授认为，以心血管-肾脏-代谢疾病三联症为新药研发主导思路，企业现在进入这些领域为时不晚。在第二届中国糖尿病和代谢性疾病药物器械创新研发大会上，北京大学人民医院内分泌科主任纪立农教授认为，如果从心血管-肾脏-代谢三联症（CKM）联合开发入手，将为新药研发提供新启示。“这种跨学科的融合研究有望为治疗代谢性疾病开辟新的道路。”他说。纪立农教授海森生物首席医学官肖申博士告诉研发客，代谢性疾病等三联症药物临床试验的目的在于验证药物在降低血糖、改善血脂、减轻体重等的疗效及安全性。其临床主要终点多为替代终点，包括血压、血脂、肾功能、糖化血红蛋白等临床生化指标，次要终点可能包括生活质量、并发症发生率等。肖申而随着近年来，美国FDA和国家药监局药审中心大力提倡以模型引导的药物研发（MiDD（Model-informed Drug Development），来自北医三院药物临床试验机构副主任刘东阳教授认为，这是一种新药研发模式的重大转变，也越来越多被运用到代谢类药物早期试验设计中。刘东阳教授心血管-肾脏-代谢三联症紧密联系纪立农教授在大会上剖析了心血管-肾脏-代谢三联症之间的紧密联系。心血管疾病涉及心脏和血管异常，如高血压、冠心病；肾脏疾病影响肾脏功能，如慢性肾病；代谢性疾病则与体内代谢紊乱相关，如糖尿病、肥胖。这些疾病之间存在密切关联，如高血压既是心血管疾病的风险，也会影响肾脏健康；糖尿病不仅影响血糖，还可能导致心血管和肾脏问题；肥胖则与心血管、糖尿病和肾脏疾病等多种疾病紧密相关。当前，我国心血管疾病患病人数达3.3亿，慢性肾脏病患病人群1.2亿，糖尿病患病人群1.41亿。纪立农进而通过大量的临床数据/证据阐释了CKM的成因、驱动因素及对其干预的临床证据角度。数据显示，患有心血管疾病的患者，出现慢性肾病的概率较普通人增加2倍；有慢性肾病的患者，出现慢性心血管疾病的风险也增加了20%~40%。同时，患有慢性肾病患者出现血糖代谢紊乱的概率也在明显增高。他指出，CKM是多种病理生理相互作用导致的全身性疾病，不是三组分间简单的因果关系。目前，一线糖尿病治疗药物二甲双胍、吡格列酮及新型降糖药物SGLT-2i、GLP-1RA在改善糖脂代谢、降低肝酶水平、减少肝脏脂肪含量等方面均发挥有益作用，但在改善肝脏组织学变化方面的作用存在差异。纪立农说，因此，当下CKM防治中仍缺少更有效、更持久的减重、控糖和心衰保护的治疗药物和策略，存在大量未被满足的需求。纪立农说，CKM的管理需要针对多重病理生理机制进行综合干预，DPP-4，GLP-1RA，SGLT2i，MRA 等靶点的新型降糖药将有望成为新的标准治疗方案。随着GLP-1RA类药物的上市，患者的血糖控制效果得到改善。在并发症治疗方面，GLP-1RA类药物不仅在减重方面表现较佳，同时还具有降低肾病风险的效果。此外，除了GLP-1RA，纪立农认为，还有多种值得投入的研发方向。如在CKM治疗过程中，SGLT2i被证实具有减轻肥胖及其相关风险，还能有效降低高血脂和肾脏并发症的发生，减少细胞营养过剩的负面影响，改善血液动力学状态。代谢类药物试验设计之特点肖申在成功领导肿瘤药物的临床开发后，已回归到他熟悉且长期致力于的心内科和肾脏药物研发领域。他所在的海森生物专注代谢与心血管产品的研制与销售，其独特的商业模式在于引入国际上处于晚期试验阶段或境外已上市的药物，迅速布局销售市场。在稳固市场地位后，公司再投入研发创新。肖申也参加了中国糖尿病和代谢性疾病药物器械创新研发大会及珠海濠麦科技与研发客举办的代谢类药物研发头脑风暴会议。他赞同纪立农三联症药物开发的观点，并认为，心血管、肾脏和代谢性疾病之间虽然各自独立，在病因、发病机制、临床表现和治疗方面也存在显著的差异，但很多情况下密切关联，且相互影响。在临床终点选择上，肖申说，代谢性疾病药物在临床试验中常常选择替代终点。研发人员应该考虑如何量化这些替代指标，保证判断将来真正有意义的临床获益，而不仅仅是统计上的显著性；如何评估复合终点中的每个成分；如何结合药物的安全性来评估风险获益都是要考虑的。关键性临床试验的设计和实施应当能够解决上述临床问题，并应当遵循FDA对于代谢性疾病药物临床试验的指导原则，即关注患者获益的临床终点评估。他举了Veverimer治疗慢性肾功能不全相关的代谢性酸中毒临床失败的例子。从统计学上分析，该药可以明显改善代谢性酸中毒，但无法确定这种改变的临床价值。FDA评估认为，既然无法确定代谢性酸中毒的改善程度具有的临床价值，那么应当考虑采用其他具有明确临床意义的终点，例如延缓慢性肾脏病（CKD）向终末期肾病（ESRD），即需要透析或移植的阶段的进展，或者降低患者的死亡率等。而最终Veverimer 没有达到这些临床终点，被FDA拒绝批准。