S145 Week 24 Efficacy and Safety Data from PRISM3: A Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection

Allegretti, Jessica R.; Kelly, Colleen R.; Louie, Thomas; Fisher, Monika; Hota, Susy; Misra, Bharat; Hise, Nicholas W. Van; Yen, Eugene F.; Facg,; Bullock, Jeff S.; Pullman, John; Nathan, Richard; Silverman, Michael; Davis, Ian; McGill, Sarah; Khanna, Sahil; Pardi, Darrell S.; Orenstein, Robert; Grinspan, Ari; El-Nachef, Najwa; Kraft, Colleen S.; Budree, Shrish; Borody, Thomas J.; Kassam, Zain

doi:10.14309/01.ajg.0000773052.38150.f9

Cited by 5 publications

(4 citation statements)

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“…In our review, we provide updates on three investigative strategies for the secondary prevention of CDI that focus on the restoration of the normal protective microbiome: (1) fecal microbial therapy, (2) live biotherapeutic products, and (3) probiotics, as shown in Table 3 [ 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 ].…”

Section: Resultsmentioning

confidence: 99%

“…In order to address the issue of donor stool heterogeneity in FMT, the development of known species or purified biologics has been developed. Live Biotherapeutic Products (LBP) are evaluated by the Food and Drug Administration (FDA) and several candidates have been tested in phase 2 and phase 3 RCTs ( Table 3 ) [ 85 , 86 , 87 , 88 ]. In these studies, all patients had recurrent CDI, had been treated with standard-of-care antibiotics (vancomycin, fidaxomicin, or metronidazole), and were followed for at least eight weeks for CDI recurrences.…”

Section: Resultsmentioning

confidence: 99%

“…The specific strains have not been reported. In a phase 2 study (PRISM3), 198 patients with recurrent CDI who had completed standard-of-care antibiotics were randomized to either CP101 given as a single oral capsule (6 × 10 11 /capsule) or a placebo capsule and then followed for eight weeks for recurrences of CDI [ 87 ]. Patients given CP101 not only had fewer recurrences than the placebo group (26% vs. 41%, respectively, p < 0.05), but also showed a higher alpha diversity through week eight [ 105 ].…”

Section: Resultsmentioning

confidence: 99%

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Microbiome-Related and Infection Control Approaches to Primary and Secondary Prevention of Clostridioides difficile Infections

McFarland¹,

Goldstein²,

Kullar³

2023

Microorganisms

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Clostridioides difficile infections (CDIs) have decreased in the past years, but since 2021, some hospitals have reported an increase in CDI rates. CDI remains a global concern and has been identified as an urgent threat to healthcare. Although multiple treatment options are available, prevention strategies are more limited. As CDI is an opportunistic infection that arises after the normally protective microbiome has been disrupted, preventive measures aimed at restoring the microbiome have been tested. Our aim is to update the present knowledge on these various preventive strategies published in the past five years (2018–2023) to guide clinicians and healthcare systems on how to best prevent CDI. A literature search was conducted using databases (PubMed, Google Scholar, and clinicaltrials.gov) for phase 2–3 clinical trials for the primary or secondary prevention of CDI and microbiome and probiotics. As the main factor for Clostridium difficile infections is the disruption of the normally protective intestinal microbiome, strategies aimed at restoring the microbiome seem most rational. Some strains of probiotics, the use of fecal microbial therapy, and live biotherapeutic products offer promise to fill this niche; although, more large randomized controlled trials are needed that document the shifts in the microbiome population.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Microbiome-Related and Infection Control Approaches to Primary and Secondary Prevention of Clostridioides difficile Infections

McFarland¹,

Goldstein²,

Kullar³

2023

Microorganisms

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“…Among those patients receiving a second dose of CP101 following recurrence in PRISM3, 70% (14/20) experienced 8-week treatment success and no safety concerns were noted [ 64 ]. Efficacy and safety have been reported from PRISM3 for up to 24 weeks of follow-up, with 73.5% and 59.4% ( p = 0.0347) of CP101 and placebo participants, respectively, experiencing sustained clinical cure through week 24 [ 61 ].…”

Section: Live Biotherapeutic Products (Lbps)mentioning

confidence: 99%

Emerging Options for the Prevention and Management of Clostridioides difficile Infection

Gonzales-Luna

Carlson

Garey

2023

Drugs

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Agents in development for the prevention or treatment of Clostridioides difficile infection can be split into three broad categories: antibiotics, microbiome restoration, and vaccines. Given the extensive list of agents currently in development, this narrative review will focus on agents that have progressed into late-stage clinical trials, defined as having a Phase III clinical trial registered on ClinicalTrials.gov. These agents include one antibiotic (ridinilazole), three live biotherapeutic products (LBPs) (CP101, RBX2660, and SER109), and two toxoid vaccines (PF06425090 and a second toxoid vaccine). As new prevention and treatment strategies enter the market, clinicians and administrators will need knowledge of these products to make rational decisions on how best to adopt them into clinical practice.

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Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies

Berry¹,

Khanna²

2023

BioDrugs

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S145 Week 24 Efficacy and Safety Data from PRISM3: A Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection

Cited by 5 publications

References 0 publications

Microbiome-Related and Infection Control Approaches to Primary and Secondary Prevention of Clostridioides difficile Infections

Microbiome-Related and Infection Control Approaches to Primary and Secondary Prevention of Clostridioides difficile Infections

Emerging Options for the Prevention and Management of Clostridioides difficile Infection

Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies

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