Press Releases 10.03.2019
Kaleido Biosciences Presents Ex Vivo Data of KB109 Demonstrating Reduction of Multi-drug Resistant Pathogens at IDWeek 2019™
Additional Presentation on Platform at Upcoming Keystone Symposia on the Microbiome: Therapeutic Implications
LEXINGTON, Mass., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, today announced that ex vivo and in vivo data evaluating its Microbiome Metabolic Therapies (MMT™) are being presented at IDWeek 2019™ and the Keystone Symposia on the Microbiome: Therapeutic Implications.
Kaleido is advancing MMT candidate, KB109, in clinical development to decrease colonization with multi-drug resistant (MDR) pathogens by selectively enhancing the growth of beneficial bacteria in the gut and reducing the risk of infection. Ex vivo data of KB109 are featured today in a poster presentation during IDWeek, which is being held in Washington, D.C., through October 6, 2019.
Critically ill and immunocompromised patients are more vulnerable to MDR pathogens such as carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococcus (VRE), leading to a higher risk of serious infections. The Centers for Disease Control and Prevention (CDC) has estimated that in the United States alone, at least two million people are infected with bacteria resistant to antibiotics each year and at least 23,000 people die from these infections. The CDC has categorized CRE as an urgent threat and VRE as a serious threat.
In ex vivo data presented at IDWeek, KB109 reduced the relative abundance of pathogens in microbiome samples from two different populations at high risk for infection, patients in the intensive care unit who had received broad-spectrum antibiotics and patients with end-stage liver disease. KB109 reduced the relative abundance of pathogens, including CRE, in all samples from intensive care unit patients that had commensal bacteria. KB109 also reduced the abundance of VRE and CRE in all samples from patients with end-stage liver disease. In both ex vivo experiments, KB109 did not favor the growth of Clostridium difficile and other pathogens frequently found in critically ill and immunocompromised patients.
“There is a significant need for new approaches to address infections caused by multi-drug resistant pathogens like CRE and VRE, which are a growing public health threat. Research suggests the composition of the gut microbiome plays a significant role in influencing the ability of the body to resist infection,” said Johan van Hylckama Vlieg, Ph.D., Chief Scientific Officer of Kaleido. “These ex vivo data demonstrate that KB109 effectively reduced MDR pathogen growth, and we are excited to have a clinical study underway to evaluate the potential of this MMT candidate in patients.”
The VITORA clinical study will assess the safety and tolerability of KB109 compared to control in patients colonized with MDR pathogens, and evaluate the change in colonization of VRE, extended-spectrum beta lactamase (ESBL)-producing Enterobacteriaceae, and CRE. Additional information on the study can be found at https://clinicaltrials.gov/ using identifier NCT03944369.
The IDWeek poster, “Novel Glycans Reduce Carbapenem-Resistant Enterobacteriaceae and Vancomycin-Resistant Enterococcus Colonization in an Ex Vivo Assay by Supporting Growth and Diversity of Commensal Microbiota at the Expense of Multi-Drug Resistant Organisms” will be available on Kaleido’s website at: https://kaleido.com/platform/#publications.
At the Keystone Symposia on the Microbiome: Therapeutic Implications being held in County Kerry, Ireland, October 6-10, 2019, data will be presented in a poster session highlighting the potential of Kaleido’s platform in the discovery and development of MMTs. These ex vivo and in vivo data demonstrate the ability of MMTs to reduce the toxic side effects of chemotherapy through multiple mechanisms, including the production of short chain fatty acids and taxonomic restructuring of the microbiome. The poster, “Chemical Modulation of the Gut Microbiome Alleviates Chemotherapy-Induced Toxicity,” will be available following the presentation on Kaleido’s website at: https://kaleido.com/platform/#publications.
About Microbiome Metabolic Therapies (MMT™)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome organ’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 glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its human-centric discovery and development platform to study MMTs in microbiome samples in an ex vivo setting, followed by advancing MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies, including the VITORA study, 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., and in Phase 2 or later development.
About Kaleido Biosciences
Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to leveraging the potential of the microbiome organ to treat disease and improve human health. The Company has built a human-centric 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 organ’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 and the VITORA clinical study. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar words and expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words or expressions. 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 non-IND clinical studies of our MMT product candidates including statements regarding the rapidity at which our human-centric discovery and development platform can advance our MMT product candidates, 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 form 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 Quarterly Report on Form 10-Q, and subsequent filings with the SEC. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.