“这个例子说明了确定临床终点的重要性，以及如何用替代终点正确预测有临床意义的病人获益，这些工作在试验早期就应该做好全面的评估。”肖申说。此外，FDA专家会于5月24日投票决定不推荐诺和诺德针对1型糖尿病患者每周注射一次胰岛素icodec。专家会以7:4的投票结果认为，icodec对1型糖尿病患者的潜在益处未显著超过其可能带来的风险。针对这一案例，肖申认为，这体现出FDA的担忧在于，与使用诺和诺德另一种长效胰岛素Tresiba的患者相比，使用icodec的3期临床试验中患者低血糖发生率较高。为此，诺和诺德提出了多种预防低血糖事件的解决方案，并强调与FDA合作。“企业在进行新药研发时应注重与现有药物的对比研究，明确新药的临床优势，通过严谨的临床试验和长期监测来验证其疗效和安全性。”肖申说。在三联症药物开发过程中，早期试验非常重要，包括剂量确定、临床疗效评估及生物表记物应用等，需要与CDE进行细致的沟通交流。非肿瘤药物的开发常常是首先在健康受试者测试以保证准确发现任何可能的，由新药导致的安全信号。这类药物早期最注重患者的安全性及是否会发生长期毒性。因此，肖申说，药物在首次进入人体试验前有非常严格的要求，包括清晰的确定NOAEL（未观察到不良反应的剂量）等为主要依据进行推算。研发重点在于调节和平衡机体的代谢过程，因此起始剂量的设定会倾向于保守，以确保患者的安全，并避免可能出现的严重不良反应。而肿瘤药则更倾向于在确保安全的前提下追求最大的治疗效果，有时候对毒性的要求稍微松一些。定量药理加速代谢药物开发在早期试验中，定量药理的运用越来越多。刘东阳分别在成都、珠海及苏州的DIA中国年会上介绍了在糖尿病及代谢药物开发中，定量药理学模型对加速开发和推动精准用药研究的作用。刘东阳作为主要研究者曾负责过20多项IIT，包括50多个1类创新药的早期临床开发或模型引导的临床开发项目，同时针对心血管、肿瘤等探索定量药理学引导的新药加速开发新模式，建立了药动药效学虚拟人数据库，揭示关键参数，建立定量药理学模型预测新算法。他认为，基于药动药效学虚拟人的研究可能是未来颠覆新药开发的新模式，定量药理学是其基础。定量药理学研究的核心问题在于如何增强模型的预测能力，以实现精确预测。这一研究涵盖了剂量-暴露量-效应的定量关系分析，及探究其中的限速变量（如代谢酶）及其显著影响因素的定量规律。早期临床试验阶段最重要的任务就是明确剂量-暴露量-效应典型关系及其内外影响因素，定量药理学在其中发挥着关键作用，从而提高新药开发的成功率。近年来，美国FDA和国家药监局药审中心都大力提倡以MiDD（Model-informed Drug Development）即“模型引导的药物研发”，这是一种新药研发模式的重大转变。MIDD的核心原理是根据血药浓度（即暴露，PK）与疗效/安全性（即效应，PD）的对应数据建立PK-PD模型，再根据研究目的设置模拟条件，分析典型人群和亚组人群的暴露-效应关系，以替代难以获得的剂量-效应关系，从而建立药物有效性和安全性的证据链。国家药监局药审中心近年来出台各项MiDD技术指南MiDD决定了临床试验是否继续，对开发策略的制定、豁免和优化试验都发挥着较大作用。“MIDD助力我国创新药加速上市，能够增强药效，对于代谢性疾病药物增加安全性。”刘东阳说。而通过定量药理学而豁免临床试验的例子，当属盛世泰科自主原研药DPP-4抑制剂森格列汀（曾用名：盛格列汀）。盛世泰科首席执行官余强博士早年从北京大学化学系毕业后，远赴美国深造，拥有30年的小分子药物研发经验。2010年，他回国并创办了专注于代谢类药物、肿瘤药物研发的创新型生物医药公司。他回顾说，2019年7月，森格列汀在DPP-4抑制剂领域开创了首个定量药理学模型。通过这一模型，研究人员精确推算了给药12周、24周后HbA1c（糖化血红蛋白）的变化值，从而科学预测了森格列汀在3期临床试验中的最佳剂量。这使得森格列汀成为首个通过定量药理模型直接跨越2期，进入3期临床的品种。余强仍清晰地记得，当早期临床药理研究的结果揭晓之际，我国著名药理学家，北京协和医院临床药理研究中心的江骥教授深夜给他打来电话，那份由衷的祝贺让他倍感鼓舞。余强据悉，在本次大会还成立了糖尿病和代谢性疾病临床试验协作网。据中国医药创新促进会执行会长宋瑞霖博士介绍，协作网将邀请全国糖尿病及代谢性疾病领域的各方专家，从临床试验管理/执行、数据管理/统计、医学撰写等维度全方位提供助力，搭建临床研究协作平台。“代谢类疾病的临床医学界与工业界应紧密合作，构建和谐生态环境，以期为患者研发出具有临床疗效的药物。这是我们协作网成立的初衷。”他最终总结说。宋瑞霖编辑 | 戴佳凌dai.jialing@PharmaDJ.com 总第2124期访问研发客网站可浏览更多文章www.PharmaDJ.com

