Rebyota (fecal microbiota, live-jslm) / Ferring - LARVOL DELTA

Faecal microbiota transplantation for recurrent Clostridiodes difficile infection & its global regulatory landscape. (PubMed, Indian J Med Res) - "Despite being used since millennia, FMT has recently become more well-known and two FMT products, namely Vowst and Rebyota also received FDA approval. The official FMT recommendation for recurrent CDI is emphasised from the perspective of public health, with the argument that early implementation could limit antibiotic overuse and prevent antibiotic resistance. Initiatives like the Universal Stool Bank concept aim to streamline donor selection and distribution procedures to minimise operational restrictions."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Transplantation

Safety and Efficacy of Fecal Microbiota, Live-jslm, in Preventing Recurrent Clostridioides difficile Infection in Participants Who Were Mildly to Moderately Immunocompromised in the Phase 3 PUNCH CD3-OLS Study. (PubMed, Open Forum Infect Dis) - P3 | "Results of this subgroup analysis of PUNCH CD3-OLS suggest that RBL is safe and efficacious for the prevention of rCDI in participants with mildly to moderately immunocompromising conditions. NCT03931941."

Clinical • Journal • P3 data • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

Characteristics and Real-World Outcomes of Patients Treated with Fecal Microbiota, Live-jslm (RBL) for the Prevention of Recurrent Clostridioides difficile Infection. (PubMed, Infect Dis Ther) - "RBL was highly effective in preventing rCDI in a real-world setting, including at-home administration. The effectiveness was also observed among high-risk subgroups, such as patients ≥ 65 years old and those with ≥ 3 prior CDI recurrences."

Journal • Real-world evidence • Infectious Disease • Septic Shock

COST-EFFECTIVENESS ANALYSIS OF FECAL MICROBIOTA SPORES, LIVE-BRPK AND FECAL MICROBIOTA, LIVE-JSLM IN MANAGING FIRST AND SECOND RECURRENCE OF CLOSTRIDIOIDES DIFFICILE INFECTION (DDW 2025) - No abstract available

Cost effectiveness • HEOR • Infectious Disease

CDI-SCOPE: A PHASE 3B MULTI-CENTER, SINGLE-ARM TRIAL EXPLORING THE SAFETY AND EFFECTIVENESS OF FECAL MICROBIOTA, LIVE-JSLM ADMINISTERED BY COLONOSCOPY TO ADULTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION (DDW 2025) - No abstract available

Clinical • P3 data • Infectious Disease

PHYSICIAN EXPERIENCES AND USABILITY OF FECAL MICROBIOTA, LIVE-JSLM (RBL) ADMINISTERED VIA COLONOSCOPY TO ADULTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: ANALYSIS OF A PHASE 3B STUDY (DDW 2025) - No abstract available

Clinical • P3 data • Infectious Disease

IMPROVED SYMPTOMS AND HEALTH-RELATED QUALITY OF LIFE IN ADULTS WITH RECURRENT CLOSTRIDIOIDES DIFFICLE INFECTION AFTER FECAL MICROBIOTA, LIVE-JSLM (RBL) ADMINISTRATION BY COLONOSCOPY (DDW 2025) - No abstract available

Clinical • HEOR • Infectious Disease

SAFETY OF FECAL MICROBIOTA, LIVE-JSLM, IN ADULTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: AN INTEGRATED SAFETY ANALYSIS FROM 5 PROSPECTIVE CLINICAL TRIALS (DDW 2025) - No abstract available

Clinical • Infectious Disease

FECAL MICROBIOTA, LIVE-JSLM AND FECAL MICROBIOTA SPORES, LIVE-BRPK ARE SUPERIOR TO CONVENTIONAL FECAL MICROBIOTA TRANSPLANTATION IN PREVENTING RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION (DDW 2025) - No abstract available

Infectious Disease • Transplantation

HEALTH-RELATED QUALITY OF LIFE IS CORRELATED WITH MICROBIOME AND METABOLOME COMPOSITIONS DURING TREATMENT FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: EXPLORATORY ANALYSIS OF A PHASE 3 STUDY OF FECAL MICROBIOTA, LIVE-JSLM (DDW 2025) - No abstract available

Clinical • HEOR • P3 data • Infectious Disease

Ferring Inc. Receives Health Canada Approval for REBYOTA (fecal microbiota, live) (Canada Newswire) - "Ferring Inc. announced Health Canada has issued a Notice of Compliance, approving REBYOTA (fecal microbiota, live), a novel first-in-class microbiome-restoration therapy indicated for the prevention of recurrence of Clostridioides difficile infection (C. diff) in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff....Health Canada's approval of REBYOTA is based on the results from the clinical program including the randomized, double-blind, placebo-controlled Phase 3 PUNCH CD3 trial."

