Key Takeaways:
- BiomEdit has launched a pivotal field safety trial for BE-101, its lead poultry biologic.
- The study is one of two final regulatory requirements before potential conditional licensure by USDA CVB.
- BE-101 targets necrotic enteritis (NE), a major cause of mortality in broiler chickens.
- Conditional licensure is anticipated in Q3 2026, subject to regulatory review.
- Commercial launch readiness is planned for early Q4 2026.
BiomEdit Advances Toward Conditional Licensure for BE-101
BiomEdit has initiated a pivotal field safety trial for BE-101, a non-antibiotic biologic designed to prevent mortality associated with necrotic enteritis (NE) in broiler chickens. The trial represents one of the two remaining regulatory requirements prior to potential conditional licensure by the U.S. Department of Agriculture’s Center for Veterinary Biologics (USDA CVB).
Two of the three required field safety sites began this month at commercial broiler production complexes. The trials are evaluating product from pre-licensing serial manufacturing batches. Upon completion of the field safety study, review of the final report by USDA CVB, and successful testing of product from pre-licensing serial batches, BiomEdit expects conditional licensure in the third quarter of 2026, assuming typical regulatory timelines. Commercial launch readiness is aligned for early Q4 2026.
Targeting Necrotic Enteritis with BiomEdit's Novel Approach
BE-101 is described as a probiotic vectored antibody (pvAb™) biologic engineered to neutralize toxins produced by Clostridium perfringens, a primary cause of NE-related mortality and production losses. Necrotic enteritis is considered one of the most economically significant diseases in broiler production, with global losses estimated at approximately $6 billion annually.
Recent findings published in npj Biofilms and Microbiomes reported statistically significant improvements in feed conversion and body weight gain in a commercial-like study under sub-clinical NE challenge conditions. According to the study, birds receiving BE-101 achieved a 6- to 7-point improvement in feed conversion ratio at key time points, along with increased finished weight and reduced NE mortality compared to challenged controls.
“As we continue to meet key milestones on the path toward conditional licensure, we're focused on the day we can bring this non-antibiotic solution to producers facing a disease where new solutions are needed,” said Aaron Schacht, CEO of BiomEdit. “Working directly with poultry producers during these field safety trials provides a real-world window into how the product performs on-farm. We're encouraged by the engagement and the opportunity to deliver a practical tool that supports both flock health and production performance.”
