Broad Pipeline

Kaleido has a broad pipeline of Microbiome Metabolic Therapy candidates (MMT) across a variety of diseases and conditions with significant unmet need. These include multiple clinical programs that have advanced into human studies as well as earlier programs aimed at expanding Kaleido’s MMT platform and clinical pipeline in 2021 and beyond.*

Product Candidate
Program
Clinical Development Status
Results Expected
+
KB195
Urea Cycle Disorders
Сlinical study1 in healthy volunteers
Сlinical study1 in patients
Phase 2 clinical trial (UNLOCKED) under IND/CTAs
2H 2021
Urea Cycle Disorders (UCD)

UCD is a rare, serious genetic disease caused by a deficiency in enzymes that constitute the urea cycle. UCD can result in ammonia accumulation in the brain where it can cause irreversible brain damage, coma and/or death. A significant proportion of ammonia is produced by the gut microbiome.

Kaleido completed clinical studies of KB195 in healthy volunteers and in patients with UCD, and has an ongoing Phase 2 clinical trial of KB195 under IND/CTAs in UCD patients who are inadequately controlled on standard of care.

+
KB174
Hepatic Encephalopathy
Сlinical study1 in healthy volunteers
Сlinical study1 in patients with cirrhosis
Clinical study1 in patients with HE2
Hepatic Encephalopathy (HE)

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, including cirrhosis. Patients with cirrhosis have an increased risk of developing bacterial infections, which can also cause an episode of HE.

KB174 showed the ability to lower both ammonia and multidrug-resistant (MDR) pathogens in ex vivo studies. Based on positive results from a clinical study in cirrhosis patients, the next planned study of KB174 will evaluate clinical endpoints in patients with HE.

+
KB109
COVID-19
Pathogens3
Clinical studies1 in patients with mild moderate SARS-COV-2
Patients with high risk for MDR infections
Q4 2020
COVID-19

Evidence from Kaleido’s ex vivo work suggests that KB109 increases the production of short chain fatty acids, metabolites that have been shown to impact the immune response in viral respiratory infections, as well as promotes commensal bacteria and reduces pathogenic bacteria. Data suggest short chain fatty acids may mitigate the inappropriate immune response to COVID-19 and avoid more serious complication of SARs-Cov-2 infection.

KB109 is being evaluated in controlled clinical studies in outpatients with mild-to-moderate COVID-19.

Pathogens

Kaleido is evaluating next steps for its pathogens program, including the potential to conduct a study in a patient population at high-risk of infections such as Hematopoietic Stem Cell Transplantation (HSCT) recipients.

+
KB295
Inflammatory Bowel Disease (IBD)
Clinical study1 in patients with ulcerative colitis
Mid-2021
Inflammatory Bowel Disease

Kaleido is exploring the potential of MMTs to addressing a number of immune-mediated and inflammatory diseases, including inflammatory bowel diseases such as ulcerative colitis (UC), which causes irritation, inflammation, and ulcers in the lining of the large intestine.

In ex vivo studies, KB295 showed the ability to increase certain beneficial short chain fatty acids and suppress the growth of bacteria associated with inflammation in the gut microbiome, supporting its evaluation in UC. During 2020, Kaleido plans to initiate a clinical study evaluating KB295 in approximately 30 patients with mild-to-moderate UC.

Completed Clinical Study
Clinical Study or Trial in Progress
Clinical Study Planned
Potential Next Clinical Study
Note:
  1. Our clinical human studies of our MMT candidates are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect in human subjects. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.
  2. Initiation gated on partner
  3. VITORA study of KV109 paused due to COVID-19

Preclinical Programs

 

Preclinical Program
Collaborator
Clinical-ready Lead MMT Expected in 2021
+
Immuno-oncology
Title

Description

+
Cardiometabolic & Liver Diseases
Title

Description

+
Immune-mediated Diseases
Title

Description

+
Prevention of Childhood-Onset Atopic & Immune Conditions
Title

Description

*Our human clinical studies of our MMT candidates 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, Kaleido conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development; for those that we elect to continue on a non-drug development pathway, INDs or regulatory equivalent outside the U.S. will not be required.