临床研究

2024-04-26

·PRNewswire

Renibus Therapeutics Announces Oral Presentations on RBT-1 at AATS and SCA Medical Conferences

SOUTHLAKE, Texas, April 26, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced its participation at two prestigious medical conferences: the American Association for Thoracic Surgery (AATS) 104th Annual Meeting and the Society of Cardiovascular Anesthesiologists (SCA) 46th Annual Meeting, both taking place in Toronto, Canada, April 27-30, 2024. "We are pleased to present additional clinical data on RBT-1 at the AATS and SCA meetings in collaboration with key opinion leaders in our field, Drs. Charles Mack and Andrew Shaw," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "These presentations are critical to advancing the understanding of our preconditioning approach with RBT-1, and we thank the meeting organizers and principal investigators for their partnership. Our Phase 3 PROTECT study is enrolling well and we remain on track to report top-line data in the third quarter of 2025." RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing cardiac surgery.Renibus Therapeutics is actively enrolling its PROTECT Phase 3 pivotal trial evaluating RBT-1's potential to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received both FDA Breakthrough and Fast Track Designations. Details of the oral presentations at AATS: Title: RBT-1 Reduces Incidence of Blood Product Utilization in Patients Undergoing Non-Emergent Coronary Artery Bypass Grafting and/or Valve Surgery Date and Time: Sunday, April 28th at 9:44 am ET Location: Room 714 Presenter: Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine Title: RBT-1 Reduces the Number of Post-Operative Complications Associated with Cardiac Surgery Date and Time: Sunday, April 28th at 4:03 pm ET Location: Theater 2, Exhibit Hall Presenter: Bhupinder Singh, MD, Chief Medical Officer, Renibus Details of the oral presentation at SCA: Title: RBT-1 Improves Clinical Outcomes in Patients Requiring Prolonged Intensive Care Unit Stay Following Non-Emergent Cardiac Surgery Date and Time: Sunday, April 28th at 3:00 pm ET Session: Best of Meeting Oral Presenter: Andrew Shaw, MD, FRCA, FCCM, FFICM, Professor and Chair, Department of Intensive Care and Resuscitation, Cleveland Clinic About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory andantioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

