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.*

Clinical Development Programs

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.

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.

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. 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 out-patients with mild-to-moderate COVID-19.

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.

Preclinical Programs

*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.