RBX7455 oral / Ferring - LARVOL DELTA

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: McMaster Children's Hospital | Recruiting ➔ Completed | N=45 ➔ 17 | Trial completion date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2022 ➔ Sep 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • CRP

NCI-2021-027480: RBX7455 Before Surgery for the Treatment of Operable Breast Cancer (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: Mayo Clinic | N=30 ➔ 3 | Trial completion date: Dec 2025 ➔ Jan 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2023 ➔ Jan 2023; poor accrual

Enrollment change • Surgery • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCL2 • ER • HER-2 • IFNG • IL10 • IL17A • IL2 • IL6 • PGR • TNFA

Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy (clinicaltrials.gov) - P2 | N=5 | Terminated | Sponsor: Ochsner Health System | N=75 ➔ 5 | Recruiting ➔ Terminated; Unable to recruit participants

Enrollment change • Trial termination • CNS Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

NCI-2021-027480: RBX7455 Before Surgery for the Treatment of Operable Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2023 ➔ Aug 2023

Enrollment closed • Surgery • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCL2 • ER • HER-2 • IFNG • IL10 • IL17A • IL2 • IL6 • PGR • TNFA

Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: Ochsner Health System | Trial primary completion date: Mar 2023 ➔ Jul 2023

Trial primary completion date • CNS Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

RBX7455 Before Surgery for the Treatment of Operable Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Mayo Clinic | Trial primary completion date: Mar 2022 ➔ Mar 2023

IND • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCL2 • ER • HER-2 • IFNG • IL10 • IL17A • IL2 • IL6 • PGR • TNFA

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: McMaster Children's Hospital | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Jul 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • CRP

Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: Ochsner Health System; Trial completion date: Oct 2022 ➔ Oct 2023; Trial primary completion date: Oct 2021 ➔ Mar 2023; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

Microbiota restoration for recurrent Clostridioides difficile: Getting one step closer every day! (PubMed, J Intern Med) - "Capsule-based therapies include CP101 (positive phase II results), RBX7455 (positive phase I results), SER-109 (positive phase III results) and VE303 (ongoing phase II trial). Enema-based therapy includes RBX2660 (positive phase III data). This review summarizes the principles of management and diagnosis of CDI and focuses on emerging and existing data on faecal microbiota transplantation and standardized microbiota restoration therapies."

Journal • Review • Infectious Disease • Transplantation • PCR

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: McMaster Children's Hospital; Trial completion date: Mar 2020 ➔ Dec 2021; Trial primary completion date: Dec 2019 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics • Transplantation • CRP

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: McMaster Children's Hospital; Trial completion date: Mar 2019 ➔ Mar 2020; Initiation date: Jun 2018 ➔ Oct 2018; Trial primary completion date: Sep 2018 ➔ Dec 2019

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Pediatrics • Transplantation • CRP

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: McMaster Children's Hospital; Not yet recruiting ➔ Recruiting; N=28 ➔ 45

Clinical • Enrollment change • Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • CRP

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: McMaster Children's Hospital; Initiation date: Mar 2018 ➔ Jun 2018

Clinical • Trial initiation date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics • Transplantation • CRP

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: McMaster Children's Hospital; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Jul 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • CRP

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: McMaster Children's Hospital

Clinical • New P1 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics • Transplantation • CRP

Treatment of Recurrent Clostridium Difficile Infection With RBX7455 (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Mayo Clinic; Active, not recruiting ➔ Completed; Trial completion date: Nov 2020 ➔ Jul 2020; Trial primary completion date: Nov 2020 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

Protocol for a double-blind, randomised, placebo-controlled pilot study for assessing the feasibility and efficacy of faecal microbiota transplant in a paediatric Crohn's disease population: PediCRaFT Trial. (PubMed, BMJ Open) - P, P1 | "RBX7455 and RBX2660 are human donor-sourced, microbiota-based therapeutic formulations. The results of this trial will be published in peer-reviewed journals and will help inform a large, multicentre trial in the future. NCT03378167; pre-results."