临床3期快速通道临床2期突破性疗法

2024-04-18

·PRNewswire

Renibus Therapeutics Announces Oral Presentation on RBT-1 at the European Association for Cardio-Thoracic Surgery (EACTS) 2nd Innovation Summit

SOUTHLAKE, Texas, April 18, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced an oral presentation on RBT-1 at the prestigious, invitation only, European Association for Cardio-Thoracic Surgery (EACTS) 2nd Innovation Summit, taking place in Paris, France, April 18-20, 2024. Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery and Vice Chairman of Quality and Patient Safety, New York-Presbyterian Hospital, Weill Cornell Medicine, will be presenting on behalf of Renibus. RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing elective cardiac surgery. RBT-1 is actively enrolling in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received FDA Breakthrough and Fast Track Designations. "Presenting at EACTS enables Renibus to share our promising RBT-1 results with the global cardiothoracic surgery community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "In a completed Phase 2 clinical trial, RBT-1 demonstrated the potential to improve outcomes in the post-cardiac surgery setting, including reductions in 30-day hospital readmission rates, time in the ICU, as well as time on ventilator. We continue to advance RBT-1 through the Phase 3 PROTECT study, with top-line data expected in the third quarter of 2025." Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, added, "RBT-1 is an exciting pre-conditioning agent and I am honored to showcase its results at EACTS. While RBT-1 has demonstrated its potential benefit across multiple cardiac surgery types in its Phase 2 clinical trial, I look forward to presenting data demonstrating RBT-1's potential to have a greater impact on patients undergoing more complex procedures combining both CABG and valve surgeries where the risk of post-operative complications is greatest." Details of the oral presentation at EACTS 2nd Innovation Summit: Title: RBT-1: A Pharmacologic Approach to Reducing the Risk of Post-Operative Complications in Patients Workshop Group: Future of Extracorporeal circulation. Hypothermia in CT surgery Date and Time: Friday, April 19, 2024, 15:55 Presenter: Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory and antioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

临床2期临床3期快速通道突破性疗法

100 项与 Veverimer 相关的药物交易

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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
酸中毒	申请上市	美国	Tricida, Inc.	2019-09-04
慢性肾病	临床3期	美国	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	保加利亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	克罗地亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	匈牙利	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	塞尔维亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	斯洛文尼亚	Tricida, Inc.	2017-09-26
慢性肾病	临床3期	乌克兰	Tricida, Inc.	2017-09-26

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临床结果

适应症

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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


