Renibus Therapeutics宣布完成PROTECT的入组工作，这是一项关键的RBT-1三期临床试验，旨在降低心脏手术后术后并发症的风险-动脉网

Renibus Therapeutics Announces Completion of Enrollment in PROTECT, a Pivotal Phase 3 Clinical Trial of RBT-1 to Reduce the Risk of Post-Operative Complications After Cardiac Surgery

CISION 等信源发布 2025-04-24 19:59

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- Topline results expected in Q3 2025 -

- 顶线结果预计在2025年第三季度 -

SOUTHLAKE, Texas

南湖，德克萨斯州

，

April 24, 2025

2025年4月24日

/PRNewswire/ -- Renibus Therapeutics

('Renibus'), a clinical late-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced the completion of enrollment (n=400) in PROTECT, a pivotal Phase 3 trial evaluating the effect of RBT-1 on reducing the risk of post-operative complications in patients undergoing cardiac surgery (.

Renibus公司是一家专注于预防和治疗心脏、肾脏及代谢疾病的临床后期生物制药公司，今天宣布了在其关键的三期试验PROTECT中完成了400名患者的入组，该试验旨在评估RBT-1在降低心脏手术患者术后并发症风险方面的效果。

NCT06021457

). The trial enrolled 423 patients across 40 trial sites in

）。该试验在40个试验地点共招募了423名患者。

the United States

美国

(US) and

（美国）和

Canada

加拿大

. Topline results from the study are anticipated in third quarter of this year.

预计将在今年第三季度公布该研究的初步结果。

继续阅读

(PRNewsfoto/Renibus Therapeutics)

（PRNewsfoto/Renibus Therapeutics）

RBT-1 (stannic protoporfin/iron sucrose) is a single-dose, first-in-class, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing non-emergent cardiac surgery. Renibus previously completed a Phase 2 trial of RBT–1 (NCT04564833) in

RBT-1（锡原卟啉/蔗糖铁）是一种单剂量、首创新药的预处理剂，在患者进行非紧急心脏手术前24至48小时通过静脉注射给药。Renibus此前已完成RBT-1（NCT04564833）的二期临床试验。

February 2023

2023年2月

and announced positive results from this trial in

并宣布了这项试验的积极结果

May 2023

2023年5月

. RBT-1 has received Breakthrough Therapy and Fast Track Designations from the FDA.

RBT-1 已获得 FDA 的突破性疗法和快速通道资格。

'The achievement of full enrollment in the PROTECT trial is a major milestone for Renibus, and I couldn't be more grateful for the dedication of our Renibus team who accomplished this goal ahead of schedule,' stated

“PROTECT试验实现全额入组是Renibus的一个重要里程碑，我对我们Renibus团队提前完成这一目标的奉献精神感激不尽，”

Donald Jeffrey Keyser

唐纳德·杰弗里·凯泽

, R.Ph., J.D., Ph.D., President and CEO of Renibus. 'We believe that RBT-1 has the potential to transform the treatment landscape of cardiac surgery by reducing the risk of post-surgical complications.'

，R.Ph.，J.D.，Ph.D.，Renibus总裁兼首席执行官。“我们相信RBT-1有潜力通过降低术后并发症的风险来改变心脏手术的治疗前景。”

'On behalf of Renibus and the clinical study team, I would like to thank the patients and study investigators who supported this important study,' stated Renibus' Chief Medical Officer,

“代表Renibus和临床研究团队，我要感谢支持这项重要研究的患者和研究者，”Renibus首席医学官表示。

Bhupinder Singh

布平德·辛格

, M.D., F.A.S.N., F.N.K.F.

，医学博士，美国肾病学会会员，美国国家肾脏基金会会员。

Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Indianapolis added, 'RBT-1 has shown great potential in clinical studies to reduce serious complications that arise following cardiac surgery. I am encouraged that PROTECT enrolled so quickly, which underscores the large unmet medical need to prevent complications following the entire spectrum of heart surgeries.

Franciscan Health印第安纳波利斯心血管外科主任马克·格迪施 (Marc Gerdisch) 博士补充说：“RBT-1在临床研究中显示出减少心脏手术后出现的严重并发症的巨大潜力。PROTECT的迅速招募让我备受鼓舞，这突显了预防各类心脏手术后并发症这一巨大且未满足的医疗需求。”

Soon we will better understand the promise of improved outcomes RBT-1 may provide our patients.'.

很快我们将更好地理解RBT-1可能为我们的患者提供的改善结果的希望。

The lack of drug therapies targeting the reduction in risk of post-operative complications following cardiac surgery represents a significant unmet medical need. In

心脏手术后缺乏针对降低术后并发症风险的药物治疗，这代表了一个重要的未满足医疗需求。在

the United States

美国

, there are approximately 250,000 cardiac surgeries, with approximately two thirds of patients having post-operative complications that impact long-term outcomes and drives increased cost to the healthcare system. RBT-1, if approved, would be the first and only pharmacological therapy on the market to reduce the risk of post-operative complications following cardiac surgery..

