Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of …

S Khanna, M Assi, C Lee, D Yoho, T Louie, W Knapple… - Drugs, 2022 - Springer
Abstract Background Recurrent Clostridioides difficile infection, associated with dysbiosis of
gut microbiota, has substantial disease burden in the USA. RBX2660 is a live biotherapeutic …

Utility of human relevant preclinical animal models in navigating NAFLD to MAFLD paradigm

D Chua, ZS Low, GX Cheam, AS Ng… - International Journal of …, 2022 - mdpi.com
Fatty liver disease is an emerging contributor to disease burden worldwide. The past
decades of work established the heterogeneous nature of non-alcoholic fatty liver disease …

Targeting Th17 cells in HIV-1 remission/cure interventions

A Fert, LR Marchand, TRW Salinas, P Ancuta - Trends in Immunology, 2022 - cell.com
Since the discovery of HIV-1, progress has been made in deciphering the viral replication
cycle and mechanisms of host–pathogen interactions that has facilitated the implementation …

Fecal microbiota transplantation for treatment of Parkinson disease: a randomized clinical trial

F Scheperjans, R Levo, B Bosch, M Lääperi… - JAMA …, 2024 - jamanetwork.com
Importance Dysbiosis has been robustly demonstrated in Parkinson disease (PD), and fecal
microbiota transplantation (FMT) has shown promising effects in preclinical PD models …

Practical use of RBX2660 for the prevention of recurrent Clostridioides difficile infection

P Feuerstadt, JR Allegretti… - Official journal of the …, 2023 - journals.lww.com
BACKGROUND Clostridioides difficile infection (CDI) remains a major public health threat in
the United States with an estimated 365,000 individuals being diagnosed annually, with …

Retrospective Analysis of the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTATM) administered under enforcement discretion to patients with …

P Feuerstadt, A Harvey, DS Yoho… - Open Forum …, 2023 - academic.oup.com
Background Fecal microbiota, live-jslm (RBL; REBYOTA™), the first microbiota-based live
biotherapeutic approved by the US Food and Drug Administration to prevent recurrent …

Therapeutics for Clostridioides difficile infection: molecules and microbes

S Khanna, E Voth - Expert Review of Gastroenterology & …, 2023 - Taylor & Francis
Introduction Clostridioides difficile infection (CDI) is a major healthcare problem in the
developed world, and effective management of recurrent infection remains one of the …

The Role of Microbiome-Based Therapeutics in Clostridioides difficile Infection: Durable, Long-Term Results of RBX2660

R Orenstein - Infectious Diseases and Therapy, 2023 - Springer
A recently published manuscript described findings from a phase 2 open label study of the
microbiota-based live biotherapeutic product RBX2660 in patients with two or more previous …

Resolution rates in clinical trials for microbiota restoration for recurrent Clostridioides difficile infection: an updated systematic review and meta-analysis

R Tariq, DS Pardi, S Khanna - Therapeutic Advances in …, 2023 - journals.sagepub.com
Background: Microbiota restoration is highly effective to treat recurrent Clostridioides difficile
infection (CDI) in observational studies (cure rates> 90%) but efficacy in controlled clinical …

Fecal microbiota, live-jslm for the prevention of recurrent Clostridioides difficile infection: subgroup analysis of PUNCH CD2 and PUNCH CD3

P Feuerstadt, CV Crawford, X Tan… - Journal of Clinical …, 2024 - journals.lww.com
Background: RBL is the first microbiota-based live biotherapeutic approved by the US Food
and Drug Administration for the prevention of rCDI in adults after antibiotic treatment for …