Canada approval • Infectious Disease

ROAR: REBYOTA™ Prospective Registry (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: Ferring Pharmaceuticals | N=500 ➔ 200 | Trial completion date: Aug 2025 ➔ Apr 2026 | Trial primary completion date: Jul 2025 ➔ Feb 2026

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease

Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS. (PubMed, Inflamm Bowel Dis) - P3 | "The results of this subgroup analysis of PUNCH CD3-OLS suggest RBL is safe and efficacious in patients with IBD."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

CDI-SCOPE: A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection (clinicaltrials.gov) - P3 | N=41 | Completed | Sponsor: Ferring Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

The evolving landscape of live biotherapeutics in the treatment of Clostridioides difficile infection. (PubMed, Indian J Gastroenterol) - "Fecal microbiota, live-jslm and fecal microbiota spores, live-brpk have been approved by the U.S. Food and Drug Administration in individuals aged 18 years or older for recurrent CDI after standard antimicrobial treatment. The review delves into the emerging role of live biotherapeutics, with a particular focus on fecal microbiota-based therapies. We explore their development, mechanisms of action, clinical applications and potential to revolutionize CDI management."

Journal • Review • Infectious Disease • Transplantation

Management of Recurrent Clostridioides difficile Infection (rCDI): A Systematic Literature Review to Assess the Feasibility of Indirect Treatment Comparison (ITC). (PubMed, Infect Dis Ther) - "Fecal-microbiota-based therapies are recommended for rCDI on completion of standard-of-care (SoC) antibiotics to prevent further recurrence: these therapies include conventional fecal-microbiota transplantation and the US Food and Drug Administration-approved therapies REBYOTA® (RBL) and VOWST Oral Spores™ (VOS). As an alternative to microbiota-based therapies, bezlotoxumab, a monoclonal antibody, is used as adjuvant to SoC antibiotics to prevent rCDI...The feasibility analysis determined that trial heterogeneity, particularly relating to inclusion criteria, may significantly compromise ITC and prevent cross-trial comparisons. Our analysis underlines the need to adopt standardized protocols to ensure comparability across trials."

Journal • Review • Infectious Disease • Transplantation

Cost Effective Analysis of Vowst vs Rebyota for the Prevention of Recurrent Clostridium Difficile Infection (ASHP 2024) - No abstract available

Cost effectiveness • HEOR • Infectious Disease

Comparative effectiveness of treatments for recurrent Clostridioides difficile infection: a network meta-analysis of randomized controlled trials. (PubMed, Front Pharmacol) - "Seventeen trials were included, comprising 4,148 CDI patients with ten interventions, including fecal microbiota transplantation (FMT) by lower gastrointestinal (LGI), FMT by upper gastrointestinal (UGI), Autologous FMT (AFMT), vancomycin + FMT, vancomycin, placebo, fidaxomicin, Vowst (SER109), Rebyota (RBX2660), and monoclonal antibody. Antibiotics, in contrast, display comparatively reduced efficacy in rCDI, potentially linked to disruptions in native gut microflora balance. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=368435, Identifier CRD42022368435."

HEOR • Journal • Retrospective data • Review • Gastrointestinal Disorder • Infectious Disease • Transplantation

Real World Experience With Microbiota Treatment for the Prevention of Recurrent Clostridioides difficile Infection (ACG 2024) - "Introduction : Fecal microbiota, live-jslm (RBL) was approved in November 2022 as the first microbiome-based product for the prevention of recurrence of Clostridioides difficile infection (rCDI)...All patients received standard of care antibiotics prior to RBL, with fidaxomicin being most predominant in 39 (58.2%)... 67 rCDI patients received RBL, with a median age of 74 years, IQR (63.0-81.5) and 47% female. The population was highly comorbid with a median Charlson comorbidity score of 4 (IQR 3.0-6.5). Over half (50.7%) had ≥3 recurrences of CDI, 48 (71.6%) were ≥65 years of age and 37 (55.2%) were on gastric acid suppressants."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis

Characteristics and Real-World Outcomes of Patients Treated With Fecal Microbiota, Live-jslm (RBL) for the Prevention of Recurrent Clostridioides difficile Infection (rCDI) (ACG 2024) - "Most patients had received prior antibiotics for rCDI: 36.1% with vancomycin only, 8.3% with fidaxomicin only, 49.1% with both vancomycin and fidaxomicin, and 0.9% with vancomycin, fidaxomicin, and metronidazole. A total of 108 patients had at least 8-week follow up and reported CDI recurrence status at week 8. The median (IQR) age of patients was 64.5 (47.8, 77.0) years, 72.2% were female, 50.0% had commercial or private insurance, and 47.2% had Medicare. Most patients (79.6%) had ≥ 3 prior CDI recurrences, 21.3% had received gastric acid suppressants, 5.6% had received fecal microbiota transplantation previously, and 10.2% had received bezlotoxumab (Table)."

