BiomEdit Cleared for Field Safety Trials of Innovative Poultry Biologic
BiomEdit, Inc., a frontrunner in animal health biotechnology, has announced significant progress in the development of BE-101, its novel candidate aimed at mitigating mortality rates caused by necrotic enteritis (NE) in broiler chickens. The company has received a Finding of No Significant Impact (FONSI) from the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), paving the way for crucial field safety trials.
Regulatory Milestone Achieved
The USDA’s FONSI confirms that the environmental review of BE-101 indicated no adverse effects on the ecosystem. Following this assessment, BiomEdit can proceed with the final phase of evaluations. Once the company’s manufacturing partner, Diamond Animal Health, fulfills the USDA’s pre-license requirements, BE-101 will be shipped to field sites for testing, expected to commence in early Q1 2026.
“Receiving the FONSI letter is a critical regulatory achievement as we move towards providing a groundbreaking solution for poultry producers,” stated Aaron Schacht, CEO of BiomEdit. “Necrotic enteritis results in an estimated $6 billion in annual losses globally, yet poultry producers have limited access to effective non-antibiotic alternatives. BE-101 is poised to address this issue with a practical and scalable biologic solution.”
About BE-101
BE-101 is an advanced probiotic vectored antibody (pvAb™) biologic specifically engineered to neutralize the toxins produced by Clostridium perfringens, which is a leading cause of NE-related mortality and productivity decline in poultry. In commercial-like challenge trials, BE-101 has shown promising results, including significant reductions in mortality rates, improved feed conversion, and enhanced bird weight gain.
Development Progress
BiomEdit’s development program for BE-101 is on target for conditional licensure by Q4 2026. Recent achievements include:
- Successful completion of engineering batches necessary for commercial production.
- Initiation of pre-license serial batch manufacturing, currently operating at the halfway mark.
- Ongoing USDA assessment of the field safety study protocol, with anticipations for feedback before the year concludes to enable trial initiation early in 2026.
The completion of pre-licensing serial manufacture and field safety trials are the last steps required for conditional licensure. Once approved, BE-101 will be BiomEdit’s inaugural product to launch since the company’s inception in 2022.
Future of Poultry Health
Upon successful licensure, BE-101 will be marketed under the brand name Optavant™, marking the introduction of the first non-antibiotic biologic specifically formulated to combat necrotic enteritis while promoting enhanced flock health and production efficiency.
About BiomEdit
Founded in 2022, BiomEdit, Inc is an innovative animal health microbial biotechnology company focused on harnessing the capabilities of the microbiome and synthetic biology to create next-generation solutions for livestock and pet health. With support from leading investors such as Anterra Capital, Viking Global, Nutreco, AgriZeroNZ, Elevate, and Betagro Ventures, the company is well-positioned for ongoing advancements in animal health.
For more information, visit www.biomedit.com.
Source: BiomEdit
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