KB174 / Kaleido Biosci - LARVOL DELTA

[VIRTUAL] KB174 reduces relative abundance of multidrug resistance (MDR) enterobacteriaceae in fecal samples from patients with cirrhosis in an ex vivo test system (EASL-ILC-I 2020) - P=N/A | "These pathogens were spiked in and included two carbapenem-resistant Enterobacteriaceae (CRE) strains of E. coli (CDC AR Bank #0001) and K. pneumoniae (CDC AR Bank #0003), and a vancomycin-resistant Enterococci (VRE) strain, E. faecium (ATCC 700221)...One MMT, KB174, was further tested for reduction of CRE E. coli which was spiked into fecal samples from 25 patients with cirrhosis who were not on lactulose or rifaximin and 19 healthy controls... KB174 reduces the relative abundance of pathobionts in fecal samples from patients with cirrhosis. Based on these results, KB174 was investigated in a clinical study in cirrhotic patients (NCT03855956)."

Fibrosis • Hepatology • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

[VIRTUAL] COMMUNITY SHIFT IN THE GUT MICROBIOME IS A POTENTIAL MECHANISM FOR REDUCTION IN GUT MICROBIOTA-ASSOCIATED AMMONIA BY THE NOVEL SYNTHETIC GLYCAN, KB174, IN PATIENTS WITH WELL-COMPENSATED CIRRHOSIS (AASLD 2020) - "The dose-dependent microbiome shifts and increase in Parabacteroides induced by KB174 observed in this clinical study of patients with well-compensated cirrhosis corroborates findings from both ex vivo testing and clinical results from healthy subjects. It also supports the proposed mechanism that KB174 reduced gut associated ammonia through specifically modulating the microbiome composition, likely by promoting Parabacteroides, a core commensal taxa known to ferment glycans to propionate as the primary fermentation end-product, which in turn outcompetes ammonia-producing bacteria. Future work is expected to focus on patients with cirrhosis who exhibit psychomotor function abnormalities consistent with hepatic encephalopathy."

Clinical • CNS Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology

[VIRTUAL] A randomized, double-blind study to evaluate the safety and tolerability of KB174, a novel synthetic glycan, in patients with well-compensated cirrhosis (EASL-ILC-I 2020) - "This is the first clinical study to report the effect of KB174 in patients with cirrhosis. KB174 titrated up to 72g was shown to be well tolerated with no clinically significant safety signals observed in patients with well-compensated cirrhosis."

Clinical • CNS Disorders • Fibrosis • Gastrointestinal Disorder • Hepatic Encephalopathy • Hepatology • Immunology

KB174 REDUCES RELATIVE ABUNDANCE OF MULTIDRUG RESISTANT (MDR) ENTEROBACTERIACEAE IN FECAL SAMPLES FROM PATIENTS WITH CIRRHOSIS IN AN EX VIVO TEST SYSTEM (DDW 2020) - P=N/A | "Pathogens were added to fecal samples, which included carbapenem-resistant Enterobacteriaceae (CRE) strains of E. coli (CDC AR Bank #0001) and K. pneumoniae (CDC AR Bank #0003), and a vancomycin-resistant Enterococci (VRE) strain, E. faecium (ATCC 700221)...Subsequently, one of the best performing MMTs, KB174, was further evaluated using fecal samples (to which CRE E. coli was added) from 25 patients with cirrhosis who were not on lactulose or rifaximin and 19 healthy controls... KB174 reduces the relative abundance of pathobionts in fecal samples from patients with cirrhosis. Based on these results, KB174 was investigated in a clinical study in cirrhotic patients (NCT03855956)"

Fibrosis • Hepatology • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis (clinicaltrials.gov) - P=N/A; N=40; Completed; Sponsor: Kaleido Biosciences; Recruiting ➔ Completed; Trial completion date: Feb 2020 ➔ Oct 2019

Clinical • Trial completion • Trial completion date • Fibrosis • Gastroenterology • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Liver Cancer • Oncology • Solid Tumor

A RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF KB174, A NOVEL SYNTHETIC GLYCAN, IN PATIENTS WITH WELL-COMPENSATED CIRRHOSIS (DDW 2020) - "This is the first clinical study to report the effect of KB174 in patients with cirrhosis. KB174 titrated up to 72g was shown to be well tolerated with no clinically significant safety signals observed in patients with well-compensated cirrhosis"

Clinical • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Metabolic Disorders