Vowst (fecal microbiota spores, live-brpk) / Seres Therap, Nestle - LARVOL DELTA

Diagnosis and Management of C. difficile. (PubMed, Am J Gastroenterol) - "Treatment paradigms are discussed across the spectrum of disease severity, with vancomycin and fidaxomicin as first-line therapies and the diminishing role of metronidazole. For recurrent CDI, newer fecal microbiota-based therapies, including Fecal Microbiota, live-jslm (Rebyota, RBL) and Fecal Microbiota Spores, live-brpk (Vowst, VOS), are reviewed. The role of conventional fecal microbiota transplantation (FMT), particularly in fulminant CDI, is also addressed, including challenges resulting from FDA policies around stool bank material. We aim to clarify diagnostic and therapeutic approaches and optimize care for patients with CDI."

Journal • Infectious Disease • Transplantation

Comparison of the Efficacy and Safety of Live Fecal Microbiota Therapeutics for Recurrent Clostridioides difficile Infection (CDI): Matching-Adjusted Indirect Treatment Comparison in Patients With ≥1 CDI Recurrence (ACG 2025) - "The orally administered fecal microbiota spores, live-brpk (VOS) and rectally administered fecal microbiota, live-jslm (RBL), with different compositions, are both FDA-approved for any patients with rCDI. Of the 33 publications identified in the SLR, six, reporting on two distinct studies including patients with ≥1 recurrent episode were deemed eligible for the MAIC. VOS was significantly more efficacious than RBL in preventing rCDI at 8 weeks (odds ratio [OR]; 9.23 [95% confidence interval (CI): 4.24, 20.08]). The time to recurrence over time was significantly lower with VOS compared with RBL (hazard ratio; 0.19 [95% CI; 0.10, 0.33])."

Clinical • Infectious Disease

Efficacy of Fecal Microbiota Transplant for Prevention of Recurrent CDI in Patients Diagnosed With Cancer (ACG 2025) - "Vancomycin and fidaxomicin were the most frequently used antibiotics, and 18.8% received bezlotoxumab.Colonoscopy-delivered FMT was the most common intervention (68.1%), followed by Rebyota (17.4%) and VOWST (7.2%); combination strategies were used in 7.2%. A total of 69 patients with a history of CDI or rCDI were included. Hematologic malignancies were the most common cancer type (29.6%), and nearly half had stage III–IV disease. At the time of their most recent CDI episode, 55% were receiving active cancer therapy."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Oncology • Transplantation

Microbiota-Based Therapies for Recurrent Clostridium difficile Infection: A Systematic Review of Their Efficacy and Safety. (PubMed, Cureus) - "Donor FMT outperformed autologous FMT (90.9% vs. 62.5%, p = 0.042) and standard therapies (71% resolution vs. 33% fidaxomicin/19% vancomycin, p < 0.01). Donor-derived interventions and pharmaceutical-grade products (SER-109, RBX2660) represent promising alternatives to traditional antibiotics, particularly in recurrent or refractory cases. Future research should aim to standardize protocols and include more high-risk populations."

Journal • Review • Infectious Disease • Transplantation

Identification and Analysis of Asymptomatic Pathogen Carriage in Stool Donors for Manufacturing of the Microbiome Therapeutic, Fecal Microbiota Spores, live-brpk (IDWeek 2025) - No abstract available

Infectious Disease

Real World Utilization of Live-brpk (VOWST) among Patients with Recurrent Clostridioides difficile Infection: Single Center Experience (IDWeek 2025) - No abstract available

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

What's New and What's Next in Fecal Microbiota Transplantation? (PubMed, Biologics) - "In recent years, the FDA approved two standardized microbiota-based therapeutics-Rebyota™ (fecal microbiota, live-jslm) and Vowst™ (fecal microbiota spores, live-brpk)-for rCDI prevention. Meanwhile, regulatory pathways and clinical guidelines for microbiota-derived biologics and live biotherapeutic products continue to evolve. In this manuscript, we provide an update on the emerging use of FDA-approved prescription microbiota-derived therapeutics for the prevention of rCDI, review data on investigational agents including both donor dependent and donor independent microbial products, and summarize current evidence on the use of conventional FMT for indications beyond prevention of rCDI."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Transplantation

Comparability of gastrointestinal microbiome and bile acid profiles in patients with first or multiply recurrent Clostridioides difficile infection. (PubMed, J Infect Dis) - "These data suggest commonalities in microbiome disruption in patients with frCDI and mrCDI that contribute to recurrence and suggest that antibiotics followed by a live microbiome therapy may be an optimal treatment strategy for rCDI, regardless of number of prior CDI recurrences."

Journal • Infectious Disease

Budget Impact Analysis of Fecal Microbiota Spores, Live-brpk (Formerly SER-109) for Recurrent Clostridioides difficile Infection in the United States. (PubMed, Infect Dis Ther) - "Treatment with VOS is anticipated to reduce recurrences and health plan costs for those with rCDI. Using VOS earlier is expected to increase cost savings. Graphical abstract available for this article."

HEOR • Journal • Infectious Disease

Clinician Management Preferences for Clostridioides difficile Infection in Adults: A 2024 Emerging Infections Network Survey. (PubMed, Open Forum Infect Dis) - "Additionally, 72% (357/498) reported that their institutional guidelines recommended vancomycin as the first-line agent. The most common barrier to fidaxomicin use was challenges with outpatient insurance coverage (82% [408/496]). Bezlotoxumab was available to 74% (370/500) of respondents, though 33% (165/497) indicated they do not use bezlotoxumab routinely...Fecal microbiota live-jslm was available to 36% (179/500), and fecal microbiota spores live-brpk was available to 30% (150/500). Significant barriers, including high costs, insurance challenges, and limited availability of CDI therapies, impact clinical decision-making and adherence to guideline recommendations."