Clinical • Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Gene Therapies • Immunology • Inflammatory Bowel Disease • Pediatrics • Transplantation

Ferring Pharmaceuticals to Present New Microbiome Research Data at IDWeek 2020 (Businesswire) - "Ferring Pharmaceuticals and Rebiotix today announced they will present two oral abstracts describing studies of investigational non-antibiotic microbiome-based therapeutics (RBX2660 and RBX7455) for the treatment of recurrent Clostridioides difficile (C. diff) infection at IDWeek 2020. The congress will be taking place virtually from October 21-25, 2020. 'We are excited to present these translational microbiome and metabolome analyses from our clinical research program at IDWeek 2020,'..."

Clinical • Immunology • Inflammatory Bowel Disease

[VIRTUAL] Antimicrobial Resistance Genes Are Reduced Following Administration of Investigational Microbiota-based Therapeutic RBX7455 to Individuals with Recurrent clostrioides Difficile Infection (IDWeek 2020) - "In a Phase 1 trial of RBX7455 for rCDI, AMR gene content decreased after treatment. This underscores the potential of microbiota-based therapies for decolonizing AMR bacteria from the gut microbiota. Continued clinical evaluation of RBX7455 is underway."

Clinical • Infectious Disease

RBX7455, a Room Temperature-Stable, Orally-Administered Investigational Live Biotherapeutic, is Safe, Effective, and Shifts Patients' Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections. (PubMed, Clin Infect Dis) - P1 | "Three dosing regimens of RBX7455 were safe and effective at preventing rCDI. Responders' microbiomes converged toward the composition of RBX7455. These results support its continued clinical evaluation."

Clinical • Journal • P1 data

RBX7455: A Pilot Trial of Preoperative Oral Microbiota-based Investigational New Drug (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Mayo Clinic; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • IND • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immune Modulation • Oncology • Solid Tumor • ER • HER-2 • PGR

Evaluation of a prototype microbiome health index for RBX7455: non-frozen, lyophilised, oral microbiota therapy for recurrent Clostridium difficile infection (ECCMID 2019) - "Successful RBX7455 treatment in rCDI patients was associated with significant increases in MHI that approached the MHI of the RBX7455 product, suggesting restoration of a healthier microbiome composition. Furthermore, MHI values and trends pre- and post-RBX7455 treatment are consistent with those reported across two controlled Phase 2 clinical trials for RBX2660, suggesting that MHI can be generalizable among rCDI trials as a possible surrogate endpoint. Figure 1."

RBX7455: A Pilot Trial of Preoperative Oral Microbiota-based Investigational New Drug (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Mayo Clinic; Initiation date: Mar 2020 ➔ Jul 2020

Clinical • IND • Trial initiation date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immune Modulation • Oncology • Solid Tumor • ER • HER-2 • PGR

DEVELOPING MICROBIOME RESTORATION BIOMARKERS FOR CLOSTRIDIUM DIFFICILE INFECTIONS: CONTINUED EVALUATION OF A PROTOTYPE MICROBIOME HEALTH INDEX (UEGW 2018) - "MHI values and trends pre- and post-treatment are consistent across two controlled Phase 2 clinical trials for RBX2660 and one Phase 1 trial of RBX7455, suggesting potential for prospective evaluation of MHI as an exploratory microbiome endpoint. MHI can also effectively distinguish patients with dysbiosis from healthier patients. Significant MHI increases can be measured post-treatment, and in this analysis MHI can differentiate successes from failures at 74 days post-treatment."

Biomarker • Biosimilar • Immunology

A randomised, placebo-controlled pilot trial of faecal microbiota transplantation for paediatric Crohn’s disease (ECCO-IBD 2020) - "Patients will have an initial colonoscopy during which they will receive an infusion into the terminal ileum of normal saline (placebo) or prepared healthy donor stool (RBX2660; Rebiotix, USA) (active). This will be followed by 6-weeks of bi-weekly oral capsular therapy, containing methylcellulose (placebo) or lyophilised healthy adult donor stool (RBX7455; Rebiotix, USA)...This study is novel for its focus on paediatric CD patients, and its use of a combined oral + colonoscopic FMT delivery method. The results of this trial will offer preliminary estimates of efficacy for FMT-based therapies in CD, and may support expansion to a future larger multicenter paediatric RCT using our validated study protocol."

Clinical