Novel, non-colonizing, single-strain live biotherapeutic product ADS024 protects against Clostridioides difficile infection challenge in vivo

doi:10.4291/wjgp.v14.i4.71

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Aug 24, 2023 (publication date) through Mar 5, 2026

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World Journal of Gastrointestinal Pathophysiology

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2150-5330

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Basic Study

World J Gastrointest Pathophysiol. Aug 24, 2023; 14(4): 71-85
Published online Aug 24, 2023. doi: 10.4291/wjgp.v14.i4.71

Novel, non-colonizing, single-strain live biotherapeutic product ADS024 protects against Clostridioides difficile infection challenge in vivo

Christopher K Murphy, Michelle M O’Donnell, James W Hegarty, Sarah Schulz, Colin Hill, R Paul Ross, Mary C Rea, Ronald Farquhar, Laurent Chesnel

Christopher K Murphy, Laurent Chesnel, Research and Development, Adiso Therapeutics Inc., Concord, MA 01742, United States

Michelle M O’Donnell, Sarah Schulz, Colin Hill, R Paul Ross, APC Microbiome Ireland, University College Cork, Cork T12 K8AF, Ireland

James W Hegarty, Mary C Rea, Teagasc Food Research Centre, Moorepark Fermoy, Cork P61 C996, Ireland

Ronald Farquhar, Executive Leadership Team, Adiso Therapeutics Inc., Concord, MA 01742, United States

Author contributions: Murphy CK, O’Donnell MM, Hill C, Ross RP, Rea MC, Farquhar R, and Chesnel L designed the experiments; O’Donnell MM, Hegarty JW, and Schulz S conducted the research; data was acquired and interpreted by O’Donnell MM, Hegarty JW, Schulz S, and Chesnel L; Chesnel L drafted the manuscript; all authors reviewed the manuscript and approved the final version.

Institutional animal care and use committee statement: All procedures involving animals were reviewed and approved by the Institutional Animal Care and Use Committee of NeoSome Life Sciences (IACUC Protocol No. NLS17-002).

Conflict-of-interest statement: Hill C, Ross RP, and Rea MC received consulting fees from Adiso Therapeutics, Inc. Murphy CK, Farquhar R, and Chesnel L are employees of Adiso Therapeutics, Inc. O’Donnell MM, Hegarty JW, and Schulz S are supported by an Adiso Therapeutics, Inc., research grant to UCC/APC.

Data sharing statement: No additional data are available.

ARRIVE guidelines statement: The authors have read the ARRIVE guidelines, and the manuscript was prepared and revised according to the ARRIVE guidelines.

Corresponding author: Laurent Chesnel, PhD, Research and Development, Adiso Therapeutics, Inc., 530 Virginia Road, Suite 300, Concord, MA 01742, United States. lchesnel@adisotx.com

Received: June 1, 2023
Peer-review started: June 1, 2023
First decision: July 19, 2023
Revised: August 2, 2023
Accepted: August 7, 2023
Article in press: August 7, 2023
Published online: August 24, 2023
Processing time: 83 Days and 19.8 Hours

Core Tip

Core Tip:Clostridioides difficile (C. difficile), a Gram positive pathogen associated with life-threatening gastrointestinal disease, colonizes millions of healthy people worldwide, causing disease in individuals with disrupted gut microbiomes. Here, we demonstrate in vivo efficacy of recently isolated Bacillus velezensis ADS024, without colonization, in protecting against C. difficile infection (CDI) challenge in mouse models. We also show that this novel strain has minimal effects on the gut microbiome in a human distal colon model and miniature swine. This study supports further investigation of ADS024 as a single-strain, live biotherapeutic product candidate for preventing recurrent CDI following successful standard-of-care antibiotic therapy.