Journal • Infectious Disease • Transplantation

Fecal microbiota transplantation: Current evidence and future directions. (PubMed, Cleve Clin J Med) - "Product development and standardization, such as the US Food and Drug Administration-approved live biotherapeutic products Rebyota and Vowst, are helping efforts to evaluate FMT for other gastrointestinal and extraintestinal diseases. However, additional clinical trials are needed to support its use beyond recurrent C difficile infection."

Journal • Review • Infectious Disease • Transplantation

Endothelial cell iron overload and ferroptosis mediate thrombosis and inflammation through the miR-32-5p/neurofibromin 2 pathway. (PubMed, Eur J Med Res) - "Mechanism studies indicated that exosomal miR-32-5p increased in patients with TAO and could target and decrease the expression of NF2, which then decreased the phosphorylation of YAP at Ser109 and Ser217 sites. Finally, deferoxamine and Ferrostatin-1 treatment relieved the disease score, inflammation, and ferroptosis in vivo. This study newly demonstrates that iron overload and ferroptosis are key risk factors in patients with TAO and that the exosomal miR-32-5p/NF2 pathway may play an important role in TAO pathogenesis."

Journal • Cardiovascular • Hematological Disorders • Inflammation • Thrombosis • ACSL4 • NF1 • NF2 • TFRC

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

The Role of Patient-Reported Outcomes in US FDA Novel Drug Approvals and Reimbursement Decisions (2020-2024) (ISPOR 2025) - "Rinvoq (AbbVie) - PRO data showed improved quality of life in rheumatoid arthritis, contributing to $2.3 billion...Zeposia (Bristol-Myers Squibb) - PROs on fatigue reduction generated $500 million. Imcivree (Rhythm Pharmaceuticals) - PRO data supported FDA approval 2022: FDA : 37 drugs, with 30% (11 drugs) Reimbursement : 85 total approvals, with 35% (30 approvals) Adbry (LEO Pharma) - PROs on itch reduction generated $90 million . Camzyos (Bristol-Myers Squibb) - Symptom relief PROs were key 2023: FDA : 49 drugs, with 33% (16 drugs) Reimbursement 95 total approvals, with 45% (43 approvals. Leqembi (Eisai/Biogen) - FDA approval and Medicare conditional reimbursement for Alzheimer's disease leveraged PROs on cognitive function improvements, generating $200 million/ Jaypirca (Eli Lilly) - Patient-reported symptom relief supported FDA and payer decisions for mantle cell lymphoma... The inclusion of PROs in FDA novel drug approvals increased from 18% in 2020 to 40% in..."

Clinical • Patient reported outcomes • Reimbursement • US reimbursement • Alzheimer's Disease • CNS Disorders • Fatigue • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Mantle Cell Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology

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

REPEAT CLOSTRIDIOIDES DIFFICILE INFECTION AFTER ORAL FECAL MICROBIOTA SPORES COMPARED TO COLONOSCOPY-ADMINISTERED MICROBIOTA TRANSPLANT (DDW 2025) - "In 2023, the Food and Drug Administration approved a capsule-based treatment to prevent C. Diff recurrence, fecal microbiota spores live-brpk, which obviates the need for invasive endoscopic delivery and anesthesia... Our study suggests that treatment with fecal microbiota spores is effective to prevent C. Diff recurrence but may not be as potent in protecting against fulminant infection as colonoscopy FMT. Fulminant infection was more common in the spores group despite that group having fewer high-risk characteristics for recurrence. This limited study supports continued access to colonoscopy FMT and the need for more robust, long-term studies on comparative outcomes between treatments."

Anesthesia • Gastroenterology • Gastrointestinal Disorder • Hypotension • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Transplantation

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

FECAL MICROBIOTA SPORES, LIVE-BRPK (FORMERLY SER-109) IN ADULTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION IN THE UNITED STATES: ANALYSIS OF SINGLE OR REPEAT USE IN ROUTINE CLINICAL SETTINGS (DDW 2025) - "The most frequently (≥20%) prescribed antibiotics for rCDI prior to single vs repeat VOS use were vancomycin (41.6% vs 54.0%, respectively) and fidaxomicin (22.8% vs 21.6%); VOS was prescribed most frequently by gastroenterology (67.0% vs 56.8%) or infectious disease (19.7% vs 23.0%) prescribers. In the largest dataset of real-world VOS use available to date, approximately 97% of patients received VOS once to prevent recurrence of CDI after antibiotics for rCDI. These observations provide insights into VOS utilization for preventing rCDI in routine clinical settings and aim to contextualize the efficacy of VOS in clinical trials."

Clinical • Gastroenterology • Infectious Disease

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

IDENTIFICATION AND ANALYSIS OF STOOL DONORS FOR MANUFACTURING OF THE MICROBIOME THERAPEUTIC, FECAL MICROBIOTA SPORES, LIVE-BRPK, FOR THE PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION (DDW 2025) - "Robust clinical screening procedures, stool spore count assessment, donor-specific factors (ie, proximity, schedule flexibility, and donation facility access), and high rates of screen failures due to medical ineligibility resulted in a low donor eligibility rate. Understanding the impact of attrition/deferrals can help ensure VOS drug product is manufactured consistently and is of high quality. These findings may also give guidance for improving donor retention/longevity through a donor retention program."

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

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

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

Medication Use Evaluation of Fecal Microbiota Spores Livebrpk for the Prevention of Recurrent Clostridioides difficile Infection (ASHP 2024) - No abstract available

Infectious Disease