Kaleido Biosciences said on Wednesday its experimental oral treatment cut recovery time as well as hospitalizations and emergency room visits in patients with mild to moderate COVID-19, in an early trial.
The treatment, KB109, reduced the total number of hospitalizations, emergency room visits, and urgent care visits by 51% in a study of 350 patients, and by 62% among patients with one or more co-morbidities, the company said in a statement (https://bit.ly/397TfX9).
The median recovery time for COVID-19 patients with one or more co-morbidities or who were aged 45 years and older shrank from 30 to 21 days, according to the drug developer.
KB109 is a targeted, synthetic glycan that the company describes as a Microbiome Metabolic Therapy, which works by changing the composition and metabolic output of microbes in the gut.
An aggressive immune response in some patients contributes to respiratory failure and pneumonia, and gut microbes can produce molecules, including short-chain fatty acids, that are believed to modulate such responses, Kaleido said.
The company said it registered the study with the U.S. Food and Drug Administration as a trial of a food compound, and not a therapeutic, adding that it plans to submit an application to begin investigational new drug clinical trials later this year.
"We believe based on this data that we can go directly to phase three (study)," Chief Executive Officer Daniel Menichella told Reuters.
Kaleido believes there is a market for microbiome-based therapies like KB109, due to their ease of administration.
