The microbiome is implicated in numerous diseases and health conditions. Learn how Kaleido is leading a differentiated approach to translating the promise of the microbiome into solutions for patients.
MMTs work through one or more mechanisms of action: increasing the production of metabolites, decreasing the production of metabolites, and advantaging or disadvantaging certain species in the microbiome community.
At Kaleido, we are breaking the mold of traditional discovery and development by using a human-centric approach. We study MMTs in microbiome samples in an ex vivo setting, followed by advancing 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. Our approach has the potential to be faster and more cost efficient than traditional discovery and development. We initiated our first Phase 2 clinical trial under an IND for one of our MMT candidates approximately two years after conducting our first ex vivo screening.
The human microbiome is the community of more than 30 trillion microbes, single-cell organisms that include bacteria, viruses, archaea and fungi, which reside on and inside the human body. Over the last decade research has increased exponentially on the impact the microbiome has on human health, including cardiovascular disease, cancer, diabetes, Parkinson’s disease and allergies. This highly complex microbial ecosystem has been referred to as a “newly discovered organ.” Many other human organs command tens of billions of dollars for therapeutics that treat disease by modulating physiology. From a therapeutic perspective, the microbiome organ remains a largely untapped frontier in healthcare.