KB109 / Kaleido Biosci - LARVOL DELTA

The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects. (PubMed, Biomedicines) - "Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons...The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI."

Journal • Review • Developmental Disorders • Infectious Disease

Kaleido Biosciences Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "The Company remains on track to initiate a Phase 2 clinical trial of KB109 in patients with chronic obstructive pulmonary disease (COPD) in the first half of 2022, in collaboration with the COPD Foundation."

New P2 trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Kaleido Biosciences to Host Virtual R&D Presentation to Discuss Clinical Data and Pipeline Advancement on October 5, 2021 (Wallstreet.org) - "The agenda will feature an update on the company's corporate strategy, data from the non-IND study evaluating KB295 in mild-to-moderate UC as well as supportive preclinical data, and data supporting the advancement of KB109 into COPD. KB295 and KB109 are novel, orally administered Microbiome Metabolic Therapies (MMT) developed using Kaleido's proprietary synthetic chemistry technology."

Live event

Kaleido Biosciences to Host Virtual R&D Presentation to Discuss Clinical Data and Pipeline Advancement on October 5, 2021 (Yahoo Finance) - "Company plans to advance both KB295 and KB109 to Phase 2 studies....Kaleido Biosciences, Inc...today announced that it will host a virtual R&D Presentation on October 5, 2021, at 8 a.m. ET. The agenda will feature an update on the Company’s corporate strategy...data supporting the advancement of KB109 into COPD."

New P2 trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120 (clinicaltrials.gov) - P=N/A; N=333; Completed; Sponsor: Kaleido Biosciences; Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function (clinicaltrials.gov) - P=N/A; N=49; Completed; Sponsor: Kaleido Biosciences; Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19 (clinicaltrials.gov) - P=N/A; N=350; Completed; Sponsor: Kaleido Biosciences; Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Kaleido Biosciences and the COPD Foundation Announce a Strategic Collaboration to Advance KB109 into Phase 2 Clinical Trial (GlobeNewswire) - "Kaleido Biosciences, Inc...today announced a strategic collaboration with the COPD Foundation to study KB109 in patients with chronic obstructive pulmonary disease (COPD). 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....'We look forward to initiating a Phase 2a trial early in 2022.'"

Licensing / partnership • New P2a trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Targeting the Microbiome with KB109 in Mild to Moderate COVID-19 Reduced Healthcare Utilization and Symptom Duration (WMF 2021) - "These results suggest that administration of KB109 may be associated with reduced times to resolution of COVID-19 symptoms and decreased rates of medically attended visits in non-hospitalized patients with mild to moderate COVID-19, especially in older patients and those with ≥1 comorbidity. Future evaluation of KB109 in larger studies is warranted to build upon these results and evaluate whether KB109 can reduce the development of long-term COVID-19 symptoms and symptom duration of other infections."

HEOR • Hypertension • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Impact of one or more comorbidities and the microbiome metabolic therapy (MMT) KB109 on symptom resolution in non-hospitalised patients with mild to moderate COVID-19 (ECCMID 2021) - No abstract available

Clinical • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] Patient-reported comorbidity affects symptom duration in non-hospitalized patients with mild to moderate COVID-19 in a clinical study (IMMUNOLOGY 2021) - "We assessed outpatient natural history of COVID-19 as part of a clinical food study evaluating KB109 safety and its effects on select health measures when combined with supportive self-care (SSC) vs SSC alone... This is the first clinical study to show ≥1 comorbidity is associated with a protracted time to resolution of symptoms in non-hospitalized patients with mild to moderate COVID-19."

Clinical • Hypertension • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Kaleido Biosciences Reports First Quarter 2021 Financial Results (GlobeNewswire) - "Research and development (R&D) expenses were $17.2 million and $13.1 million for the three months ended March 31, 2021 and 2020, respectively. The increase was primarily due to increased spend relating to our two COVID-19 studies and the modification of the vesting provision of stock options..."

Commercial • Infectious Disease • Novel Coronavirus Disease

Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study. (PubMed, Trials) - P=N/A | "In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocols. The study protocols have been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional files 3 and 4)."

Clinical • Journal • Allergy • Fatigue • Fibrosis • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Immune Modulation • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Obstructive Sleep Apnea • Oncology • Otorhinolaryngology • Pain • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Kaleido Biosciences Reports Positive Results from Non-IND Study Demonstrating a Reduction in COVID-19 Related Healthcare Utilization and Recovery Time in Patients with Mild-to-Moderate COVID-19 and One or More Comorbidity (GlobeNewswire) - P=NA, N=350; NCT04414124; Sponsor: Kaleido Biosciences; "KB109 demonstrated an overall favorable safety and tolerability profile with no unexpected treatment-related adverse events; KB109 reduced healthcare utilization, as measured by the total number of hospitalizations, emergency room visits, and urgent care visits by approximately 62 percent among patients with one or more comorbidity and by approximately 51 percent overall; KB109 showed the greatest impact for patients with one or more underlying comorbidity, who have a considerably longer disease course....As a non-interventional extension to the completed study, Kaleido is continuing to study the impact of KB109 on the incidence of ‘Long-COVID’..."

