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

Angiotensin 1-7 Modulates the Dynamics and Activation of the Proto-Oncogene Mas Receptor. (PubMed, J Mol Recognit) - "We demonstrate that Ang 1-7 releases the inactive core lock (ARG245-TYR248) to engage a critical anchor cluster (SER109/PHE112)...These findings provide a structural rationale for the partial agonist profile of Ang 1-7 and offer a transformative mechanistic framework for therapeutic targeting of the ACE2/Ang 1-7/MasR axis. We propose that rational drug design need not aim for maximal receptor opening; instead, strategies focusing on peptidomimetics or positive allosteric modulators (PAMs) that stabilize this specific compact active state could selectively potentiate protective RAS signaling."

Journal • Oncology • ANGPT1

Structural properties of antioxidant peptides released from sweet apricot kernel protein with regulation by ultrasound-assisted enzymolysis. (PubMed, Ultrason Sonochem) - "Molecular docking simulation indicates that the differential active pockets of Alcalase, Flavourzyme, Neutrase and Papain in traditional enzymolysis are Asp30-Gly102-Pro108-Ser109-Ser116-Tyr119-Gly131-Thr139-Asn144-Arg150-Lys151-Asn152-Asp153-Glu163-Asn166-Lys281-Ser324-Ser326-Pro425-Thr427, Gln91-Lys99-Ser248-Lys255-Val285-Glu287-Ala299-Cys301-Tyr325-Asn337-Gln359-Arg362, Ser49-Tyr107-Ser119-Val140-Asn152-Tyr194-Lys220-Arg221-Asn228 and Gly23-Arg111-Gln128-Asn155-Tyr208-Pro209 residues, respectively. Similarly, the correspondingly differential active pockets for ultrasound-assisted enzymolysis are Gly164-Ala172-Tyr195-Phe240-Asn383-Arg396, BMA3-Man4-Asp27-Tyr29-Glu43-Lys54-Glu61-Lys118-Ser153-Asp183-Ser186-Asp286-Asp298-Thr302-Thr305-Asp307-Ser339-Asp346, Glu167-Ser223 and Asp6-Gly20-Gys22-Arg58-Gln92-Gln114-Ala126-Lys156 residues, respectively. As a result, this investigation proves that ultrasound selectively increases cleavage sites of enzymolysis and the targeted..."

Journal • PLK4

Emerging Therapeutic Approaches for Modulating the Intestinal Microbiota. (PubMed, Pharmaceutics) - "BCT offers a standardized alternative to donor-derived material, with early clinical successes such as FDA-approved SER-109. Phage therapy and OMVs represent promising frontiers, offering targeted microbial modulation and interactions with the immune system, although clinical data remain limited. Emerging gut microbiota modulation strategies offer new perspectives for precision medicine and could transform the prevention and treatment of many diseases, but further studies are needed to ensure their safety, standardization, and clinical application."

Journal • Review • Cardiovascular • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Mental Retardation • Obesity • Psychiatry • Transplantation

Clinical applications of live biotherapeutics: Current trends and future prospects. (PubMed, Prog Mol Biol Transl Sci) - "The most important advancement is in the infectious disease domain, where fecal microbiota transplantation validated ecological restoration for recurrent Clostridioides difficile infection and paved the way for the first approved LBPs (REBYOTA® and VOWST™/SER-109). Translation from benchside to bedside, however, is fraught with hurdles-variable patient response, manufacturing consistency, safety standards, cost, and ethics-exacerbated by heterogeneous global regulations, underscoring the need for harmonization. Precision microbial consortia, programmable "living medicines," and biohybrid formulations could extend LBPs into broader indications and global health, shifting practice toward an ecological model of therapeutics."

Journal • Review • Allergy • Immunology • Infectious Disease • Metabolic Disorders • Oncology • Transplantation

Live biotherapeutics in the clinic: Regulatory pathways, market dynamics, and future trends. (PubMed, Prog Mol Biol Transl Sci) - "The approvals of Rebyota and Vowst for recurrent Clostridioides difficile infection mark a pivotal milestone, establishing LBPs as a new therapeutic class. Progress, however, is tempered by manufacturing complexity, regulatory burden, reimbursement challenges, public perception, and incomplete mechanistic understanding. Despite these hurdles, the future is compelling, marked by expanding indications, engineered strains, standardized consortia, scalable manufacturing, regulatory harmonization, and accelerating investment."

Journal • Review • Infectious Disease • Metabolic Disorders • Oncology

Fecal Microbiota Transplantation in 2025: Two Steps Forward, One Step Back. (PubMed, Curr Gastroenterol Rep) - "After decades of steady progress, the U.S. Food and Drug Administration (FDA) approved the first FMT-based therapies: fecal microbiota, live-jslm and fecal microbiota spores, live-brpk-in 2022 and 2023, respectively. Although first reported almost seventy years ago, extensive efforts over the last two decades have placed FMT in routine algorithms for many patients with CDI. While understanding of the intestinal microbiome's role in other gastrointestinal conditions is expanding, and FMT may modulate these pathways, additional evidence is needed before FMT becomes routine outside CDI."

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

The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome. (PubMed, Nat Med) - P2, P3 | "VOWST (VOWST oral spores, VOS; fecal microbiota spores, live-brpk, formerly SER-109) is an FDA-approved, orally administered consortium of purified Firmicutes spores developed to prevent recurrent Clostridioides difficile infection (CDI)...These findings on the pharmacology of VOS underscore the importance of rapidly restoring key protective functions of the microbiome in patients with recurrent CDI to achieve durable prevention of recurrence, as observed in the phase 3 study; they also highlight the need to include the microbiome in the clinical management of CDI. ClinicalTrials.gov registrations: NCT02437487 and NCT03183128 ."

Journal • Infectious Disease

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