Kaleido Biosciences Announces Presentation of Data for Microbiome Metabolic Therapy KB174 for Hepatic Encephalopathy at The Digital International Liver Congress™ (EASL)

LEXINGTON, Mass., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO) today announced that data from Microbiome Metabolic Therapy (MMT™) candidate KB174 for hepatic encephalopathy (HE) will be featured during The Digital International Liver Congress™, the Annual Meeting of the European Association for the Study of the Liver (EASL). The results include details on the effects of KB174 on microbiome nitrogen metabolism in a clinical study in patients with well-compensated cirrhosis, the demonstration of improved tolerability for KB174 relative to lactulose in a study of healthy volunteers, as well as effects of MMTs on bacterial composition in patient samples ex vivo.

“The data being presented expand upon the previously reported topline clinical proof-of-concept results with KB174 showing the potential to reduce microbiome ammonia production as well as pathogens,” said Katharine Knobil, M.D., Chief Medical Officer and Head of Research & Development at Kaleido. “Given that ammonia is central to the pathogenesis of HE, the higher risk of infection in this susceptible population, and the favorable tolerability of KB174 relative to lactulose, which is currently used first line for HE, these results provide compelling support for continued development of KB174 as a novel therapy for this disease.”

Details of the poster presentations featured at The International Liver Congress™ follow. The presentations will be available at the Company’s website at https://kaleido.com/publications-and-presentations/.

Abstract Title: A randomized, double-blind study to evaluate the safety and tolerability of KB174, a novel synthetic glycan, in patients with well-compensated cirrhosis (Poster #4204)
Lead Author: Bal Raj Bhandari, M.D., Principal Investigator, Delta Research Partners LLC, Monroe, Louisiana.

Abstract Title: Microbiome Metabolic Therapies reduce microbiota-associated ammonia in ex vivo fecal samples from healthy subjects and patients with minimal hepatic encephalopathy and demonstrate improved tolerability over lactulose in a clinical study (Poster #4015)
Lead Author: Jasmohan Bajaj, M.D. Associate Professor of Medicine, Division of Gastroenterology, Hepatology, and Nutrition at Virginia Commonwealth University and McGuire VA Medical Center in Richmond, Virginia.

Abstract Title: KB174 reduces relative abundance of multidrug-resistant (MDR) Enterobacteriaceae in fecal samples from patients with cirrhosis in an ex vivo test system (Poster #4178)
Lead Author: Jasmohan Bajaj, M.D.

Key Highlights

• In a clinical study of patients with cirrhosis, treatment with KB174 was associated with a 26 percent median reduction in urinary ¹⁵N excretion, a biomarker of microbiome ammonia production, and was well tolerated with no clinically significant safety signals observed.
• In a separate clinical study of healthy subjects, KB174 was better tolerated than lactulose, the standard of care treatment for HE, based on several measures. In an ex vivo study evaluating microbiome samples of patients with minimal hepatic encephalopathy (MHE) and healthy subjects, KB174 demonstrated significantly greater reductions in net ammonia compared to lactulose (healthy: 55% vs 41% reduction compared with control group; MHE: 37% vs 25% reduction).
• KB174 also led to significant decreases in the relative abundance of carbapenem-resistant E. coli and Enterobacteriaceae in both healthy and cirrhotic patient microbiome samples ex vivo, supporting its potential to reduce the risk of pathogenic infection in susceptible populations. In addition, a greater reduction in relative abundance of Enterobacteriaceae was seen in 68% (17 of 25) of samples from cirrhosis patients when incubated with KB174 compared with lactulose.

About KB174

KB174, a novel MMT designed to modulate the metabolic output and profile of the microbiome, is Kaleido’s lead candidate in HE based on its ability to lower both ammonia and multidrug-resistant (MDR) pathogens, ex vivo. The gut microbiome plays a significant role in the production of ammonia. Ammonia is central to the pathogenesis of HE, which encompasses a spectrum of potentially reversible neurologic and psychiatric abnormalities generally seen in patients with liver disease. HE is a common complication of all forms of cirrhosis, leading to significant morbidity and mortality in this patient population. Patients with cirrhosis have an increased risk of developing bacterial infections, which can also cause an episode of HE.

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/.

Forward-Looking Statements

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 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 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.

Contacts

Kaleido Biosciences, Inc.
William Duke, Jr.
Chief Financial Officer
617-890-5772
[e-mail]

Investors
Lee M. Stern
Solebury Trout
646-378-2922
[e-mail]

Media
Rich Allan
Solebury Trout
646-378-2958
[e-mail]