RBT-1 as a preconditioning agent has the potential to provide patient benefits in multiple surgical settings where organ injury during surgery increases the risk of post-operative complications

RBT-1作为预处理剂有可能在多种手术环境中为患者提供益处，因为手术过程中的器官损伤会增加术后并发症的风险

Phase 3 PROTECT study ongoing, top line data anticipated Q3 2025

第三阶段保护研究正在进行中，预计2025年第三季度的顶线数据

SOUTHLAKE, Texas, Jan. 9, 2024 /PRNewswire/ -- Renibus Therapeutics® ('Renibus'), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced publication in E-Clinical Medicine, part of The Lancet Discovery Science, of results from the Phase 2 study evaluating RBT-1, the Company's first-in-a-new-class preconditioning agent, under investigation to reduce post-operative complications following cardiothoracic surgery.  .

德克萨斯州南湖，2024年1月9日/PRNewswire/-Renibus Therapeutics®（“Renibus”）是一家专注于预防和治疗心脏、肾脏和代谢疾病的临床阶段生物制药公司，今天宣布在《柳叶刀发现科学》的一部分《电子临床医学》上发表了评估RBT-1的第二阶段研究结果，该公司的新型一流预处理剂正在研究中，以减少心胸外科手术后的并发症。。

'The publication of our Phase 2 manuscript provides validation of the importance of RBT-1 as a novel pre-conditioning agent in the cardiothoracic surgery field, as well as a powerful way to reach the key surgeons and providers as we continue through Phase 3 and prepare for commercialization,' said Frank Stonebanks, Co-CEO of Renibus.  'We believe that RBT-1 has broad 'pipeline-in-a-product' potential, and we look forward to bringing our product to patients in need.'.

Renibus联合首席执行官弗兰克·斯通班克斯（FrankStonebanks）说：“我们第二阶段手稿的出版验证了RBT-1作为心胸外科领域新型预处理剂的重要性，也是我们继续进行第三阶段并准备商业化时接触关键外科医生和提供者的有力途径。”。“我们相信RBT-1具有广泛的“产品中的管道”潜力，我们期待着将我们的产品带给有需要的患者。”。

RBT-1 (stannic protoporfin/iron sucrose), a fixed dose combination product given once intravenously over 1-2 hours, 24-48 hours before surgery, is a potent inducer of anti-inflammatory, antioxidant and iron-scavenging pathways. In a completed Phase 2 study, RBT-1 demonstrated statistically significant positive data in primary and several clinical endpoints, including reduced time in the ICU, shortened patient recovery time and fewer hospital readmissions. .

RBT-1（锡原卟啉/蔗糖铁）是一种固定剂量的组合产品，在手术前24-48小时，在1-2小时内静脉注射一次，是抗炎，抗氧化和铁清除途径的有效诱导剂。在一项完成的2期研究中，RBT-1在主要和几个临床终点显示出统计学上显着的阳性数据，包括减少ICU时间，缩短患者恢复时间和减少再入院。。

'Having our data showcased in one of the world's most prestigious medical journals underscores the potential of RBT-1's mechanism of action to revolutionize the treatment paradigm for patients undergoing cardiothoracic surgery,' added Bhupinder Singh, Chief Medical Officer of Renibus.  'For the first time in history, a potential new treatment option presents the possibility of reducing complications from cardiothoracic surgery – such as time in the ICU, time on a ventilator and 30-day cardiopulmonary readmission rates, while reducing the economic burden on the healthcare system.'.

Renibus首席医疗官布宾德·辛格（Bhupinder Singh）补充道：“我们的数据在世界上最负盛名的医学期刊之一上展示，突显了RBT-1的作用机制在彻底改变心胸外科患者治疗模式方面的潜力。”。“有史以来第一次，一种潜在的新治疗选择提供了减少心胸外科手术并发症的可能性，例如入住ICU的时间，使用呼吸机的时间和30天的心肺再入院率，同时减轻了医疗保健系统的经济负担。”。

The Phase 2 study of RBT-1 was a multicenter, double-blind, placebo controlled, Phase 2 clinical trial in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery on cardiopulmonary bypass (CPB). The trial enrolled 152 patients from cardiac surgery centers in the US, Canada and Australia, 132 patients were evaluable for the primary endpoint (ITT population) and 121 were evaluable for clinical outcomes (mITT population), as pre-specified in the statistical analysis plan..

RBT-1的2期研究是一项多中心，双盲，安慰剂对照的2期临床试验，用于接受冠状动脉旁路移植术（CABG）和/或体外循环（CPB）心脏瓣膜手术的患者。该试验招募了来自美国，加拿大和澳大利亚心脏外科中心的152名患者，132名患者可评估主要终点（ITT人群），121名患者可评估临床结果（mITT人群），如统计分析计划中预先规定的。。

The published manuscript, titled 'Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial', is available online and will appear in the print issue of The Lancet at a later date..