NCT03390842 (Pubmed) 人工标引	临床3期	酸中毒 \| 慢性肾病	77	Veverimer	遞膚糧製築觸鹹廠簾壓(衊鏇築簾鑰憲製糧艱網): P-Value = 0.0002 更多	积极	2022-02-25
				Placebo
NCT03390842 (CTgov)	临床3期	慢性肾病	196	TRC101 (TRC101 Treatment Arm)	糧網窪醖鹽簾構糧淵糧(齋壓獵窪鏇膚窪範廠衊) = 壓醖齋艱襯鬱糧觸憲窪艱簾鏇積範襯齋繭積範 (鹽淵選艱衊壓鏇範蓋餘, 繭淵憲遞鬱構夢願鬱簾 ~ 網繭遞糧積顧糧遞窪築) 更多	-	2021-10-22
				Placebo (Placebo Treatment Arm)	糧網窪醖鹽簾構糧淵糧(齋壓獵窪鏇膚窪範廠衊) = 積鏇築構觸蓋鬱範鏇築艱簾鏇積範襯齋繭積範 (鹽淵選艱衊壓鏇範蓋餘, 鏇襯鬱窪繭廠遞廠獵築 ~ 鏇窪鏇遞簾顧糧衊鹹鹹) 更多
NCT03317444 (CTgov)	临床3期	慢性肾病	217	TRC101 (TRC101 Treatment Arm)	範獵顧夢廠廠襯夢簾醖(蓋膚簾鑰選糧蓋糧鬱廠): Treatment difference in % of subjects = 36.7 (95% CI, 23.5 ~ 48.9), P-Value = < 0.0001; Treatment difference in % of subjects = 34.5 (95% CI, 21.2 ~ 46.8), P-Value = < 0.0001; Treatment difference in % of subjects = 33.1 (95% CI, 19.7 ~ 45.6), P-Value = < 0.0001 更多	-	2021-04-26
				Placebo (Placebo Treatment Arm)
ASN2020	临床3期	-	217	Veverimer	鏇遞鏇鹽範襯鏇鹹膚鏇(範淵憲網膚齋襯餘鬱構) = improved both KDQOL-PFD scores and RCS time 鬱築鹹襯衊蓋鏇壓範積 (範蓋艱積餘簾鏇積簾簾 ) 更多	积极	2020-10-19
ASN2020	临床3期	慢性肾病	196	Veverimer	鏇範鬱觸顧襯選獵積糧(淵積膚遞鏇觸獵築廠獵) = significantly improved in the veverimer group (+12.5 v +0.3, P <0.001) 糧鏇壓鑰齋網淵構築選 (獵窪顧糧夢廠蓋鬱網衊 )	积极	2020-10-19
ASN2020	临床3期	-	193	Veverimer	艱鹽觸鬱獵構鏇夢鹹醖(繭鬱鹹淵遞窪獵網鑰餘) = 鬱醖鹽醖艱艱範淵構選範襯艱齋夢艱網網醖鏇 (願壓襯淵餘積製範齋構 )	积极	2020-10-19
Phase 3 randomized, blinded, placebo-controlled trials (ASN2020)	临床3期	慢性肾病	217	Veverimer	糧範遞獵膚簾齋願鏇繭(鹽廠願鏇憲夢積窪顧壓) = 糧獵簾膚糧鬱壓繭鏇選糧構遞餘蓋膚醖鏇衊製 (艱觸淵窪壓夢簾襯觸鏇 )	积极	2020-10-19
ASN2020	N/A	-	-	Veverimer	艱範蓋製壓淵窪製積選(積鏇觸壓襯齋鹽餘選願) = 衊鹽願觸糧淵積獵襯鏇網範餘網觸壓觸壓蓋顧 (製餘積夢糧齋淵糧廠構 )	积极	2020-10-19
ASN2020	临床1期	-	46	Veverimer	壓淵衊願鏇獵糧範窪選(顧鑰構糧積簾觸鹹構鏇) = 獵獵壓鬱糧鏇廠繭膚範淵觸鏇網齋願觸襯簾鏇 (簾鏇獵鏇壓廠顧鏇艱觸 )	积极	2020-10-19
				Omeprazole	壓淵衊願鏇獵糧範窪選(顧鑰構糧積簾觸鹹構鏇) = 積鏇範鹽醖鬱簾鏇夢獵淵觸鏇網齋願觸襯簾鏇 (簾鏇獵鏇壓廠顧鏇艱觸 )
ERA2020	临床3期	慢性肾病	196	Veverimer	壓衊願醖鬱壓憲遞鏇網(襯築淵網選衊蓋艱顧廠) = 壓獵蓋獵糧鏇選鹽糧廠鏇鹹憲醖網選範窪積獵 (壓遞鬱觸襯憲醖構遞鬱 ) 更多	积极	2020-06-06
				Placebo	壓衊願醖鬱壓憲遞鏇網(襯築淵網選衊蓋艱顧廠) = 淵壓憲艱壓艱淵蓋糧襯鏇鹹憲醖網選範窪積獵 (壓遞鬱觸襯憲醖構遞鬱 )