P421 SER-287, an investigational microbiome therapeutic, induces remission and endoscopic improvement in a placebo-controlled, double-blind randomised trial in patients with active mild-to-moderate ulcerative colitis

Misra, Bharat; Curran, John; Herfarth, Hans H; Jagarlamudi, Kuppuswamy; Oneto, Caterina; Bhandari, Bal R.; Wiener, Gregory; Kerman, David H.; Moss, Alan C.; Pomerantz, Roger J.; Zhao, Jinfang; Bernardo, Patricia; Simmons, Stephanie; Diao, Liyang; O’Brien, E.; Henn, Matthew R.; Trucksis, Michele

doi:10.1093/ecco-jcc/jjx180.548

Cited by 5 publications

(5 citation statements)

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“…A phase IIb clinical trial with an estimated enrolment of 201 patients with ulcerative colitis is currently underway using SER-287 (Seres Therapeutics), a capsule containing spores that are derived from members of the Firmicutes phylum, with or without vancomycin pretreatment (NCT03759041) 166 . This trial is based on promising results from a phase Ib trial on induction of remission in ulcerative colitis 167 . Another consortia-based therapy, VE202 (Vedanta Biosciences in conjunction with Janssen Biotech), which uses a rationally defined selection of regulatory T cellinducing bacteria that have known butyrate-producing activity 4 , is due to enter a phase I trial 168 .…”

Section: Therapeutic Optionsmentioning

confidence: 99%

Gut microbiota-derived metabolites as key actors in inflammatory bowel disease

Lavelle

Sokol

2020

Nat Rev Gastroenterol Hepatol

1,116

822

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A key role of the gut microbiota in the establishment and maintenance of health, as well as in the pathogenesis of disease, has been identified over the past two decades. One of the primary modes by which the gut microbiota interacts with the host is by means of metabolites, which are small molecules that are produced as intermediate or end products of microbial metabolism. These metabolites can derive from bacterial metabolism of dietary substrates, modification of host molecules, such as bile acids, or directly from bacteria. Signals from microbial metabolites influence immune maturation, immune homeostasis, host energy metabolism and maintenance of mucosal integrity. Alterations in the composition and function of the microbiota have been described in many studies on IBD. Alterations have also been described in the metabolite profiles of patients with IBD. Furthermore, specific classes of metabolites, notably bile acids, short-chain fatty acids and tryptophan metabolites, have been implicated in the pathogenesis of IBD. This Review aims to define the key classes of microbial-derived metabolites that are altered in IBD, describe the pathophysiological basis of these associations and identify future targets for precision therapeutic modulation.

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Section: Therapeutic Optionsmentioning

confidence: 99%

Gut microbiota-derived metabolites as key actors in inflammatory bowel disease

Lavelle

Sokol

2020

Nat Rev Gastroenterol Hepatol

1,116

822

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“…This consortium combination was revealed using a top‐down gnotobiotic method, which involved transferring human‐derived fecal microbiota into germ‐free mice after chloroform therapies (which eliminates all but spores), followed by subsequent mouse‐to‐mouse transfers while choosing for the particular anti‐inflammatory Treg development 45 . In conjunction with Vedanta, Seres Therapeutics promotes the development of SER‐287, a consortium of several Firmicutes spores which has been evaluated in a phase 2 study 223 . SER‐301, a more contemporary LBP that has reached phase 1 trials, consists of a collection of 18 live human commensal bacterial strains isolated and grown from the feces of healthy volunteers.…”

Section: Recent Advances Based On Microbiome In Ibd Treatmentmentioning

confidence: 99%

“…45 In conjunction with Vedanta, Seres Therapeutics promotes the development of SER-287, a consortium of several Firmicutes spores which has been evaluated in a phase 2 study. 223 SER-301, a more contemporary LBP that has reached phase 1 trials, consists of a collection of 18 live human commensal bacterial strains isolated and grown from the feces of healthy volunteers. In complement to these consortium strain mixes, single-strain LBP Bacteroides thetaiotaomicron (Thetanix) has shown improved mucus formation in the colon of gnotobiotic animal models and is being promoted for the management of IBD by 4D Pharma.…”

Section: Lbps and Ibdmentioning

confidence: 99%

The emerging microbiome‐based approaches to IBD therapy: From SCFAs to urolithin A

Rudiansyah

Jasim

Azizov³

et al. 2022

J of Digest Diseases

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“…This consortium mixture was discovered using a top-down gnotobiotic approach by transferring human-derived fecal microbiota after chloroform treatment (removes all but spores) into germ-free mice, after which subsequent mouse-tomouse transfers were carried out while selecting for the specific anti-inflammatory Treg expansion [44]. In addition to Vedanta, Seres Therapeutics is another company that is focused on the development of LBPs for IBD treatment with SER-287, which is a consortium of multiple Firmicutes spores and is currently in a Phase 2 clinical study (Figure 1, Table 1) [46]. A more recent LBP from Seres Therapeutics that has entered Phase 1 trials is SER-301, which comprises a set of 18 live human commensal bacterial strains that are purified and cultured from the stool of healthy donors.…”

Section: Live Biotherapeutic Productsmentioning

confidence: 99%

Mining the Microbiome and Microbiota-Derived Molecules in Inflammatory Bowel Disease

Bekkers

Stojkovic

Kaiko

2021

IJMS

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The intestinal microbiota is a complex community that consists of an ecosystem with a dynamic interplay between bacteria, fungi, archaea, and viruses. Recent advances in model systems have revealed that the gut microbiome is critical for maintaining homeostasis through metabolic digestive function, immune regulation, and intestinal barrier integrity. Taxonomic shifts in the intestinal microbiota are strongly correlated with a multitude of human diseases, including inflammatory bowel disease (IBD). However, many of these studies have been descriptive, and thus the understanding of the cause and effect relationship often remains unclear. Using non-human experimental model systems such as gnotobiotic mice, probiotic mono-colonization, or prebiotic supplementation, researchers have defined numerous species-level functions of the intestinal microbiota that have produced therapeutic candidates for IBD. Despite these advances, the molecular mechanisms responsible for the function of much of the microbiota and the interplay with host cellular processes remain areas of tremendous research potential. In particular, future research will need to unlock the functional molecular units of the microbiota in order to utilize this untapped resource of bioactive molecules for therapy. This review will highlight the advances and remaining challenges of microbiota-based functional studies and therapeutic discovery, specifically in IBD. One of the limiting factors for reviewing this topic is the nascent development of this area with information on some drug candidates still under early commercial development. We will also highlight the current and evolving strategies, including in the biotech industry, used for the discovery of microbiota-derived bioactive molecules in health and disease.

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P421 SER-287, an investigational microbiome therapeutic, induces remission and endoscopic improvement in a placebo-controlled, double-blind randomised trial in patients with active mild-to-moderate ulcerative colitis

Cited by 5 publications

References 0 publications

Gut microbiota-derived metabolites as key actors in inflammatory bowel disease

Gut microbiota-derived metabolites as key actors in inflammatory bowel disease

The emerging microbiome‐based approaches to IBD therapy: From SCFAs to urolithin A

Mining the Microbiome and Microbiota-Derived Molecules in Inflammatory Bowel Disease

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