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Bausch Health and Salix to Present at the American Association for the Study of Liver Disease (AASLD) the RED-C Phase 3 Study Design for a New Investigational Product Designed to Address Serious Complications of Cirrhosis

Bausch Health and Salix to Present at the American Association for the Study of Liver Disease (AASLD) the RED-C Phase 3 Study Design for a New Investigational Product Designed to Address Serious Complications of Cirrhosis

bausch health和Salix将在美国肝病研究协会(AASLD)上介绍RED-C 3期研究设计,旨在解决肝硬化的严重并发症的新研究产品。
Accesswire ·  2024/11/18 05:00

Next generation product may increase gastrointestinal luminal concentration while limiting system exposure

下一代产品可以增加胃肠道腔内浓度,同时限制系统暴露

LAVAL, QC / ACCESSWIRE / November 18, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced the first look at its late-stage RED-C clinical trial program which will be presented at the American Association for the Study of Liver Disease (AASLD), The Liver Meeting in San Diego, CA. This clinical program was designed to assess the efficacy of a next generation therapeutic, a soluble solid dispersion (SSD) immediate-release rifaximin product, to delay onset of first overt hepatic encephalopathy (OHE) hospitalization. There are no medications globally approved for the primary prophylaxis and delay in decompensation to first episode of OHE in cirrhosis. Another objective of this study is to assess the effects of treatment with this next generation therapeutic on the time to the onset of significant clinical events, including all-cause hospitalization rates, first occurrence of OHE event requiring hospitalization, and all-cause mortality.

LAVAL, QC / ACCESSWIRE / 2024年11月18日 / Bausch Health Companies Inc.(纽交所:BHC)(tsx:BHC)及其胃肠病学(GI)业务Salix Pharmaceuticals("Salix")今日宣布其晚期RED-C临床试验计划的首次亮相,该计划将在美国肝病研究协会(AASLD)举办的The Liver Meeting上展示。这项临床计划旨在评估一种下一代治疗药物,即可溶性固体分散(SSD)即释利福昔明产品,以延缓首次明显肝性脑病(OHE)住院的发作。目前全球尚无任何药物获批用于肝硬化初发性预防和延缓恶化至首次OHE发作。该研究的另一个目标是评估采用这种下一代治疗药物治疗对首次明显临床事件的发作时间的影响,包括全因住院率、首次需要住院治疗的OHE事件的发生以及全因死亡。

The RED-C program is evaluating a next generation therapeutic designed to enhance the gastrointestinal luminal solubility of a unique form of rifaximin in order to preserve epithelial function, limit bacterial translocation to the bloodstream and liver, and reduce proinflammatory cytokine production. The RED-C program includes two global Phase 3, randomized, double-blind, placebo-controlled studies conducted in over 1,000 patients, over 398 study sites, and across 17 countries. Patient enrollment on both trials is now complete with efficacy and safety results to be announced at future congresses.

RED-C计划正在评估一种下一代治疗药物,旨在增强一种独特形式的利福昔明在胃肠道腔体中的溶解度,以保持上皮功能,限制细菌向血流和肝脏的转位,减少促炎细胞因子的产生。RED-C计划包括两项全球第3期、随机、双盲、安慰剂对照研究,覆盖了超过1,000名患者,在398个研究中心进行,跨越17个国家。两项试验的患者入组现已完成,其疗效和安全性结果将在未来的学术会议上宣布。

"The RED-C program underscores our dedication to exploring and identifying new treatments for individuals with cirrhosis," stated Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. "Considering the significant unmet need for cirrhotic patients, the RED-C phase 3 trials have been rigorously designed to assess a potential new option to delay the onset of the first overt hepatic encephalopathy event, and to potentially, delay time to all-cause hospitalization. Enrollment in both trials is now complete, and the trials are progressing at study sites worldwide."

"RED-C计划强调了我们致力于探索和寻找肝硬化患者新治疗方法的决心," Bausch Health美国药品执行副总裁Aimee Lenar表示。"考虑到肝硬化患者存在的重大未满足需求,RED-C第3期试验已经严格设计,以评估延缓首次明显肝性脑病发作的潜在新选择,并可能延迟全因住院的时间。两项试验的入组现已完成,且该试验在全球范围内的研究中心进行中。"

The Salix research to be presented at AASLD 2024 is as follows:

2024年AASLD将展示的Salix研究如下:

Rifaximin SSD-40IR

利福西明固体分散体即释40mg

  • Bajaj, Jasmohan S. et.al. Rifaximin Soluble Solid Dispersion Immediate-Release Tablets for Prevention and Delay of the First Episode of Hepatic Encephalopathy: RED-C Phase 3 Study Design

    • Poster #4198

    • Monday, November 18, 8:00 AM - 5:00 PM PT

  • Bajaj, Jasmohan S.等人。 利福西明可溶性固体分散体即释片剂用于预防和延迟肝性脑病第一次发作:RED-C第3期研究设计

    • 海报编号#4198

    • 美国东部时间11月18日星期一 上午8:00 - 下午5:00

About Bausch Health

关于Bausch Health

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit and connect with us on LinkedIn.

bausch health公司(纽交所/tsx: BHC)是一家全球多元化的药品公司,通过我们不懈努力提供更好的医疗保健结果来丰富人们的生活。我们主要开发、制造和销售一系列产品,主要涵盖胃肠病学、肝病学、神经病学、皮肤病学、国际药品和眼部健康领域,通过控股Bausch + Lomb公司。我们的雄心是成为一家全球一体化的医疗保健公司,受患者、医护人员、员工和投资者信任和重视。我们的胃肠病学业务Salix Pharmaceuticals是世界上最大的专科药品企业之一,已经授权、开发并销售用于治疗消化系统疾病的创新产品超过30年。有关Salix的更多信息,请访问 官网并在Twitter和LinkedIn上关注我们。有关Bausch Health的更多信息,请访问 官网并在LinkedIn上关注我们。

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2024 Salix Pharmaceuticals or its affiliates.

2024年力拓制药或其关联公司。

XIF.0210.USA.24

XIF.0210.美国.24

SOURCE: Bausch Health Companies Inc.

来源:bausch health公司。


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