已发表的手稿名为“RBT-1对接受冠状动脉旁路移植术或心脏瓣膜手术的患者预处理反应生物标志物的影响：一项多中心，双盲，随机，安慰剂对照的2期临床试验”，可在线获得，并将于晚些时候在《柳叶刀》的印刷版上发表。。

About RBT-1 and the PROTECT Phase 3 Study

关于RBT-1和PROTECT 3期研究

Renibus' first-in-a-new-class lead program, RBT-1 (stannic protoporfin/iron sucrose), is 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. RBT-1 has started its Phase 3 US registrational study [NCT # 06021457] to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery.

Renibus的一流领先项目RBT-1（锡原卟啉/蔗糖铁）是一种单剂量IV药物，在患者接受选择性心脏手术前1-2小时，24-48小时服用。RBT-1已开始其第三阶段美国注册研究[NCT#06021457]，以降低术后并发症的风险并改善心胸外科手术后的预后。

The drug has received FDA Breakthrough and Fast Track Designations..

该药物已获得FDA突破和快速通道指定。。

PROTECT is a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery.  The study is a randomized, double-blind, multi-center, placebo-controlled trial evaluating the effect of RBT-1 in approximately 400 patients.  The primary endpoint is a severity-based composite hierarchy using the Win-Ratio or Finkelstein-Schoenfeld Method that includes the following: death, AKI requiring dialysis, ICU days, and 30-day cardiopulmonary readmission rates.   Secondary and exploratory objectives include time on the ventilator, need for blood products, new onset atrial fibrillation, delirium, hospital length of stay, cost effective analyses and safety.

PROTECT是一项3期随机双盲安慰剂对照研究，旨在评估RBT-1对降低心脏手术受试者术后并发症风险的作用。这项研究是一项随机，双盲，多中心，安慰剂对照试验，评估了RBT-1对大约400名患者的影响。主要终点是使用Win Ratio或Finkelstein-Schoenfeld方法的基于严重程度的复合层次结构，包括以下内容：死亡，需要透析的AKI，ICU天数和30天的心肺再入院率。次要和探索性目标包括呼吸机使用时间，对血液制品的需求，新发心房颤动，deli妄，住院时间，成本效益分析和安全性。

Top line results are expected mid-2025..

预计2025年年中将取得最佳结果。。

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' 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.

Renibus是一家临床阶段的生物制药公司，致力于通过开发产品来预防疾病进展，改善预后并防止与心脏，肾脏和代谢疾病相关的器官损伤，从而治疗，改善和延长患者的生命。Renibus的新型领先项目是RBT-1（锡原卟啉/蔗糖铁），这是一种单剂量IV药物，在接受选择性心脏和/或瓣膜手术的患者之前1-2小时，24-48小时内给予。

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 (Alezuris™) is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida.

这是一项3期关键试验，旨在降低术后并发症的风险并改善心胸外科手术后的结果。该药物已获得FDA突破和快速通道指定。维维里默（Alezuris™) 是一种从Tricida获得的口服非吸收盐酸粘合剂。

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 a Phase 2 trial. RBT-3 (iron sucrose), one component of RBT-1, is a novel, low molecular weight iron nanoparticle that has the potential to rapidly restore iron levels and improve blood product utilization in cardiac surgery and/or ER patients.  RBT-3 has also demonstrated the potential to mitigate cisplatin induced nephrotoxicity in preclinical models.

我们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征，目的是确定在2期试验中进行评估的指征。RBT-3（蔗糖铁）是RBT-1的一种成分，是一种新型的低分子量铁纳米颗粒，具有快速恢复铁水平和提高心脏手术和/或ER患者血液制品利用率的潜力。RBT-3还证明了在临床前模型中减轻顺铂诱导的肾毒性的潜力。

We are currently exploring opportunities to further the clinical development of RBT-3 in these potential indications. RBT-9 (stannic protoporfin), another component of RBT-1, is a potent anti-inflammatory and antioxidant drug. It has completed Phase 1 (as part of the RBT-1 program) and has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19.

我们目前正在探索在这些潜在适应症中进一步发展RBT-3临床开发的机会。RBT-9（锡原卟啉）是RBT-1的另一种成分，是一种有效的抗炎和抗氧化药物。它已经完成了第一阶段（作为RBT-1计划的一部分），并在42名患者的第二阶段随机安慰剂对照试验中对高危COVID-19患者进行了调查。

The data from this tria.

来自此tria的数据。

For more information, please visit the Company's website at www.Renibus.com and engage with us on LinkedIn.

欲了解更多信息，请访问公司网站www。Renibus.com并在LinkedIn上与我们联系。

Investor and Media Contact:

投资者和媒体联系人：

Amy ConradJuniper Point[email protected]858-914-1962

Amy ConradJuniper Point[受电子邮件保护]858-914-1962

Business Development Contact

业务发展联系人

Frank StonebanksCo-CEO, Renibus[email protected]

Frank StonebanksCo首席执行官，Renibus[受电子邮件保护]

SOURCE Renibus Therapeutics

来源Renibus Therapeutics