LEXINGTON, Mass., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO), today announced Johan van Hylckama Vlieg, Ph.D., Chief Scientific Officer, will present at the Keystone Symposium “Harnessing the Microbiome for Disease Prevention and Therapy” conference this afternoon at 12:15 p.m. MST. The presentation will provide an update on progress with the Kaleido MMTTM platform, including a review of the K031 COVID-19 study interim data that were announced on January 14, 2021.
“We are pleased to have this opportunity to present our chemistry-driven approach to leverage the therapeutic potential of the microbiome and additional details of our interim analysis, including statistical analysis of the effects of KB109 on symptom resolution in patients with mild-to-moderate COVID-19,” commented Johan van Hylckama Vlieg, Ph.D., Chief Scientific Officer of Kaleido. “These clinical data further validate our platform and support the increasingly recognized role of the microbiome in driving immune function. It also highlights the ability of our MMTs to modulate the microbiome and their potential to induce a clinically meaningful effect. The data are promising for our COVID-19 program and support the approach we are taking across a range of disease areas, including ulcerative colitis and applications in immuno-oncology.”
Details of the presentation are as follows:
Presentation Title: Synthetic Glycans to Optimize Microbiome Composition and Function Session Title: Clinical Trials to Optimize Microbiome-Mediated Disease Resistance (EK12) Session Time: 12:15 p.m. MST
In May of 2019, Kaleido initiated two non-IND controlled clinical studies evaluating MMT candidate KB109 added to Supportive Self-Care (SSC) for outpatients with mild to moderate COVID-19 disease. Patients in each study were randomized within 48 hours of testing positive for COVID-19 to either receive Supportive Self Care (SSC) or SSC plus Microbiome Metabolic Therapy (MMT™) candidate KB109 for two weeks and then followed for an additional three weeks.
The first study, K031, is a multi-center study of approximately 350 patients. On January 14, 2021, Kaleido announced positive interim results from a planned interim analysis comprised of approximately half of the total study population (n=176). The interim analysis showed that KB109 was well tolerated, with a safety profile consistent with previous studies of MMT candidates and no unexpected treatment-related adverse events. For subjects reporting one or more comorbidities, which represented approximately 40 percent of patients, the median time to resolution of the thirteen overall COVID-19 related symptoms was 18 days with KB109 plus SSC and 27 days with SSC alone (Hazard Ratio (HR) = 1.800 and 95% Confidence Interval (CI) of 0.953 to 3.400). No difference in median time to resolution of symptoms was observed with KB109 plus SSC for the overall population, although small differences between the arms were observed during the follow-up period (HR = 1.328, CI = 0.862 to 2.047). Median time to resolution of the thirteen overall COVID-19 related symptoms for patients with one or more comorbidity at baseline was 18 days for the KB109 plus SSC group as compared with 27 days with SSC alone (HR = 1.4986, CI = 0.7679 to 2.9247). Kaleido also evaluated eight cardinal COVID-19 related symptoms as defined by the Centers for Disease Control and Prevention, which showed median time to resolution of symptoms among patients with one or more comorbidity at baseline was 15 days for the KB109 plus SSC group as compared with 27 days with SSC alone (HR = 2.0384, CI = 1.0279 to 4.0422). Additional data is available on the Events and Presentations section of Kaleido’s website: https://investors.kaleido.com/events-presentations.
The K031 study of 350 subjects is fully enrolled with results expected in the first quarter of 2021. A smaller study evaluating microbiome changes (K032) of approximately 50 mild to moderate patients with COVID-19 is also expected to provide topline in the first quarter of 2021, with microbiome sequencing available in the second quarter of 2021.
About the Potential Role of the Microbiome in COVID-19
COVID-19 infection has been associated with activation of an inappropriate inflammatory cascade, which in some patients can cause an abnormally aggressive immune response that can lead to pneumonia and respiratory failure. Metabolites such as short chain fatty acids (SCFAs) produced by the microbiome through utilization of glycans are modulators of the immune response and therefore could play a role in limiting this inflammatory cascade. In preclinical models, increased SFCAs and/or SFCA-producing taxa, have been shown to influence immune pathways, mitigate immune pathology, and improve survival and morbidity associated with severe respiratory viral infections.1,2 Commensal microbiota composition critically regulates the generation of virus-specific CD4 and CD8 T cells and antibody responses following respiratory influenza virus infection.3
In-human data also support the role of SCFAs in reducing the impact of viral infections. In patients undergoing hematopoietic stem cell transplants who have contracted respiratory viral infections, including coronavirus, the presence of SCFA-producing taxa has been associated with a significantly reduced risk of progression to lower respiratory tract infections, which can have substantial morbidity in this patient population.4 KB109 is Generally Recognized as Safe (GRAS) and was selected for evaluation in these COVID-19 clinical studies based on its demonstrated ability to increase production of SCFAs as well as to promote commensal bacteria and reduce pathogenic bacteria ex vivo.
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., 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 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 fact that interim results from KB013 may not accurately predict final results from KB013 and that such final results may not support continued development of KB109, 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. ___________________________________________________________________________
Antunes, K.H., et al. Microbiota-derived acetate protects against respiratory syncytial virus infection through a GPR43-type 1 interferon response. Nat Commun. 2019, 10, 3273.
Trompette, A., et al. Dietary Fiber Confers Protection against Flu by Shaping Ly6c- Patrolling Monocyte Hematopoiesis and CD8+ T Cell Metabolism. Immunity. 2018, May 15;48(5):992-1005.e8.
Ichinohe, T., et. al. Microbiota regulates immune defense against respiratory tract influenza A virus infection. Proceedings of the National Academy of Sciences. Mar 2011, 108 (13) 5354-5359.
Haak, B.W., et al. Impact of gut colonization with butyrate-producing microbiota on respiratory viral infection following allo-HCT. Blood. 2018. 131, 2978-2986.
Contacts Kaleido Biosciences William Duke, Jr. Chief Financial Officer 617-890-5772 william.duke@kaleido.com
