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Your search keyword '"Lombardo, Mary-Jane"' showing total 16 results
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16 results on '"Lombardo, Mary-Jane"'

1. 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)

Author

Ponce, Doris M., primary, Kosuri, Satyajit, additional, Khera, Nandita, additional, DeFilipp, Zachariah, additional, Lichter, David, additional, Lombardo, Mary-Jane, additional, Peled, Jonathan U., additional, van den Brink, Marcel R.M., additional, Chafee, Meghan, additional, Wortman, Jennifer R, additional, Straub, Timothy, additional, Walsh, Emily, additional, Ge, Augustus, additional, Lyttle, David, additional, Brady, Kelly, additional, Puhl, Matthew D, additional, Glick, Gabrielle, additional, Hasson, Brooke R, additional, Tejura, Bina, additional, Ford, Christopher B, additional, Henn, Matthew R, additional, and von Moltke, Lisa, additional

Published
2024
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2. Impact of a Purified Microbiome Therapeutic on Abundance of Antimicrobial Resistance Genes in Patients With Recurrent Clostridioides difficile Infection.

Author

Straub, Timothy J, Lombardo, Mary-Jane, Bryant, Jessica A, Diao, Liyang, Lodise, Thomas P, Freedberg, Daniel E, Wortman, Jennifer R, Litcofsky, Kevin D, Hasson, Brooke R, McGovern, Barbara H, Ford, Christopher B, and Henn, Matthew R

Subjects
*RESEARCH funding, *DRUG resistance in microorganisms, *CLOSTRIDIOIDES difficile, *STATISTICAL sampling, *HUMAN microbiota, *RANDOMIZED controlled trials
Abstract

Background The gastrointestinal microbiota is an important line of defense against colonization with antimicrobial resistant (AR) bacteria. In this post hoc analysis of the phase 3 ECOSPOR III trial, we assessed impact of a microbiota-based oral therapeutic (fecal microbiota spores, live; VOWST Oral Spores [VOS], formerly SER-109]; Seres Therapeutics) compared with placebo, on AR gene (ARG) abundance in patients with recurrent Clostridioides difficile infection (rCDI). Methods Adults with rCDI were randomized to receive VOS or placebo orally for 3 days following standard-of-care antibiotics. ARG and taxonomic profiles were generated using whole metagenomic sequencing of stool at baseline and weeks 1, 2, 8, and 24 posttreatment. Results Baseline (n = 151) and serial posttreatment stool samples collected through 24 weeks (total N = 472) from 182 patients (59.9% female; mean age: 65.5 years) in ECOSPOR III as well as 68 stool samples obtained at a single time point from a healthy cohort were analyzed. Baseline ARG abundance was similar between arms and significantly elevated versus the healthy cohort. By week 1, there was a greater decline in ARG abundance in VOS versus placebo (P =.003) in association with marked decline of Proteobacteria and repletion of spore-forming Firmicutes, as compared with baseline. We observed abundance of Proteobacteria and non–spore-forming Firmicutes were associated with ARG abundance, while spore-forming Firmicutes abundance was negatively associated. Conclusions This proof-of-concept analysis suggests that microbiome remodeling with Firmicutes spores may be a potential novel approach to reduce ARG colonization in the gastrointestinal tract. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Impact of a Purified Microbiome Therapeutic on Abundance of Antimicrobial Resistance Genes in Patients With Recurrent Clostridioides difficile Infection

Author

Straub, Timothy J, primary, Lombardo, Mary-Jane, additional, Bryant, Jessica A, additional, Diao, Liyang, additional, Lodise, Thomas P, additional, Freedberg, Daniel E, additional, Wortman, Jennifer R, additional, Litcofsky, Kevin D, additional, Hasson, Brooke R, additional, McGovern, Barbara H, additional, Ford, Christopher B, additional, and Henn, Matthew R, additional

Published
2023
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4. Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool

Author

McChalicher, Christopher W J, primary, Lombardo, Mary-Jane, additional, Khanna, Sahil, additional, McKenzie, Gregory J, additional, Halvorsen, Elizabeth M, additional, Almomani, Sanabel, additional, Schuster, Brian, additional, Hasson, Brooke R, additional, McGovern, Barbara H, additional, Ege, David S, additional, and Auniņš, John G, additional

Published
2023
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5. Manufacturing Process of Investigational Microbiome Therapeutic, SER-109, Reduces Risk of Bacterial Pathogen Transmission

Author

McChalicher, Christopher W.J., primary, Lombardo, Mary-Jane, additional, Khanna, Sahil, additional, McKenzie, Gregory J., additional, McGovern, Barbara H., additional, Auniņš, John G., additional, Halvorsen, Elizabeth M., additional, Almomani, Sanabel, additional, Schuster, Brian, additional, and Ege, David S., additional

Published
2023
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6. A Phase 1b Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of an Investigational Microbiome Therapeutic, SER-155, in Adults Undergoing Hematopoietic Stem Cell Transplantation

Author

Ponce, Doris M, primary, Peled, Jonathan U, additional, Tejura, Bindu, additional, Ford, Christopher, additional, van den Brink, Marcel R M, additional, Lombardo, Mary Jane, additional, Kosuri, Satyajit, additional, Khera, Nandita, additional, Defilipp, Zachariah, additional, and von Moltke, Lisa, additional

Published
2022
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10. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection

