LEXINGTON, Mass., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO), today announced an update to its ongoing COVID-19 clinical development program evaluating KB109 when added to supportive self-care (SSC) in outpatients with mild-to-moderate COVID-19 disease. Updated projections for enrollment of the multi-center K031 clinical study of approximately 350 patients indicated that top-line data will be available in the first quarter of 2021. Previous projections had indicated the potential availability of top-line data from the study in the fourth quarter of 2020.

“We are encouraged by the potential for KB109, a novel glycan developed with our MMT approach, to influence clinical outcomes in patients with COVID-19,” commented Michael Bonney, Executive Chair of Kaleido. “This delay in our timeline for the K031 study, while unexpected, is understandable given the dynamic nature of this emergent disease and the nature of its spread in different geographies. Results of our K032 clinical study of KB109 in approximately 50 patients with mild-to-moderate COVID-19, conducted in collaboration with Massachusetts General Hospital, continue to be expected in the first quarter of 2021. Guidance for our other programs is unchanged, with data from our study of KB295 in ulcerative colitis expected in mid-2021, results with KB195 in urea cycle disorder expected in the second half of 2021. With our clinical studies, we have instituted protocols to allow for virtual visits to reach patients who may not be near a study site or when needed in order to minimize the impact of disease transmission on study enrollment. In addition, we continue to expect preclinical data from our immuno-oncology, cardiometabolic and liver diseases programs this quarter (the fourth quarter of 2020).”

Additional information about the K031 study of MMT therapy KB109 in outpatients with mild-to-moderate COVID-19 infection is available at https://clinicaltrials.gov/ct2/show/NCT04414124. Information about the K032 study is available at https://clinicaltrials.gov/ct2/show/NCT04486482.

A patient may be eligible for enrollment in these studies if an initial positive COVID-19 test result is received and the patient remains symptomatic.

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 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

Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health. The Company has built a proprietary product platform to enable the rapid and cost-efficient discovery and development of novel Microbiome Metabolic Therapies (MMT™). MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the gut’s existing microbes. Kaleido is advancing a broad pipeline of MMT candidates with the potential to address a variety of diseases and conditions with significant unmet patient needs. To learn more, visit https://kaleido.com/.