USDA grants conditional license to engineered bacterial biologic for necrotic enteritis in poultry

The US Department of Agriculture's Center for Veterinary Biologics (USDA CVB) has granted a conditional license to an engineered bacterial biologic designed to reduce necrotic enteritis (NE)-associated mortality in broiler chickens. The company that developed it, BiomEdit, says it believes the product is the first genetically engineered probiotic biologic licensed for use in any animal species worldwide.¹

The product's full name is Clostridium Perfringens Alpha Toxin and NetB Antibody Fragment, Live Limosilactobacillus Vector (CPerf LLV). It uses a live probiotic strain engineered to target toxins produced by Clostridium perfringens, a main driver of NE-related disease, deaths, and productivity losses in poultry. The company describes it as a non-antibiotic approach that gives producers an option for NE beyond antibiotics.¹

According to the release, the license was granted "based on the demonstration of a reasonable expectation of efficacy in terms of reduced NE-associated mortality in broiler chickens challenged with Clostridium perfringens." The product's label indication covers passive immunity of healthy chicks against C perfringens. The duration of that immunity has not been determined, and efficacy and potency have not been fully demonstrated.¹

What the data show

The pivotal efficacy study reviewed by USDA CVB found a 48.7% reduction in NE-associated mortality. Mortality was 13.1% in challenged control birds and 6.6% in birds that received CPerf LLV.¹

The company also pointed to separately published results in npj Biofilms and Microbiomes. In a controlled study of subclinical NE, probiotic-delivered nanobodies targeting alpha toxin and NetB improved broiler weight gain and feed conversion, outperforming both prophylactic antibiotics and the parent probiotic strains. According to the release, the USDA did not review those published data as part of the conditional licensure process.¹

NE carries a heavy economic burden. A widely cited industry analysis estimates the disease costs the global broiler industry up to $6 billion each year in production losses and control measures.¹

How conditional licensure works

USDA conditional licensure allows earlier market access for products that show safety and a reasonable expectation of efficacy. The pathway is meant to address animal diseases with limited treatment options while more data are collected for full licensure.¹ BiomEdit says it will keep working toward a full license for CPerf LLV, which is expected to be branded Optavant at that point. The conditional license is held by Diamond Animal Health, BiomEdit's contract development and manufacturing partner.¹

"USDA conditional licensure of CPerf LLV is a defining moment for BiomEdit and for animal health," Aaron Schacht, CEO of BiomEdit, said in the release.¹ "More importantly, it validates our belief that programmable biologics can fundamentally expand what is possible in animal health."

Field evaluations underway

BiomEdit has started a commercial evaluation program with 3 major US poultry producers, with the product expected to be used in more than 35 million broilers. The program lets producers see how CPerf LLV performs in their own production systems.¹

"We have been encouraged by the level of interest from poultry producers as we move from regulatory approval into real-world use," Andrew Carlson, BiomEdit's chief commercial officer, said in the release.¹ "These evaluation trials give producers the opportunity to see how CPerf LLV performs in their systems, which is especially important for a novel biologic technology. Our goal is to provide a practical, scalable, non-antibiotic tool for a disease where solutions are needed."

Reference

1. BiomEdit's first-of-its-kind engineered bacterial biologic for poultry receives conditional licensure from USDA. News release. BiomEdit. September 29, 2026. Accessed October 6, 2026. https://www.prnewswire.com/news-releases/biomedits-first-of-its-kind-engineered-bacterial-biologic-for-poultry-receives-conditional-licensure-from-usda-302892365.html