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 Pharmaceuticals announced the presentation of their RED-C Phase 3 clinical trial program at AASLD. The study evaluates a next-generation soluble solid dispersion (SSD) immediate-release rifaximin product designed to delay the onset of first overt hepatic encephalopathy (OHE) hospitalization in cirrhosis patients. The program consists of two global Phase 3 trials involving over 1,000 patients across 398 study sites in 17 countries. Patient enrollment is complete, with efficacy and safety results pending. The therapeutic aims to enhance gastrointestinal luminal solubility while limiting systemic exposure, addressing an unmet medical need as there are currently no approved medications for primary prophylaxis of OHE in cirrhosis.
Bausch Health e Salix Pharmaceuticals hanno annunciato la presentazione del loro programma di studio clinico RED-C di Fase 3 all'AASLD. Lo studio valuta un prodotto a rilascio immediato di rifaximina a dispersione solida solubile di nuova generazione, progettato per ritardare l'insorgenza del primo ricovero per encefalopatia epatica overt (OHE) nei pazienti affetti da cirrosi. Il programma consiste in due studi globali di Fase 3 che coinvolgono oltre 1.000 pazienti in 398 siti di studio in 17 paesi. L'arruolamento dei pazienti è completato, mentre i risultati di efficacia e sicurezza sono in attesa. La terapia mira a migliorare la solubilità nel lume gastrointestinale, limitando nel contempo l'esposizione sistemica, affrontando un'esigenza medica insoddisfatta, poiché attualmente non ci sono farmaci approvati per la profilassi primaria dell'OHE nella cirrosi.
Bausch Health y Salix Pharmaceuticals anunciaron la presentación de su programa de ensayo clínico RED-C de Fase 3 en la AASLD. El estudio evalúa un producto de rifaximina de liberación inmediata en forma de dispersión sólida soluble de nueva generación, diseñado para retrasar la aparición de la primera hospitalización por encefalopatía hepática overt (OHE) en pacientes con cirrosis. El programa consta de dos ensayos globales de Fase 3 que involucran a más de 1,000 pacientes en 398 sitios de estudio en 17 países. La inscripción de pacientes está completa, con resultados de eficacia y seguridad pendientes. La terapia tiene como objetivo mejorar la solubilidad luminal gastrointestinal mientras limita la exposición sistémica, abordando una necesidad médica no satisfecha, ya que actualmente no hay medicamentos aprobados para la profilaxis primaria de OHE en la cirrosis.
바우슈 헬스(Bausch Health)와 살릭스 제약(Salix Pharmaceuticals)은 AASLD에서 RED-C 3상 임상 시험 프로그램 발표를 알렸습니다. 이 연구는 간경변 환자에서 첫 번째 외현성 간성 혼수(OHE) 입원의 시작을 지연시키도록 설계된 차세대 용해성 고형 분산체(SSD) 즉시 방출 리파시민 제품을 평가합니다. 이 프로그램은 17개국의 398개 연구 사이트에서 1,000명 이상의 환자가 참여하는 3상 글로벌 시험 두 개로 구성됩니다. 환자 등록은 완료되었으며, 유효성 및 안전성 결과는 대기 중입니다. 이 치료법은 장내 용해도를 향상시키고 전신 노출을 제한하여 간경변에 대한 OHE의 1차 예방을 위한 승인된 약물이 현재 존재하지 않는 unmet medical need를 해결하는 것을 목표로 합니다.
Bausch Health et Salix Pharmaceuticals ont annoncé la présentation de leur programme d'essai clinique RED-C de Phase 3 lors de l'AASLD. L'étude évalue un produit de rifaximine à libération immédiate en dispersion solide soluble de nouvelle génération, conçu pour retarder l'apparition de la première hospitalisation pour encéphalopathie hépatique overt (OHE) chez les patients atteints de cirrhose. Le programme se compose de deux essais mondiaux de Phase 3 impliquant plus de 1 000 patients dans 398 sites d'étude dans 17 pays. L'inscription des patients est complète, avec les résultats d'efficacité et de sécurité en attente. Ce traitement vise à améliorer la solubilité dans la lumière gastro-intestinale tout en limitant l'exposition systémique, répondant à un besoin médical non satisfait, car il n'existe actuellement aucun médicament approuvé pour la prophylaxie primaire de l'OHE en cas de cirrhose.
Bausch Health und Salix Pharmaceuticals haben die Präsentation ihres RED-C Phase 3-Studienprogramms auf der AASLD angekündigt. Die Studie bewertet ein nächstgenerationsfähiges sofort freisetzendes Rifaximin-Produkt in löslicher Feststoffdispersion (SSD), das darauf abzielt, den Beginn der ersten manifeste hepatische Enzephalopathie (OHE)-Hospitalisierung bei Patienten mit Zirrhose zu verzögern. Das Programm besteht aus zwei globalen Phase 3-Studien mit über 1.000 Patienten an 398 Studienstandorten in 17 Ländern. Die Patienteneinschreibung ist abgeschlossen, während die Ergebnisse zu Wirksamkeit und Sicherheit noch ausstehen. Die Therapie zielt darauf ab, die luminale Löslichkeit im Gastrointestinaltrakt zu verbessern und gleichzeitig die systemische Exposition zu begrenzen, um ein ungedecktes medizinisches Bedürfnis anzugehen, da es derzeit keine zugelassenen Medikamente zur primären Prophylaxe von OHE bei Zirrhose gibt.
- Completed enrollment for two large-scale Phase 3 clinical trials
- Addresses unmet medical need with no current approved treatments
- Large study scope with 1,000+ patients across 398 sites in 17 countries
- None.
Insights
The RED-C Phase 3 clinical trial program represents a significant development in liver disease treatment. This study focuses on a novel formulation of rifaximin using soluble solid dispersion (SSD) technology, targeting a critical unmet medical need in cirrhosis treatment. The trial's scope is impressive, encompassing over 1,000 patients across 398 sites in 17 countries.
The program's primary goal of preventing first-episode hepatic encephalopathy (OHE) hospitalization addresses a important gap in current treatment options. The completion of patient enrollment is a major milestone, suggesting results could be available in the near term. The dual Phase 3 trial design and large patient population strengthen the statistical validity of any potential outcomes.
For BHC investors, this represents a significant potential market opportunity, as there are currently no approved medications globally for primary prophylaxis of OHE in cirrhosis patients. A successful outcome could establish Bausch Health as a leader in this therapeutic area and potentially create a new revenue stream.
Next generation product may increase gastrointestinal luminal concentration while limiting system exposure
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.
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.
"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."
The Salix research to be presented at AASLD 2024 is as follows:
Rifaximin SSD-40IR
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
About 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 www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
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SOURCE: Bausch Health Companies Inc.
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