Clinical • Real-world • Real-world evidence • Gastroenterology • Infectious Disease • Septic Shock

Systematic Literature Review and Meta-Analysis of Live Fecal Microbiota Therapeutics for Recurrent Clostridioides Difficile Infection (ACG 2024) - P2b, P3 | " A systematic literature search (SLR) was conducted using the Medline, Embase and Cochrane databases to identify randomized, controlled trials (RCT) examining fecal microbiota therapeutics of interest in patients with rCDIs [fecal microbiota spores, live-brpk (VOS); fecal microbiota live-jslm (RBL)]. Of publications identified in the SLR, 9 reporting results for 3 distinct RCTs (1 for VOS [NCT03183128, N=182 pts] and 2 for RBL [NCT02299570 and NCT03244644, N=350 pts]) were eligible for the NMA. VOS treated pts had greater odds of being recurrence free at 8 weeks compared with RBL pts for the entire population (odds ratio, 3.09 [95% CrI; 1.29, 7.75]; statistically significant), those aged < 65 years (odds ratio, 4.43 [95% Crl; 0.98, 25.71]), and those aged ≥65 years (odds ratio, 2.59 [95% Crl; 0.75, 9.55]). The risk of recurrence over time was significantly less with VOS compared to RBL (hazard ratio, 0.36 [95% CrI; 0.25, 0.53])."

Retrospective data • Review • Gastrointestinal Disorder • Infectious Disease

Real World Outcomes of Fecal Microbiota-Based Therapies to Prevent Recurrent Clostridioides Difficile Infections up to 24 Weeks (ACG 2024) - "We identified 22 patients who received Fecal microbiota, live-jslm, 19 received Fecal microbiota spores, live-brpk, and 90 received conventional FMT for rCDI prevention. Treatment success in preventing rCDI at week 8 was 100%, 89.5%, and 72.2% for Fecal microbiota, live-jslm, Fecal microbiota spores, live-brpk, and conventional FMT, respectively (Figure; p < 0.05, p = 0.13). Clinical cure rate in preventing rCDI at week 24 was 93.8%, 66.7%, and 61.1% for Fecal microbiota, live-jslm, Fecal microbiota spores, live-brpk, and conventional FMT, respectively (p = 0.03, p = 0.71)."

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease

Efficacy of Fecal Microbiota, live-jslm Administered Cecally via Colonoscopy vs Rectally via Enema in Preventing Recurrent Clostridioides difficile Infection (ACG 2024) - P3 | "We identified 22 patients who received fecal microbiota, live-jslm administered using colonoscopy, and there were 180 patients who received fecal microbiota, live-jslm administered rectally in the PUNCH CD3 Trial (See Table). Our efficacy comparison analysis demonstrated that the treatment success rate of fecal microbiota, live-jslm in preventing rCDI was 100% using colonoscopy administration compared to 70.6% using rectal administration (OR = 19.4, 95% C.I 1.16 - 325, p = 0.04). Following those patients who had treatment success at 8-weeks, both groups had equivalent (p = 0.81) sustained clinical response up to 24 weeks (administered via colonoscopy, 93.8%; administered rectally, 92.1%; See Figure)."

Clinical • Gastroenterology • Infectious Disease

Improvement in Health-Related Quality of Life in Adults with Recurrent Clostridioides difficile Infection After Fecal Microbiota, Live-jslm (RBX2660) Administration by Colonoscopy (ACG 2024) - "Data on n=15 interview participants are presented in this interim analysis (participant characteristics in Table 1). All 15 participants (100.0%) completed the 8-week follow-up; none experienced recurrence. Before receiving RBX2660, most reported diarrhea as the most bothersome (66.7%) and the most important symptom (70.0%) to resolve."

Clinical • HEOR • Fatigue • Gastroenterology • Infectious Disease • Sleep Disorder

Characteristics and Real-world Outcomes of Patients Administered with Fecal Microbiota, live-jslm for the Prevention of Recurrent Clostridioides difficile Infection (rCDI) (IDWeek 2024) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease