Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: The BEYOND Double-Blind Randomized Clinical Trial

Previous data have shown that integrated information from single nucleotide polymorphisms (SNPs) of the host DNA, interleukin 8 (IL-8) and the enrichment of the stool microbiome can indicate the patients with infection by Clostridioides difficile (CDI) who are at risk for unfavorable outcome. This integrated information is forming the BEYOND score. The aim of the BEYOND randomized clinical trial (RCT) is to investigate if adjunctive bezlotoxumab treatment to the current standard-of-care may decrease the likelihood of unfavorable outcome for patients who score positive by the BEYOND score.

Start Date13 Apr 2022

Sponsor / Collaborator

Hellenic Institute for the Study of Sepsis

NCT05077085

/ WithdrawnPhase 4IIT

New Treatment Strategy for Patients With Multiple Recurrent Clostridioides Difficile Infection With Bezlotoxumab as First Option

The objective of this trial is to investigate whether a treatment strategy offering bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal efficacy compared with a treatment strategy with initial FMT. Strategy A includes bezlotoxumab as ancillary treatment as first option, and FMT in case of failure. Option B includes FMT as ancillary treatment as first option, and antibiotic treatment with fidaxomicin in case of failure. A secondary objective is to provide a point estimate of recurrence after bezlotoxumab for the treatment of multiple recurrent CDI.

Start Date01 Jan 2022

Sponsor / Collaborator

Leids Universitair Medisch Centrum

[+4]

NCT04626947

/ TerminatedPhase 4IIT

Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.

Start Date14 Oct 2021

Sponsor / Collaborator

University of Pittsburgh

[+1]

100 Clinical Results associated with Bezlotoxumab

100 Translational Medicine associated with Bezlotoxumab

100 Patents (Medical) associated with Bezlotoxumab

185

Literatures (Medical) associated with Bezlotoxumab

03 Apr 2026·Expert Review of Anti-Infective Therapy

Difficile to treat: advanced management strategies in difficult to treat Clostridioides difficile infections

Review

Author: Bloom, Patricia P. ; Khanna, Sahil

INTRODUCTION:

Clostridioides difficile infection (CDI) remains a leading cause of healthcare-associated infectious diarrhea, with a major burden driven by recurrences and severe or even fulminant disease in vulnerable hosts. The therapeutic landscape has shifted toward fidaxomicin-based antibiotic regimens and microbiota restoration strategies, including standardized microbiota-based products.

AREAS COVERED:

Recent international guidelines, outcome studies, and pivotal trials focused on difficult-to-treat phenotypes such as refractory or fulminant CDI, multiply recurrent CDI, and CDI in high-risk populations (immunocompromised, inflammatory bowel disease, critical illness) were reviewed. A PubMed search was supplemented by hand-searching additional references, guidelines and regulatory documents. Evidence is summarized for optimized antibiotic regimens, bezlotoxumab, conventional fecal microbiota transplantation (FMT), FDA-approved microbiota-based products, and salvage strategies including intracolonic therapy and surgery.

EXPERT OPINION:

Advanced CDI management is moving from repeated antibiotic cycling toward individualized recurrence prevention and microbiota restoration strategies. Implementation requires diagnostic stewardship, early recognition of recurrences, clear pathways for microbiota-based therapy access, and multidisciplinary care for fulminant infection. Over the next five years, standardized microbiota therapeutics and better risk tools should shift care toward earlier, more durable recurrence prevention.

17 Jan 2026·Journal of the Pediatric Infectious Diseases Society

Pediatric Infectious Diseases Physicians’ Preferences for Management of Clostridioides difficile Infection: An Emerging Infections Network Survey

Article

Author: Sandora, Thomas J ; Linn, Alexandra ; Lee, Matthew S L ; Boton, Noah ; Polgreen, Philip M ; Kociolek, Larry ; Beekmann, Susan E ; Mehrotra, Preeti

Abstract:

We queried pediatric infectious diseases physicians via the Emerging Infections Network regarding management preferences for Clostridioides difficile infection (CDI). We explored use of vancomycin, fidaxomicin, bezlotoxumab, and fecal microbiota transplantation and found that physicians are increasingly considering newer and adjunctive therapies for pediatric CDI, highlighting the need for updated guidelines.

01 Jan 2026·Cell Reports Medicine

A randomized controlled trial of precision bezlotoxumab treatment for Clostridioides difficile infection

Article

Author: Metallidis, Symeon ; Milionis, Haralarampos ; Giamarellos-Bourboulis, Evangelos J ; Netea, Mihai G ; Toutouzas, Konstantinos ; Tasouli, Elisavet ; Bolanou, Amalia ; Lada, Malvina ; Poulakou, Garyfallia ; Adamis, Georgios ; Hatziagelaki, Erifli ; Kumar, Vinod ; Iliopoulou, Konstantina ; Psarrakis, Christos ; Symbardi, Styliani ; Tziolos, Nikolaos-Renatos ; Sidiropoulou, Chrysanthi ; Skoutelis, Athanasios ; Stylianakis, Emmanouil ; Akinosoglou, Karolina ; Kostaki, Alina ; Matzarakis, Vicky ; Chrysos, George ; Samarkos, Michael ; Panagopoulos, Periklis ; Alexiou, Zoi ; Georgiadou, Sarah

Early risk recognition for organ dysfunction and death by Clostridioides difficile infection (CDI) is an unmet need. A prediction score is developed in the BEYOND study (ClinicalTrials.gov; NCT02573571, NCT04725123, and NCT05304715). At the first stage, using 153 patients and 150 comparators, the BEYOND score was developed integrating hemoglobin; blood urea; blood interleukin-8; carriage of G alleles of rs2091172; and presence of Terrisporobacter glycolicus, Enterococcus avium, and Anaerovorax odorimutans in the stool. The score had 84.6% sensitivity and 95.8% specificity for unfavorable outcomes. At the second stage, a double-blind randomized controlled trial was performed, and 44 patients at high-risk by BEYOND score were treated with standard-of-care plus Bezlotoxumab or placebo. The primary endpoint was the incidence of organ dysfunction, CDI relapse, and/or death. This endpoint was met in 72.7% of patients in the placebo arm and 31.8% in the Bezlotoxumab arm (p = 0.015). Results suggest that BEYOND score can detect early risk in patients with CDI.

News (Medical) associated with Bezlotoxumab

05 May 2026

·www.biospace.com

Sail Biomedicines Appoints Gene Marcantonio, M.D., Ph.D., as Chief Medical Officer

Appointment strengthens clinical leadership team as Sail advances its lead In Vivo eRNA™-TNP CAR-T program for autoimmune diseases toward the clinic CAMBRIDGE, Mass.--(BUSINESS WIRE)-- #CARTtherapy --Sail Biomedicines, a Flagship Pioneering company, today announced the appointment of Dr. Gene Marcantonio as Chief Medical Officer. Dr. Marcantonio brings deep experience spanning translational medicine, early clinical development, immunology, and therapeutic strategy. Across leadership roles in biotech, large pharma, and academic medicine, he has guided multiple immunology-based programs from early development into the clinic, including oversight of successful Investigational New Drug (IND) applications, Phase 1 studies, and Phase 2 development across a range of therapeutic areas. “Dr. Marcantonio brings clinical judgement, translational experience, and development leadership needed for the early clinical development for our in vivo CAR-T programs,” said John Mendlein, Ph.D., Executive Chairman and Co-founder of Sail Biomedicines and Executive Partner at Flagship Pioneering. “We believe our vanguard in vivo CAR-T product candidate has the potential to deliver the depth of B-cell depletion and immune reset needed for curative treatment approaches in autoimmune diseases.” At Sail, Dr. Marcantonio will lead clinical strategy and development across the company’s pipeline, with an initial focus on advancing the vanguard in vivo eRNA-TNP CAR-T program for autoimmune diseases. His appointment reflects the company’s focus on the execution of the clinical development strategy. “Autoimmune diseases continue to represent a major unmet medical need, and many people still cycle through chronic therapies without achieving durable control of their disease,” said Dr. Marcantonio. “What is compelling about Sail’s approach is the possibility of delivering a fundamentally different therapeutic effect, a potentially curative treatment built around deep B-cell depletion and immune reset that could have meaningful impact across multiple autoimmune diseases. I’m excited to help shape the development strategy for that opportunity.” Before joining Sail, Dr. Marcantonio was Associate Vice President in Translational Pharmacology at Merck, where he led early-stage development efforts across infectious diseases, vaccines, and immunology and contributed to the development and approval of several therapeutics, including GRASTEK®, RAGWITEK®, NOXAFIL®, UBRELVY™, PREVYMIS®, ASMANEX® HFA, ZEPATIER™, ZINPLAVA™, and ENFLONSIA™. From Merck, Dr. Marcantonio served as CEO and Chief Medical Officer of ARMGO Pharma, now Rycarma Therapeutics, where he oversaw three INDs, a Phase 1b study at the NIH, a Phase 2 study in CPVT, and three Phase 1 studies. Earlier in his career, he was a tenured faculty member at Columbia University’s College of Physicians & Surgeons in the Department of Pathology and Cell Biology and an attending pathologist at NewYork-Presbyterian Hospital. About Sail Biomedicines Sail Biomedicines is pioneering AI-driven design and deployment of fully programmable RNA medicines to transform patient care. Sail’s platform combines eRNA™ constructs, a first-in-class programmable circular RNA product form, and an industry-leading platform of targeted nanoparticles to unlock comprehensive programming of medicines for the first time. Using its cutting-edge eRNA and nanoparticle deployment platform, Sail is building a pipeline of In Vivo CAR-T based products. Sail was founded by Flagship Pioneering. For more, visit and follow us on X ( @SailBiomeds ) and LinkedIn . Contacts press@sail.bio

Executive ChangePhase 1ImmunotherapyPhase 2

03 Apr 2026

·allsci.com

Data committee gives nod for Vedanta’s VE303 to advance in Phase III for C. difficile infection prevention

Vedanta Biosciences reported that an independent data monitoring committee has recommended the Phase III RESTORATiVE303 trial of VE303 continue without modification following a prespecified interim analysis, with the DMC determining that efficacy exceeded the futility threshold and no new safety signals had emerged. RESTORATiVE303 is a randomized, double-blind, placebo-controlled, multinational Phase III trial enrolling patients at high risk for recurrent Clostridioides difficile infection (CDI) across more than 150 sites in approximately 20 countries, with participants randomized 2:1 to a 14-day course of VE303 or placebo. The interim analysis was triggered when 50% of planned enrollees had reached the Week 8 primary efficacy timepoint, which is the CDI recurrence rate at that mark. No numerical efficacy or safety data were disclosed; the DMC’s mandate in a blinded trial is limited to assessing whether accumulating data fall within prespecified statistical boundaries, and a continuation recommendation indicates the trial retains adequate power to detect the primary endpoint at protocol-defined sample size. The DMC reported no significant adverse events or new safety signals. Vedanta anticipates completing enrollment in the second half of 2026, with a second interim analysis also planned for that period. VE303 is a live biotherapeutic product consisting of a defined consortium of eight bacterial strains produced from pure, clonal cell banks — a manufacturing approach that bypasses donor fecal material entirely. In the Phase II CONSORTiUM study, high-dose VE303 achieved a 30.5% adjusted absolute risk reduction in CDI recurrence versus placebo, corresponding to a greater than 80% reduction in the odds of recurrence. The Phase III trial is intended to support a Biologics License Application to the FDA. VE303 holds Orphan Drug Designation (2017) and Fast Track Designation (2023). The recurrent CDI prevention space now contains two FDA-approved microbiome-based live biotherapeutics: Vowst (fecal microbiota spores, live-brpk), approved in April 2023, and Rebyota (fecal microbiota, live-jslm), approved in November 2022. Both are donor-derived products — Vowst administered orally and Rebyota rectally — and both demonstrated reduced recurrence versus placebo in their pivotal trials. VE303’s defined, non-donor-derived composition is its primary structural distinction from these approved competitors. Cross-trial comparisons are limited by differences in patient populations, prior CDI episode counts, qualifying antibiotic regimens, and endpoint definitions, so Phase II data for VE303 cannot be directly benchmarked against pivotal data for Vowst or Rebyota. The CDI market also includes bezlotoxumab (Zinplava), a monoclonal antibody that neutralizes C. difficile toxin B and is administered as a single IV infusion adjunct during antibiotic therapy, and fidaxomicin (Dificid), the narrow-spectrum antibiotic that is guideline-preferred for recurrent CDI treatment and is itself part of the standard-of-care backdrop in RESTORATiVE303 — the trial enrolls a proportion of patients receiving fidaxomicin for their qualifying CDI episode. VE303 is positioned as a post-antibiotic microbiome restoration agent, complementary to rather than competitive with antibiotic treatment. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultPhase 3Orphan DrugPhase 2Fast Track

20 Nov 2025

·endpoints.news

Pentagon-backed Lumen is ready to drastically slash antibody manufacturing costs

Seattle-based Lumen Bioscience co-founder and CEO Brian Finrow doesn’t want to just bring down the cost of manufacturing antibodies. He wants to cut it to a tiny fraction of the current price, and allow the commonly infused or injected treatments to be ingested as pills. Finrow and his team of about 100 employees are working on a new way to manufacture proteins in an edible blue-green algae called spirulina, rather than in typical E. coli or Chinese hamster ovary cells. The Defense Department is currently funding the company’s first Phase 3 trial, of a therapeutic made in spirulina. The study, with results expected in June, is focused on a treatment for C. difficile infections. It’s based on an older Merck drug called Zinplava. Finrow told Endpoints News in an interview that Zinplava was expensive to make and difficult to administer because it required a PICC line, a type of long catheter. Merck discontinued it for financial reasons. Unlike Zinplava, Lumen’s experimental treatment, known as LMN-201, can be ingested. Whereas the cost of manufacturing one gram of antibody is about $100 to $200 for a biopharma company, Lumen can currently bring that price down to about 10 cents — and it wants to go even cheaper, Finrow said. “It’s a biologic basically with the scalability and the cost profile of a small molecule drug,” Finrow said. He also noted the safety risks of ingesting antibodies is much lower than injecting them, particularly since there aren’t sterility concerns with spirulina, which has attracted attention from the Defense Department and the Gates Foundation. Lumen has yet to show its techniques can be scaled large enough to enable a commercial rollout. But Finrow said the protein yields in spirulina are higher and more dense than what’s seen under current standard processes. “It’s super cheap, massively scalable for us to make this product under GMP,” he said. The company is also working on a Phase 2 trial in Australia for a weight loss drug that was initially developed by Novo Nordisk. The plan was to work on the therapy with Novo, and have them develop it in the clinic. But after receiving initial funding from Novo to start the development, Finrow said, “everyone we knew there got fired.” After the organizational changes, Lumen has taken over. “We had to pick it up internally, not because the data was bad but it was just chaos over there,” Finrow said. “They have never owned the IP. We’re hoping to upcharge them. The data look good.” Finrow conceded that Lumen’s oral weight loss drug, known as LMN-801, likely won’t compete with Eli Lilly’s megablockbuster GLP-1 tirzepatide, but it could supplement it. “We don’t need to do better than tirzepatide. People can lose all the weight on tirzepatide and then switch to a nice convenient, oral, cheap, daily maintenance drug. And in that sense, we don’t even need to show weight loss induction. We just need to prevent weight regain,” he said. “The data we have to date, which includes a bit of human data, also indicate that our products should be additive or synergistic with the existing GLP-1 and amylin products, which would open up that tantalizing possibility,” Finrow added. With more than $185 million invested into his platform to date, the company has two manufacturing facilities and several other development programs in the works, but will need to scale up dramatically or partner with a larger company to commercialize its products.

Phase 3

100 Deals associated with Bezlotoxumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10453	Bezlotoxumab	J06BB21	DB13140

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Clostridium Infections	Japan	Merck Sharp & Dohme Corp.	27 Sep 2017
Diarrhea	Japan	Merck Sharp & Dohme Corp.	27 Sep 2017
Clostridium difficile infection	United States	Merck Sharp & Dohme LLC	21 Oct 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04626947 (CTgov)	Phase 4	Crohn Disease \| Colitis, Ulcerative \| Clostridium difficile infection	19	Bezlotuxumab	khwkctmizt = kfvxesvfhh ceeccjskaa (dzxoffymgn, qixesrvesg - uklfoykole) View more	-	05 Jun 2025
NCT03829475 (ICON-2, CTgov)	Phase 2	Crohn Disease \| Inflammatory Bowel Diseases \| Colitis, Ulcerative ... View more	61	Fecal Microbiota Transplantation+Bezlotoxumab (FMT + Bezlo)	tcrrofhryr = gqdlcgdcxk atbunqvsds (nhlgpwkyop, zxgajajmcr - btiahktchc) View more	-	11 Dec 2024
				Fecal Microbiota Transplantation (FMT + Placebo)	tcrrofhryr = pwruggphnm atbunqvsds (nhlgpwkyop, iabwsnjehv - mpcxiyvjbu) View more
NCT03182907 (MODIFY III, Pubmed \| J Pediatric Infect Dis Soc)	Phase 3	Clostridium difficile infection	148	Bezlotoxumab 10 mg/kg	rfqcnvmmnc(pponybpazi) = wpdllhcjvu phrzsdjbsb (guabdhmxnf, 0.95 - 1.18)	Positive	30 Jun 2023
				Placebo	rfqcnvmmnc(pponybpazi) = hwoyavqesu phrzsdjbsb (guabdhmxnf, 0.75 - 0.89)
NCT03182907 (6072-001 \| MODIFY III \| MK-6072-001, CTgov)	Phase 3	Clostridium difficile infection	148	Antibacterial drug treatment (ABD)+Bezlotoxumab (Bezlotoxumab)	qqfcafhslt = uishneolgb nwylmlxbyv (nnnfscijcc, ggldrfvicl - qrwuqjpafg) View more	-	07 Jun 2023
				Placebo (Placebo)	qqfcafhslt = zjlwagsdtq nwylmlxbyv (nnnfscijcc, xalhsbrfrp - fumuggygjc) View more
DDW2023	Not Applicable	Clostridioides difficile infection recurrence	-	Bezlotoxumab	xzjaikeofx(dsezzyiiyp) = zsxxeetlgz wllmwrccik (qqledreeiv, 372 - 3600) View more	-	07 May 2023
DDW2023	Not Applicable	Heart Failure	-	Bezlotoxumab	jqtachmabe(nuqsojyqpi) = mild tongue swelling, prutitus and headache that required monitoring for less that 24 hours; this patient had HFpEF bfrxwzyicm (bpaskskmhs )	-	07 May 2023
				Placebo
NCT03937999 (CTgov)	Phase 4	Clostridium Infections \| Clostridium difficile infection	1	Bezlotoxumab (Bezlotoxumab Arm)	pjgulhsrup(aivkhltnxv) = vadkrviaoz xcemqutqsb (xgzidfzqhw, sampadrwxj - wzqxukitrl) View more	-	09 Nov 2022
				Bezlotoxumab (No Bezlotoxumab)	njoofuzljr = aaznfwbvrc imvwscnytj (asogninbzw, cvhdhhtcen - bzxnfhecrj) View more
UEGW2022	Not Applicable	-	53	Bezlotoxumab	crzmsybszh(azltmwiadr) = No patient had adverse events related to bezlotoxumab vbomnajjod (gwxkwftwvm ) View more	Negative	09 Oct 2022
NCT01513239 \| NCT01241552 (Pubmed \| Anaerobe)	Phase 3	Clostridium difficile infection	259	Bezlotoxumab	zqdzfzkiqo(dubuvzgcfy) = yknemmnudh iufnklmxor (zbizdeevzd )	-	01 Feb 2020
				No bezlotoxumab	zqdzfzkiqo(dubuvzgcfy) = pjqkhfhaef iufnklmxor (zbizdeevzd )
NCT01513239 \| NCT01241552 (MODIFY I/II, Pubmed \| Open Forum Infect Dis)	Phase 3	Neoplasms	1,554	Bezlotoxumab	dkdjybqbgu(kobgqqomqi): absolute difference = -12.6 (95% CI, -22.5 to -2.7)	-	01 Feb 2020
				Placebo

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