ZIVO Bioscience, Inc. announced the receipt of a letter from the U.S. Department of Agriculture's (USDA) Center for Veterinary Biologics (CVB) affirming that the agency has claimed jurisdiction for reviewing the Company's novel immune-modulating biologic for treating coccidiosis in broiler chickens. Coccidiosis is a parasitic disease of the intestinal tract caused by coccidian protozoa and is one of the largest health and animal welfare problems facing poultry flocks. The global poultry industry spends more than $1.5 billion annually on coccidiosis control, primarily using decades-old compounds that face growing anticoccidial drug resistance.

Coccidiosis is a common disease for chickens, especially among young chicks, and can be fatal or result in compromised digestion. ZIVO is developing a product candidate for use in poultry feed that is designed to boost immune response, allowing birds to effectively combat coccidiosis and reduce the negative effects of the disease without the use antimicrobial compounds. ZIVO's biologic features a first-in-class novel mechanism of action (MOA) that differentiates it from existing products by qualifying for the regulatory approval process of the CVB.

Following a comprehensive review of data from several of ZIVO's efficacy studies, MOA studies and manufacturing processes, the CVB verified ZIVO's product is of biological origin and functions through an immune-modulating MOA that has no direct antimicrobial activity, and therefore is subject to their regulatory review. While other products for the control of coccidiosis delivered in feed are regulated by the U.S. FDA's Center for Veterinary Medicine, CVB's jurisdictional announcement removes regulatory ambiguity while providing a path for a comprehensive review.