Using our proprietary product platform, we have created a library of more than 1,000 MMT candidates. Our MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the organ’s existing microbes. Our initial MMT candidates are targeted glycans and our library of MMTs is rapidly growing. Our MMTs are novel, proprietary compounds that are orally administered, selectively metabolized in the gut and have limited systemic exposure. Our MMTs are also related to a class that is generally recognized as safe or GRAS. We are advancing a pipeline of MMTs in multiple therapeutic areas, click here to learn more.
The microbiome produces metabolites that are essential for human health. In many ways the microbiome operates as another human organ, metabolizing nutrients that are otherwise unavailable to humans and interacting with many parts of the body through biochemical signals. Kaleido’s MMTs are designed to drive the function and distribution of the microbiome’s existing microbes. 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 to allow us to more effectively advance optimized, data-rich product candidates. We conduct ex vivo screening of microbiomes from healthy volunteers and ex vivo testing of patient microbiomes, which enables the integration of human data at the earliest stages. We are also able to advance our MMTs into non-IND human clinical studies under regulations supporting research with food. After conducting these studies, we determine whether or not to pursue an MMT as a drug product and file an IND, or pursue non-drug development opportunities. Our approach has the potential to be faster and more cost efficient than traditional drug development. We plan to initiate our first Phase 2 clinical trial under IND for one of our MMT candidates in the first half of 2019, 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.