，大约有 25 万台心脏手术，其中大约三分之二的患者存在影响长期预后的术后并发症，这增加了医疗保健系统的成本。RBT-1 如果获批，将成为市面上首个也是唯一一个降低心脏手术后术后并发症风险的药物疗法。

'As critical care physicians, we are focused on reducing the cost of patient services and lowering the economic burden on the healthcare ecosystem. In treating cardiothoracic surgical patients, almost two-thirds of patients will have complications following surgery which leads to further hospitalizations, increased time in the ICU, and longer-term health concerns,' said .

“作为重症监护医生，我们专注于降低患者服务的成本，减轻医疗保健生态系统的经济负担。在治疗心胸外科患者时，几乎三分之二的患者会在手术后出现并发症，这会导致再次住院、ICU停留时间增加以及更长期的健康问题，”他表示。

Ashish Khanna M.D

阿希什·卡纳医学博士

., F.C.C.P., F.C.C.M., Professor, Vice Chair of Research Department of Anesthesiology, Section on Critical Care Medicine, Wake Forest School of Medicine, Atrium Health Wake Forest Baptist Medical. 'I am excited about the potential for RBT-1 to improve patient outcomes and reduce healthcare costs.'

., F.C.C.P., F.C.C.M., 教授，麻醉学系研究副主任，重症医学科，维克森林医学院，Atrium Health 维克森林浸信会医疗中心。 “我对 RBT-1 改善患者预后和降低医疗成本的潜力感到兴奋。”

About RBT-1

关于RBT-1

RBT-1 is a potent inducer of anti-inflammatory and antioxidant pathways and is currently being evaluated to reduce post-operative complications following cardiac surgery (

RBT-1 是一种有效的抗炎和抗氧化通路诱导剂，目前正在评估其在心脏手术后减少术后并发症的作用 (

NCT06021457

). Previously, Renibus completed the Phase 2 trial of RBT-1 (NCT04564833) in

）。此前，Renibus 已完成 RBT-1（NCT04564833）的二期试验，

February 2023

2023年2月

and announced positive final results from this trial in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal trial and announced completion of enrollment in

并在2023年5月公布了该试验的积极最终结果。2023年10月，Renibus启动了其PROTECT第三阶段关键试验中RBT-1的入组和给药，并宣布完成入组。

April 2025

2025年4月

。

RBT-1 has been granted Breakthrough Therapy and Fast Track Designations by the Division of Cardiology and Nephrology at the FDA.

RBT-1 已获得 FDA 心脏病学和肾病学部门授予的突破性疗法和快速通道资格。

About PROTECT

关于PROTECT

PROTECT is a

保护是一个

hase 3,

第三阶段，

and

和

mized, Double-Blind, Placebo-Controlled S

混合的、双盲的、安慰剂对照的 S

udy to

研究到

valuate the Effect of RBT-1 on Reducing the Risk of Post-Operative

评估RBT-1在降低术后风险方面的效果

C语言

omplica

并发症

ions in Subjects Undergoing Cardiac Surgery. The primary endpoint of this pivotal phase 3 study is a composite of death, AKI requiring dialysis, ICU days, and 30-day cardiopulmonary readmission rates, evaluated based upon severity, using the Win-Ratio Method. Secondary and exploratory objectives include time on the ventilator, need for blood products, new onset atrial fibrillation, hospital length of stay, cost effective analyses and safety. .

接受心脏手术的受试者中的离子。这项关键的第三阶段研究的主要终点是死亡、需要透析的急性肾损伤（AKI）、重症监护室（ICU）天数和30天内心肺再入院率的复合指标，并根据严重程度使用Win-Ratio方法进行评估。次要和探索性目标包括呼吸机使用时间、血液制品的需求、新发房颤、住院时间、成本效益分析和安全性。

About Renibus Therapeutics

关于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是一家临床阶段的生物制药公司，致力于通过开发预防疾病进展、改善结果和保护心脏、肾脏和代谢疾病相关器官损伤的产品来治疗、改善和延长患者的生命。

Renibus' lead first-in-class combination drug therapy is RBT-1, a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac surgery. RBT-1 has just completed a Phase 3 pivotal trial (called PROTECT) measuring its primary objective to reduce the risk of post operative complications and improve outcomes following cardiac surgery..

Renibus公司的领先首创联合药物疗法是RBT-1，这是一种单剂量静脉注射药物，在患者接受择期心脏手术前24至48小时给予，输注时间为1至2小时。RBT-1刚刚完成了一项名为PROTECT的III期关键试验，该试验评估了其主要目标——降低术后并发症风险并改善心脏手术后的预后。

Renibus acquired veverimer, a late-stage clinical asset. Veverimer is an oral, non-absorbed hydrochloric acid binder. Renibus is 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收购了处于临床后期阶段的资产veverimer。Veverimer是一种口服、不被吸收的盐酸结合剂。Renibus目前正在临床前模型中评估veverimer，并分析历史数据，以进一步了解其临床特性，目标是确定一个适应症用于临床试验评估。

For more information, please visit the Company's website at

欲了解更多信息，请访问公司网站

www.Renibus.com

and engage with us on LinkedIn.

在LinkedIn上与我们互动。

Investor and Media Contact:

投资者和媒体联系人：

Amy Conrad

艾米·康拉德

Juniper Point

杜松点