Ex vivo data from candidate KB109, under evaluation in two clinical studies for COVID-19, to be presented at IDWeek 2020
Data from studies of KB39 and KB174 to be presented at The Liver Meeting® 2020, the AASLD Annual Meeting
LEXINGTON, Mass., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO), today announced that data from its Microbiome Metabolic Therapy (MMT™) programs for hepatic encephalopathy, cardiovascular and liver disease, and COVID-19 disease have been accepted for poster presentations at upcoming scientific conferences. Data from the MMT program KB109, under evaluation in two clinical studies in the treatment of mild-to-moderate COVID-19 disease, will be featured at the Infectious Disease Society of America’s Infectious Disease Week (IDWeek) 2020, taking place Oct. 21-25, 2020 in a virtual format. Candidates KB39 and KB174 will be featured during The Liver Meeting® 2020, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place Nov. 13-16, 2020, also in a virtual format.
“The results to be presented for KB109 will include its effect ex vivo on decreasing pathogens, increasing beneficial commensal bacteria, and increasing short chain fatty acid production supporting its potential in addressing viral respiratory infection by promoting appropriate immune function. In addition, we are pleased to present preclinical results for KB39 and expect to nominate an MMT therapy candidate with potential for development in the treatment of cardiometabolic and liver diseases in 2021,” commented Katharine Knobil, M.D., Chief Medical Officer and Head of Research & Development at Kaleido. “Finally, additional analyses from our clinical study of KB174 in patients with well-compensated cirrhosis improve our understanding of the mechanism in the potential treatment of hepatic encephalopathy, and also help to explain the reductions in microbiome nitrogen metabolism observed in several studies. The attributes of KB174 and the strengths of an MMT approach continue to show excellent promise for this indication.”
IDWeek 2020 Presentation:
Abstract Title: Development of a Novel Synthetic Glycan to Prevent Bacterial Infections and Ameliorate Respiratory Viral Infections (Poster #0610)
Lead Author: Jeffrey Meisner – Associate Director of Biology, Kaleido Biosciences
The Liver Meeting® 2020 presentations:
Abstract Title: KB39, a novel synthetic glycan modulating the gut microbiome, decreases fatty liver and atherosclerosis in diet-induced murine models of non-alcoholic fatty liver and cardiovascular disease (Poster #616)
Lead Author: Yves Millet – Director of Biology, Kaleido Biosciences
Abstract Title: 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 (Poster #610)
Lead Author: Jonathan Lawrence – Director of Chemistry, Kaleido Biosciences
KB109 has demonstrated the ability to reduce the relative abundance of a diversity of pathogenic bacteria and increased commensal bacteria in human fecal communities. Ex vivo screening revealed that KB109 consistently increased short chain fatty acid (SFCA) production across multiple fecal communities.
In mouse models, administration of KB39 resulted in a significant decrease in indicators of disease, including hepatic triglycerides, NAFLD activity score, blood triglycerides, total cholesterol, free fatty acids, LDL-C and VLDL-C. Effects of KB39 were associated with a 64 percent reduction in a mouse model of atherosclerotic plaque formation.
Observations of dose-dependent shifts in microbiome composition and an increase in Parabacteroides bacteria in patients provide support for the mechanism for KB174 in reducing gut associated ammonia, potentially through promoting bacterial species known to ferment glycans and thereby outcompeting ammonia-producing bacteria.
Presentations from the IDWeek conference will be available Oct. 21, 2020, and presentations from the AASLD annual meeting will be available on Nov. 13, 2020, at the Company’s website at https://kaleido.com/publications-and-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 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/.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the therapeutic potential of our MMT candidates, the timing of initiation, completion and reporting of results of clinical studies, and our strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the breadth of our pipeline of product candidates, the strength of our proprietary product platform, the efficiency of our discovery and development approach, the clinical development and safety profile of our MMT candidates and their therapeutic potential, whether and when, if at all, our MMT candidates will receive approval from the U.S. Food and Drug Administration and for which, if any, indications, competition from other biotechnology companies, and other risks identified in our SEC filings, including our most recent Form 10-Q, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
William Duke, Jr.
Chief Financial Officer
Lee M. Stern