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

Fecal microbiota transplantation: present and future. (PubMed, Clin Endosc) - "It has been proven to be highly effective in treating recurrent Clostridioides difficile infection (CDI), and United States Food and Drug Administration-approved microbiome-based therapies, such as REBYOTA (fecal microbiota live-jslm) and VOWST (fecal microbiota spores live-brpk), offer promising treatment options. Emerging therapies such as VE303 (Vedanta) are being studied to refine treatment approaches and expand the use of microbiota-based therapies. Further studies are needed to standardize guidelines, improve patient outcomes, and better define the role of FMT in the treatment of diseases beyond recurrent CDI."

Journal • Review • Infectious Disease • Metabolic Disorders • Transplantation

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) - "Our results suggest that utilizing these therapies early on after the first rCDI would be more cost-effective. VOS was found to be cost-effective compared to RBL for both the first and second rCDI."

Cost effectiveness • HEOR • Infectious Disease

CLINICAL OUTCOMES IN PATIENTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION AFTER MICROBIOTA RESTORATION THERAPY WITH FECAL MICROBIOTA SPORES, LIVE-BRPK (VOWST/VOS) (DDW 2025) - "Background: The management of recurrent Clostridioides difficile infection (rCDI) has significantly evolved since the FDA approval of two live biotherapeutic treatments for prevention of rCDI, including VOWST /VOS and Rebyota...VOS is an oral capsule that may be administered to adult patients after the first or second recurrence of CDI, following antibiotic treatment with either vancomycin or fidaxomicin... VOS was effective in prevention of rCDI with no adverse events reported in long-term follow-up. The efficacy in our cohort was lower than reported in clinical trials, but most of these patients received antibiotics for an indication other than CDI. In patients who receive VOS and must receive an antibiotic following the course of VOS, secondary prophylaxis with oral vancomycin could be considered to reduce the risk of recurrence."

Clinical • Clinical data • Dermatology • Infectious Disease • Nephrology

COMPARING EFFICACY OF BEZLOTOXUMAB, ORAL AND FECAL MICROBIOTA THERAPEUTICS, AND ANTIBIOTICS IN PREVENTING RECURRENT CLOSTRIDIUM DIFFICILE INFECTION: A NETWORK META-ANALYSIS (DDW 2025) - " We conducted a comprehensive search of electronic databases, including PubMed, Cochrane Library, and Embase, to identify Randomized Controlled Trials (RCTs) and Cohort studies from the last 10 years through October 2024 comparing the efficacy of Bezlotoxumab, Fecal Microbiota Transplant (Donor, RebyotaTM), Oral Microbiota Capsules (Donor, VowstTM, VE303TM), Vancomycin, Fidaxomicin, and Rifaximin in preventing recurrent Clostridium difficile infection...In the frequentist network meta-analysis, Actoxumab with Bezlotoxumab (RR=0.61 [0.37; 0.99]), Rebyota™ (RR=0.67 [0.45; 0.99]), VE303 (RR=0.30 [0.09; 0.97]), and Vowst™ (RR=0.29 [0.15; 0.56]) showed a statistically significant reduction in the rate of recurrent Clostridium difficile Infection (rCDI)... This review shows that Vowst™ effectively reduces recurrent Clostridium difficile infection (rCDI) rates compared to placebo and shows more consistent efficacy than other therapies. As an easy-to-use oral capsule, Vowst™ may..."

Retrospective data • 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) - P2, P2b, P3 | "RBL was well tolerated in adults with rCDI across 5 clinical trials. Overall, data demonstrate that RBL has a favorable safety profile, including in participants with IBD and immunocompromising comorbidities."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel 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) - P3 | "Colonoscopic administration of RBL was viewed favorably by physicians, both in terms of patient benefit and practicality of administration in the CDI-SCOPE study."

Clinical • P3 data • Infectious Disease

IMPROVED SYMPTOMS AND HEALTH-RELATED QUALITY OF LIFE IN ADULTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION AFTER FECAL MICROBIOTA, LIVE-JSLM (RBL) ADMINISTRATION BY COLONOSCOPY (DDW 2025) - "The results provide evidence that RBL administered via colonoscopy improves and/or completely resolves diarrhea symptoms in rCDI patients, improving their HRQoL as well as activities of daily living and functioning."

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

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) - P3 | "In this exploratory analysis, RBL administration was correlated with multiple effects beyond clinical resolution of diarrheal disease symptoms, including improved patient-reported mental HRQOL and gut microbiome and metabolome changes."

Clinical • HEOR • P3 data • 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) - P3 | No abstract available

Clinical • P3 data • 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

Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial. (PubMed, Therap Adv Gastroenterol) - P3 | "This single-arm study suggests RBL administered via colonoscopy is practical, safe, and effective for preventing CDI recurrence following antibiotic treatment in adults. ClinicalTrials.gov: NCT05831189."

Journal • P3 data • Critical care • Gastrointestinal Disorder • Infectious Disease

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

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