Kaleido Biosciences to Present Updated Data of KB295 In Ulcerative Colitis at the 2022 Crohn’s and Colitis Congress
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Kaleido Biosciences to Present Updated Data of KB295 In Ulcerative Colitis at the 2022 Crohn’s and Colitis Congress

LEXINGTON, Mass., Jan. 21, 2022 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, today announced that the topline data obtained with KB295, a novel Microbiome Metabolic Therapy (MMT™), in mild-to-moderate ulcerative colitis (UC), will be presented virtually at the 2022 Crohn’s and Colitis Congress.

“The data show the direct effect of administering KB295 includes enriching diverse, beneficial commensal microbiota and restoring balanced SCFA production, while depleting harmful pathobionts in order to suppress inflammation and restore gut homeostasis,” said Dan Menichella, President and Chief Executive Officer of Kaleido. “This proof-of-principle clinical study also continues to clearly demonstrate that KB295 leads to decreases in important disease-associated biomarkers of intestinal inflammation. Kaleido has also been analyzing data from the full dataset, including the follow-up period, and looks forward to presenting that data at an upcoming medical meeting.”

KB295 was evaluated in an exploratory, open-label, single arm non-IND clinical study in subjects with mild-to-moderate UC. Subjects received KB295 for eight weeks, titrated up to 40g twice daily and then entered a two-week follow-up period. The primary objective of the study was to evaluate the safety and tolerability of KB295. Secondary objectives of the study were to evaluate changes in disease-associated biomarkers of intestinal inflammation including FCP, lactoferrin, and FimH, and change in composition of the gut microbiome. Primary pharmacology data were generated with Kaleido’s unique translational ex vivo platform using human donor-derived microbiome communities as well as microbiome and biomarker read-outs on samples from subjects that entered the study.

The Company will present the poster “The Synthetic Glycan KB295 Optimizes Microbiome Composition and Function in Ulcerative Colitis: Results from a Proof of Principle Human Study” on January 21. The poster will be made accessible for attendees and will also be made available on the Events and Presentations page of the Company’s website at https://investors.kaleido.com/events-presentations.

About Microbiome Metabolic Therapies (MMT™)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates into clinical studies in healthy subjects and subjects. These human clinical studies may be conducted under regulations supporting research with food, evaluating safety and tolerability and impact on the microbiome. For MMT candidates that are developed as therapeutics, the Company currently conducts and will conduct clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., often in Phase 2 or later development.