Author

Feuerstadt, Paul, primary, Louie, Thomas J., additional, Lashner, Bret, additional, Wang, Elaine E.L., additional, Diao, Liyang, additional, Bryant, Jessica A., additional, Sims, Matthew, additional, Kraft, Colleen S., additional, Cohen, Stuart H., additional, Berenson, Charles S., additional, Korman, Louis Y., additional, Ford, Christopher B., additional, Litcofsky, Kevin D., additional, Lombardo, Mary-Jane, additional, Wortman, Jennifer R., additional, Wu, Henry, additional, Auniņš, John G., additional, McChalicher, Christopher W.J., additional, Winkler, Jonathan A., additional, McGovern, Barbara H., additional, Trucksis, Michele, additional, Henn, Matthew R., additional, and von Moltke, Lisa, additional

Published
2022
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11. 1035. Manufacturing Processes of SER-109, a Purified Investigational Microbiome Therapeutic, Reduce Risk of Transmission of Emerging and Undetected Infections in Donor Stool

Author

McChalicher, Christopher, primary, Abdulaziz, Ahmad, additional, Halvorsen, Elizabeth, additional, Lombardo, Mary-Jane, additional, Winkler, Jonathan, additional, Almomani, Sanabel, additional, McGovern, Barbara, additional, McKenzie, Gregory, additional, Ege, David, additional, and Aunins, John, additional

Published
2021
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13. LB15. SER-109, an Investigational Microbiome Therapeutic, Reduces Abundance of Antimicrobial Resistance Genes in Patients with Recurrent Clostridioides difficile Infection (rCDI) after Standard-of-Care Antibiotics

Author

Straub, Timothy J, primary, Diao, Liyang, additional, Ford, Christopher, additional, Sims, Matthew, additional, Louie, Thomas J, additional, Berenson, Charles, additional, Kraft, Colleen S, additional, Cohen, Stuart H, additional, Paskovaty, Alla, additional, Lombardo, Mary-Jane, additional, McGovern, Barbara, additional, von Moltke, Lisa, additional, and Henn, Matt, additional

Published
2021
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14. Impact of Investigational Microbiome Therapeutic SER-155 on Pathogen Domination: Initial Results from a Phase 1b Study in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT)

Author

Peled, Jonathan U., van den Brink, Marcel R.M., Ponce, Doris M., Kosuri, Satyajit, Khera, Nandita, DeFilipp, Zachariah, Tejura, Bina, Lichter, David I, Lombardo, Mary-Jane, Chafee, Meghan, Wortman, Jennifer R, Straub, Timothy, Walsh, Emily, Ge, Augustus, Lyttle, David, Hasson, Brooke, Ford, Christopher, von Moltke, Lisa, and Henn, Matthew

Published
2023
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16. SER-109, an Oral Microbiome Therapy for Recurrent Infection.

Author

Feuerstadt, Paul, Louie, Thomas J., Lashner, Bret, Wang, Elaine E. L., Diao, Liyang, Bryant, Jessica A., Sims, Matthew, Kraft, Colleen S., Cohen, Stuart H., Berenson, Charles S., Korman, Louis Y., Ford, Christopher B., Litcofsky, Kevin D., Lombardo, Mary-Jane, Wortman, Jennifer R., Wu, Henry, Auninš, John G., McChalicher, Christopher W. J., Winkler, Jonathan A., and McGovern, Barbara H.

Abstract

Background: Current therapies for recurrent Clostridioides difficile infection do not address the disrupted microbiome, which supports C. difficile spore germination into toxin-producing bacteria. SER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores for the treatment of recurrent C. difficile infection.Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial in which patients who had had three or more episodes of C. difficile infection (inclusive of the qualifying acute episode) received SER-109 or placebo (four capsules daily for 3 days) after standard-of-care antibiotic treatment. The primary efficacy objective was to show superiority of SER-109 as compared with placebo in reducing the risk of C. difficile infection recurrence up to 8 weeks after treatment. Diagnosis by toxin testing was performed at trial entry, and randomization was stratified according to age and antibiotic agent received. Analyses of safety, microbiome engraftment, and metabolites were also performed.Results: Among the 281 patients screened, 182 were enrolled. The percentage of patients with recurrence of C. difficile infection was 12% in the SER-109 group and 40% in the placebo group (relative risk, 0.32; 95% confidence interval [CI], 0.18 to 0.58; P<0.001 for a relative risk of <1.0; P<0.001 for a relative risk of <0.833). SER-109 led to less frequent recurrence than placebo in analyses stratified according to age stratum (relative risk, 0.24 [95% CI, 0.07 to 0.78] for patients <65 years of age and 0.36 [95% CI, 0.18 to 0.72] for those ≥65 years) and antibiotic received (relative risk, 0.41 [95% CI, 0.22 to 0.79] with vancomycin and 0.09 [95% CI, 0.01 to 0.63] with fidaxomicin). Most adverse events were mild to moderate and were gastrointestinal in nature, with similar numbers in the two groups. SER-109 dose species were detected as early as week 1 and were associated with bile-acid profiles that are known to inhibit C. difficile spore germination.Conclusions: In patients with symptom resolution of C. difficile infection after treatment with standard-of-care antibiotics, oral administration of SER-109 was superior to placebo in reducing the risk of recurrent infection. The observed safety profile of SER-109 was similar to that of placebo. (Funded by Seres Therapeutics; ECOSPOR III ClinicalTrials.gov number, NCT03183128.). [ABSTRACT FROM AUTHOR]

Published
2022
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