Key Takeaways
- BiomEdit has received a Finding of No Significant Impact (FONSI) from USDA APHIS for BE-101, its lead necrotic enteritis prevention candidate.
- The decision allows BE-101 to proceed toward field safety trials, expected to begin in early Q1 2026.
- BE-101 targets Clostridium perfringens toxins through an engineered probiotic vectored antibody (pvAb™) approach.
- Several development milestones have been completed, with conditional licensure targeted for Q4 2026.
- Upon full approval, BE-101 will be commercialized as Optavant™, the first non-antibiotic biologic specifically developed to combat NE in broilers.
BiomEdit Receives USDA FONSI for Lead Poultry Biologic BE-101
BiomEdit announced that it has received a Finding of No Significant Impact (FONSI) from the USDA’s Animal and Plant Health Inspection Service for BE-101, its lead biologic candidate aimed at preventing mortality caused by necrotic enteritis (NE) in broiler chickens. The FONSI follows USDA’s environmental and risk assessment and marks a significant advancement as the program moves into its final evaluation phase.
NE remains one of the costliest poultry diseases worldwide, contributing to an estimated $6 billion in losses annually. Producers have limited non-antibiotic solutions, positioning BE-101 as a potential new tool for improving flock health and productivity.
BiomEdit Moves Toward Field Trials After USDA Clearance
With the FONSI in place, BE-101 is cleared to proceed to field safety trials once BiomEdit’s manufacturing partner, Diamond Animal Health, completes USDA-required pre-license serials. Field testing is targeted to begin in early Q1 2026.
“The FONSI letter represents another key regulatory milestone as we work to deliver a first-of-its-kind solution for poultry producers,” said Aaron Schacht, CEO of BiomEdit.
BE-101 is designed as an engineered probiotic vectored antibody (pvAb™) biologic that neutralizes Clostridium perfringens toxins—primary drivers of NE-related mortality and reduced bird performance. In challenge studies, the product has shown improvements in mortality rates, feed conversion efficiency and weight gain.
Reports Strong Progress Toward Conditional Licensure
BiomEdit confirmed that the BE-101 program remains on track for conditional licensure by Q4 2026, with multiple development milestones recently completed, including:
- Successful engineering batches supporting manufacturing readiness
- Ongoing manufacture of pre-license serial batches, now at the halfway point
- Active USDA review of the field safety study protocol, with feedback expected before year-end
The remaining steps toward conditional licensure include completion of pre-licensing serial manufacture, serial testing and field safety trials.
BiomEdit Prepares BE-101 for Commercial Launch as Optavant™
Upon full licensure, BE-101 will be commercialized under the brand name Optavant™, becoming the first non-antibiotic biologic developed specifically for necrotic enteritis prevention in broilers. It will also be the first BiomEdit product to reach commercial launch since the company’s founding in 2022.
