Top-line safety, tolerability and activity results expected in mid-2021

LEXINGTON, Mass., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO) today announced that the first patient has been dosed in its clinical study evaluating Microbiome Metabolic Therapy (MMT™) candidate KB295 in patients with mild-to-moderate ulcerative colitis (UC).

“Alteration of the gut microbiome plays an important role in the development of UC,” said Katharine Knobil, M.D., Kaleido’s Chief Medical Officer and Head of Research & Development. “Our research with patient samples demonstrates that KB295 decreases pro-inflammatory species and promotes the production of beneficial metabolites in the gut microbiome that may impact the progression of UC. We look forward to evaluating the potential of KB295 in UC in this clinical study, with top-line data from the study expected in mid-2021.”

UC is an inflammatory bowel disease that can cause debilitating symptoms, including abdominal pain, bowel urgency and diarrhea. Evidence suggests that a feature of UC is alteration of the gut microbiome, including an increase in inflammatory bacteria and decrease in commensal diversity which interfere with the normal immune response. In ex vivo studies, KB295 has demonstrated the ability to increase the production of short chain fatty acids and suppress the growth of inflammatory bacteria such as Enterobacteriaceae.

“There is a growing body of evidence supporting the potential to address inflammatory diseases like UC by influencing the microbiome,” said Ted Dinan, M.D., Ph.D., Medical Director of Atlantia Food Clinical Trials Ltd and Principal Investigator at the APC Microbiome Ireland Research Center at University College Cork. “We see significant promise for KB295 in the treatment of UC with the field of microbiome-directed approaches because of its distinctive mechanism targeting microbiome metabolism and function.”

This non-IND/non-CTA open label, single arm clinical study is expected to enroll approximately 30 patients with mild-to-moderate UC. Patients will receive KB295 for eight weeks titrated up to 40 g twice daily and then enter a one-month follow-up period. The study will evaluate the safety and tolerability of KB295 and other assessments including the Simple Clinical Colitis Activity Index (SCCAI) composite score, changes in microbiome composition and biomarkers of inflammation.

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 rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., in Phase 2 or later development.

About Kaleido Biosciences