Table 1.
Microbiota-based Therapies in Development for IBD
Therapy Type | Company | Location | Product* | Delivery* | Development Stage | Mechanism |
---|---|---|---|---|---|---|
Ecology modulator | Enterome | USA | EB-8018 small molecule | oral | phase 2 study of patients with CD | prevents pathobiont invasion by blocking FIMH |
Immuron | Australia | N/A | oral | preclinical | antibodies and adjuvant to boost immune response to pathobionts | |
BiomX | Israel | BX002 | N/A | preclinical | bacteriophage to deplete pathobionts | |
Eligo | France | N/A | N/A | preclinical | Crispr-CAS to deplete pathobionts | |
Intralytix | USA | EcoActive | oral | phase 1 and 2a study of patients with CD | bacteriophage to target AIEC | |
Artizan Biosciences | USA | N/A | N/A | Preclinical | Subtractive therapy | |
Live Biotherapeutic Product | Seres Therapeutics | USA | SER287 naturally derived community | oral | phase 2 study of patients with UC | not available |
Seres Therapeutics Janssen (Vendanta License) | USA | SER301 defined community | oral | preclinical | not available | |
VE202 defined community | oral | phase 1 study of patients with UC | Induce Treg cells | |||
Rebiotix (acquired by Ferring) | USA | RBX2660 | enema | phase 1 in pediatric patients with UC | Restore microbiome composition | |
4D Pharma | UK | Thetanix B thetaiotamicron | oral | phase 1 study of patients with CD | not available | |
4D Pharma Osel | Rosburix R hominis | oral | preclinical | not available | ||
USA | CBM588 C butyricum | oral | phase 1 | Increase SCFAs | ||
ImmuneBiotech | Sweden | IB002 Lactobacilli | N/A | preclinical | not available | |
Actobiotic | USA | AG-014 GMO | oral | phase 1 | heterologous expression of anti-TNF nanobody by Lactobacillus | |
Rise Therapeutics | USA | R-3750 GMO | N/A | preclinical | Lactobacillus for heterologous expression | |
Nordisk Rebalance | Denmark | Profermin L latarum oats phosphatidylcholine | oral | marketed as food for special medical purpose | phase 2 of patients with UC, a prebiotic that increases SCFAs | |
Finch Therapeutics | USA | FIN524, defined community | oral | preclinical studies of colitis | not available | |
Allergan | Ireland | ABI-M201,301 | oral | preclinical | licensed from Assembly Biosciences and uses Gemicel coating | |
NextBiotix/Exeliom Biosciences | FRA | NBX-1650 | n/a | Preclinical | F. prausnitzii to treat inflammation | |
ViThera | USA | VT301 | Oral | Preclinical | Modified Lactobacilli strains | |
Chain Biotech | USA | CHN-1, CHN-2 | Oral | preclinical | anti-microbial peptide with Clostridium Assisted Drug Delivery | |
PanTheryx | USA | PTX-400 | Oral | Preclinical | Medical food - prebiotic | |
Microbial effectors | Host Therabiomics | UK/USA | L1173 | N/A | preclinical | platform to identify effectors |
Second Genome | USA | SG-2–0776 protein | oral | preclinical | intestinal healing | |
Symbiotix Biotherapies | USA | SYMB-104 polysaccharide A | N/A | preclinical | B fragilis-derived immune modulator | |
Alma Bio Therapeutics | FRA | N/A Plasmid | Injection | Preclinical | Plasmids that produce Heat Shock Proteins | |
Enterome | USA | EB110/EB220 | oral | preclinical | microbial metabolite associated with CD | |
Formulation | Finch Therapeutics | USA | aquashell | oral | N/A | pH release polysaccharide |
Intract Pharma | UK | phloral duocoat | oral | N/A | pH release | |
Prodigest | Belgium | in vitro microbiome model | N/A | N/A | predict in vivo conditions | |
Synlogic | USA | genetically modified organism | N/A | N/A | Not available | |
Assembly | USA | gemicel capsule | oral | N/A | pH release | |
Host Target | Second Genome | USA | SGM-1019 Small molecule | oral | phase 1 | modulates inflammasome |
N/A, not applicable because agent is in preclinical stage of development
Note: Companies were identified by the Janssen Human Microbiome Institute from public resources.