Clinical data • New trial • Infectious Disease • Novel Coronavirus Disease

An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120 (clinicaltrials.gov) - P; N=300; Recruiting; Sponsor: Kaleido Biosciences

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease

A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function (clinicaltrials.gov) - P=N/A; N=50; Recruiting; Sponsor: Kaleido Biosciences; Initiation date: Jul 2020 ➔ Jan 2021

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms (clinicaltrials.gov) - P=N/A; N=3; Terminated; Sponsor: Kaleido Biosciences; N=50 ➔ 3; Trial completion date: Nov 2020 ➔ Jun 2020; Recruiting ➔ Terminated; Trial primary completion date: Nov 2020 ➔ Jun 2020; COVID-19 pandemic

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Disorder

A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19 (clinicaltrials.gov) - P=N/A; N=350; Active, not recruiting; Sponsor: Kaleido Biosciences; Recruiting ➔ Active, not recruiting; Trial primary completion date: Oct 2020 ➔ Feb 2021

Clinical • Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Kaleido Biosciences Announces Positive Interim Results of Controlled Study of KB109 in Patients with Mild-to-Moderate COVID-19 (GlobeNewswire) - P=NA, N=400; NCT04414124; Sponsor: Kaleido Biosciences; "Kaleido Biosciences, Inc....today announced positive interim results from the K031 non-IND controlled clinical study evaluating outpatients with mild to moderate COVID-19 disease....The planned interim analysis comprised approximately half of the total study population (n=176) and showed that KB109 was well tolerated, with a safety profile consistent with previous studies of MMT candidates and no unexpected treatment-related adverse events....The K031 study of 350 subjects is fully enrolled with results expected in the first quarter of 2021. Topline data from a smaller 50 subject study of KB109 is also expected in the first quarter of 2021."

Clinical data • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Kaleido Biosciences Announces Completion of Enrollment of 350 Subjects in Controlled Study of KB109 in the Treatment of Mild-to-Moderate COVID-19 (GlobeNewswire) - "Kaleido Biosciences, Inc....today announced that completion of enrollment of 350 subjects in the controlled clinical study K031 evaluating Microbiome Metabolic Therapy (MMT™) candidate KB109...'Reaching this point of full enrollment positions us to deliver on the goal of reporting topline results later this quarter. We also continue to expect topline data from our smaller study of KB109 in the first quarter of 2021.'"

Clinical data • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] Development of a Novel Synthetic Glycan to Prevent Bacterial Infections and Ameliorate Respiratory Viral Infections (IDWeek 2020) - "KB109 represents an appealing activity profile and offers an opportunity to prevent enteric and systemic bacterial infections by promoting gut homeostasis and colonization resistance, and ameliorating respiratory viral infections by stimulating immune homeostasis. KB109 is under evaluation in two COVID-19 clinical studies."

Infectious Disease • Novel Coronavirus Disease

Kaleido Biosciences Announces Data from MMT Programs Accepted for Presentation at Upcoming Scientific Conferences (GlobeNewswire) - "Kaleido Biosciences, Inc....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."

Live event • Preclinical • Infectious Disease • Novel Coronavirus Disease

Kaleido Biosciences Provides Update on KB109 Clinical Data Timeline (GlobeNewswire) - "Updated projections for enrollment of the multi-center K031 clinical study of approximately 350 patients indicated that top-line data will be available in the first quarter of 2021. Previous projections had indicated the potential availability of top-line data from the study in the fourth quarter of 2020."

Clinical data • Infectious Disease • Novel Coronavirus Disease

A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function (clinicaltrials.gov) - P=N/A; N=50; Recruiting; Sponsor: Kaleido Biosciences

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease

Kaleido Biosciences Initiates Controlled Clinical Study with Massachusetts General Hospital of Microbiome Metabolic Therapy KB109 in Outpatients with Mild-to-Moderate COVID-19 (GlobeNewswire) - "Kaleido Biosciences, Inc....today announced the initiation of a controlled clinical study...evaluating Microbiome Metabolic Therapy (MMT) candidate KB109 added to Supportive Self-Care....This non-IND clinical study (K032) aims to include approximately 50 COVID-19 positive outpatients with mild-to-moderate disease....The Company recently initiated a separate multi-center study....Top-line data from the ongoing multicenter study (K031) are expected in the fourth quarter of 2020 and top-line data from this study with Massachusetts General Hospital (K032) are expected in the first quarter of 2021."

Clinical data • Trial status • Infectious Disease • Novel Coronavirus Disease