Setting a New Standard of Care


herapeutics in the Western world are in desperate need of change. Many treat symptoms instead of underlying causes and come with a long list of side effects. For example, moderate to severe inflammatory bowel disease (IBD) is often treated with blockbuster TNF-alpha drugs that target inflammation by crippling the immune system. TNF-alpha drugs such as HUMIRA® and REMICADE® manage patients’ symptoms but do little to treat fundamental disease causes. Since these interventions are not curative, they have a high failure rate and patients often have long-term exposure to the medications. At Gusto Global we believe in improving the human condition by setting the standard of care for diseases linked to functional imbalances (dysbiosis) of the microbiome. Our novel live biotherapeutics and companion diagnostics offer the potential for safer and more personalized and precision therapeutics.

Gusto’s approach combines proprietary bioinformatics, AI, and microbiology expertise to identify differences in core microbiome functionalities between healthy and unhealthy individuals. By introducing never before seen self-sustaining consortia of beneficial bacteria we aim to rebalance the microbiome with nontoxic biotherapeutics that engraft in a patient’s system to seed missing core functionalities. We believe the future of medicine is one in which patients are not just managing their symptoms but are curing disease and achieving long-term health.

The driving force behind our therapeutics comes from the realization that bacteria play an enormous role in our overall health by controlling the first interactions that we as humans have with our environments. Bacteria colonize our skin, the female reproductive organs, our mouth, the lungs, and especially our gastrointestinal (GI) tract. While these bacterial communities differ strongly throughout the body, they all play similar important roles to keep us healthy. The microorganisms that live in our GI tract have especially been shown to affect their human host by aiding in the digestion of food and nutrition, regulating our mood, affecting our circadian rhythm and helping to regulate our immune system.

By introducing never before seen self-sustaining consortia of beneficial bacteria we aim to rebalance the microbiome…

A disruption of the gut microbiota can result in many different conditions including obesity and malnutrition, infections by the pathogenic bacterium Clostridium difficile, and chronic inflammatory diseases such as allergies, diabetes, plaque psoriasis and inflammatory bowel disease. Also, aging related diseases like Parkinson’s disease and Alzheimer’s disease have been linked to dysbiosis of the gut microbiome. Gusto is developing novel live biotherapeutic formulations in the context of systematically addressing this wide variety of complex conditions where microbiome community interactions play a significant role. Our formulations of bacteria are precisely designed to restore missing functionalities and achieve targeted immune modulation and optimization of metabolic pathways.

Gusto’s LBP efforts focus on the gut microbiome and the body’s immune response with two programs that have contrasting objectives:

Our IBD program seeks to change a pro-inflammatory dysbiotic gut microbiome to a healthy one, thereby restoring an overactive immune system and overcoming problems with the inflamed lining of the intestine. Multiple bacterial strains within our lead candidate, GUT-108, provide critical functions that are missing from the pro-inflammatory microbiome of IBD patients. These functions include synthesis of beneficial metabolites to support epithelial health and immune homeostasis, the conversion of bile acids, and the control of pathogenic bacteria that thrive in the inflamed GI tract. In collaboration with the Crohn’s and Colitis Foundation, GUT-108 is being validated in animal studies to delay relapse of IBD after treatment with immune suppressing drugs.

Gusto’s live biotherapeutic for immuno-oncology is engineered to modulate the gut microbiome of cancer patients that are non-responsive to immune checkpoint inhibitors, like KEYTRUDA®, by inciting a more active immune system that overcomes immune dormancy in the tumor environment. Our lead candidate, GUT-115, is being developed as an adjuvant therapy to immune checkpoint inhibitors, and seeks to provide critical functions to awaken the immune system and increase levels of tumor infiltrating immune cells.



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