Lisa Von Moltke

Comparability of Gastrointestinal Microbiome and Bile Acid Profiles in Patients With First or Multiply Recurrent Clostridioides difficile Infection

Jessica A. M. Bryant, Timothy J. Straub, Darrell S. Pardi, Kevin D. Litcofsky et autres

BACKGROUND: Clostridioides difficile infection (CDI) treatment guidelines suggest varied approaches for patients with first (frCDI) or multiply recurrent CDI (mrCDI). Low microbial diversity, elevated primary bile acids (BA), and low secondary BA concentrations favor germination of C. difficile spores into toxin-producing bacteria …

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Exploratory analyses of immune reconstitution biomarkers from a Ph1b study of an investigational, oral, live biotherapeutic, SER-155, in adult allo-HCT.

Emily Walsh, Jonathan U. Peled, Doris M. Ponce, Satyajit Kosuri et autres

6554 Background: SER-155 is an investigational, oral, live biotherapeutic product (LBP) comprised of 16 bacterial strains designed to decolonize gastrointestinal (GI) pathogens, improve epithelial barrier integrity, and modulate immune responses to prevent bloodstream infections (BSI). In the placebo-controlled cohort 2 of the …

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Su2009: PHARMACOKINETIC (PK) AND PHARMACODYNAMIC (PD) RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED COHORT 2 OF A PHASE 1B STUDY OF AN INVESTIGATIONAL, ORAL, LIVE BIOTHERAPEUTIC, SER-155, IN ADULTS UNDERGOING ALLO-HCT

Christopher B. Ford, Jonathan U. Peled, Doris M. Ponce, Satyajit Kosuri et autres

Pharmacokinetic (PK) and Pharmacodynamic (PD) Results from a Randomized, Double-Blind, Placebo-Controlled Cohort 2 of a Phase 1b Study of an Investigational, Oral, Live Biotherapeutic, SER-155, in Adults Undergoing Allo-HCT

Jonathan U. Peled, Doris M. Ponce, Satyajit Kosuri, Nandita Khera et autres

SER-155 is an investigational, live oral biotherapeutic comprised of 16 bacterial strains, designed to prevent bloodstream infections and infection-associated events by engrafting in the gastrointestinal (GI) tract, restructuring the microbiome to reduce pathogen abundance, reducing epithelial barrier damage, and modulating inflammatory responses. …

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Safety and Efficacy Results from a Randomized, Double-Blind, Placebo-Controlled Cohort 2 of a Phase 1b Study of an Investigational Live Biotherapeutic, SER-155, in Adults Undergoing Allo-HCT

Doris M. Ponce, Satyajit Kosuri, Nandita Khera, Hemant S. Murthy et autres

Background Bloodstream infections (BSI) are common in patients undergoing allo-HCT and often arise following pathogen domination of the intestinal microbiome in the setting of GI-barrier dysfunction. SER-155 is an investigational, oral live biotherapeutic comprised of 16 bacterial strains, designed to prevent BSI …

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P-127. Safety and Efficacy of Fecal Microbiota Spores, Live-brpk (Formerly SER-109) in Patients with Recurrent Clostridioides difficile Infection (CDI): Subgroup Analysis by Number of Prior CDI Recurrences from an Integrated Analysis of Phase 3 Trials

Matthew D. Sims, Colleen S. Kraft, Edward S. Huang, Lisa Von Moltke et autres

Abstract Background Patients experiencing ≥1 recurrence of CDI are at elevated risk for subsequent recurrences and complications versus those with an initial CDI episode. Treatment selection for recurrent CDI (rCDI) is influenced by the number of recurrences a patient has experienced. Fecal …

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Correction to: Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI

Colleen S. Kraft, Matthew Sims, Michael Silverman, Thomas Louie et autres

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Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI

Colleen S. Kraft, Matthew Sims, Michael Silverman, Thomas J. Louie et autres

INTRODUCTION: Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI. OBJECTIVE, DESIGN, AND PATIENTS: To evaluate safety and efficacy of …

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Biomarkers in a phase 1b study of investigational microbiome therapeutic SER-155 in adults undergoing allogeneic hematopoietic cell transplantation (allo-HCT).

Doris M. Ponce, Swarna Pandian, Marcel R.M. van den Brink, Satyajit Kosuri et autres

6554 Background: Acute graft- versus-host disease (aGvHD) is a life-threatening complication following allo-HCT. Microbiome dysfunction and associated GI barrier disruption may contribute to aGvHD via activation of inflammatory immune responses. Circulating biomarkers in the peri-transplant period are correlated with risk of severe …

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Sa1908 SAFETY AND EFFICACY OF FECAL MICROBIOTA SPORES, LIVE-BRPK (FORMERLY SER-109) IN OLDER PATIENTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: FINDINGS FROM AN INTEGRATED ANALYSIS OF PHASE 3 TRIALS

Bret A. Lashner, Lisa Von Moltke, Ananya De, Darrell S. Pardi

Preliminary Results of the Open-Label Phase of a 2-Part Phase 1b Study That Evaluates Safety, Tolerability, Pharmacokinetics, and Efficacy of Investigational Microbiome Therapeutic SER-155 in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation (allo-HCT)

Doris M. Ponce, Satyajit Kosuri, Nandita Khera, Zachariah Michael DeFilipp et autres

In patients undergoing allo-HCT, low gastrointestinal (GI) microbial diversity is associated with adverse outcomes including bloodstream infections (BSIs) and acute graft-versus-host disease (aGvHD). SER-155 is an investigational cultivated oral microbiome therapeutic designed to engraft in the GI tract, promote GI barrier integrity, …

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S77 Safety and Efficacy of Fecal Microbiota Spores, Live-brpk (Formerly SER-109) in Older Patients With Recurrent Clostridioides difficile Infection: Findings From an Integrated Analysis of Phase 3 Trials

Bret A. Lashner, Lisa Von Moltke, Ananya De, Darrell S. Pardi

Background: Older adults are at greater risk for recurrent Clostridioides difficile infection (rCDI) than younger adults. In addition to microbiome changes associated with advanced age, risk factors may include number of comorbidities, reduced immune status, and increased antibiotic exposure. Antibiotics are necessary …

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