On August 10, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported a strategic collaboration with the COPD Foundation to study KB109 in patients with chronic obstructive pulmonary disease (COPD) (Press release, Kaleido Biosciences, AUG 10, 2021, View Source [SID1234586191]). The collaboration will partner Kaleido with the COPD Foundation’s leading experts in its Digital Health and Therapeutics Accelerator Network, COPD360Net, to support joint clinical development starting with a Phase 2a trial of KB109, a novel Microbiome Metabolic Therapy (MMT), in COPD.
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An expanding body of research indicates that immune and inflammatory responses in the lung are in part driven by the gut microbiome – via the so-called gut-lung axis – making the gut microbiome a potential therapeutic target in COPD. KB109’s clinical potential to target the gut-lung axis and improve outcomes in respiratory viral diseases was demonstrated in a study of mild-to-moderate COVID-19 patients. Its mechanism of action is pathogen agnostic, suggesting it could address a wide range of chronic respiratory diseases driven by inflammation or respiratory infections. COPD is the most prevalent chronic respiratory illness, impacting over 250 million people worldwide, and has limited safe and effective treatment options for the control and prevention of acute exacerbations.
"We are excited to embark on this partnership with the COPD Foundation to work towards our shared mission to bring about innovative therapies for people suffering from COPD," said Dan Menichella, President and Chief Executive Officer of Kaleido. "The previous KB109 COVID-19 trial demonstrated activity against the pathologies associated with respiratory viral infections by modulating the gut microbiome and host immune system. We believe this result warrants clinical investigation of KB109 in COPD patients, and we look forward to initiating a Phase 2a trial early in 2022."
COPD Foundation’s President and Chief Scientific Officer Ruth Tal-Singer, PhD added, "At the Foundation, we were excited when we saw the KB109 COVID-19 data because of its potential to improve recovery from viral infections for patients with comorbidities. The COPD burden is projected to increase in the coming decades because of continued exposure to risk factors and the aging population. COPD patients would benefit from an oral therapy that could reduce exacerbations and improve quality of life. We are proud to partner with Kaleido in our continued efforts to find a treatment intervention that is affordable and potentially more efficacious for patients."
Patients with severe Acute Exacerbations in COPD (AECOPDs) often require hospitalization and have an increased mortality risk. COPD is not curable, but treatment can relieve symptoms, improve quality of life and reduce the risk of death. The majority of AECOPDs are triggered by respiratory tract viral or bacterial infections which result in lung microbiome dysbiosis, host immunity dysregulation, and pro-inflammatory cascades. With this collaboration, Kaleido and the COPD Foundation intend to further capitalize on KB109’s potential to correct dysbiosis and prevent significant disease burden related to respiratory infections in people with COPD.
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.