Probiotic Prevention of C. difficile Infections
Safe Lactobacillus-based synthetic biologic as a colonization resistance agent of, and oral vaccine for, Clostridioides difficile infection (CDI).
The Problem
Clostridioides difficile (“Cdiff”) is a spore-forming bacterium that infects humans and non-human mammals worldwide and causes debilitating (sometimes fatal) diarrhea. Cdiff can persist in the GI tract for extended time periods, prevent the recovery of natural, protective microbiota, and thus potentiate recurrent cycles of disease. There is no vaccine to prevent CDI, and antibiotics remain the mainstay of treatment, increasing the likelihood of gut microbiome disruption as well as widespread antibiotic resistance. Thus, there is an urgent unmet need for a microbiome-sparing CDI treatment. In the USA, CDI treatment and mitigation results in a high and chronic health burden on patients and providers, with a ~$2B associated healthcare cost.
The Solution
The offered technology prevents the establishment of Cdiff in the GI tract, thus reducing the risk of recurring infections. The technology comprises a Lactobacillus sp bacterium which is a natural commensal in the human intestine; this organism has been engineered to surface-display a Cdiff protein responsible for GI tract attachment. Additional value propositions include a “kill switch” wherein the technology “self-destructs” when not required, and “oral vaccine” via potent immunogenicity of the surface-displayed Cdiff protein. The technology is orally delivered, rapidly establishes in the GI tract, and prevents CDI with high efficiency in rodent and piglet models of lethal disease.
The Opportunity
Treatment of CDIs in the United States represents a roughly $1B market. While the market slightly shrank during the pandemic, it recovered and is expected to grow by 6-7% each year. Treatment is currently largely via antibiotics. Alternate treatment regiments through microbiota transplantation are currently under evaluation. Because of the challenges of antibiotic resistance, new treatment modalities like the offered technology are needed.
Status
The technology has been successfully evaluated in lethal CDI animal models, and is well tolerated. Preparation of the agent is reproducible and ready to be scaled up. Evaluation of the clinical path forward is currently ongoing.
Meet the Team
Gayatri Vendantam PhD
College of Agriculture, Life & Environmental Sciences
Peter Nestler PhD
Tech Launch Arizona
Contact us today.
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