AGC Biologics to develop and manufacture Flen Health enzyme therapy for diabetic foot ulcers
- AGC Biologics will carry out process development and GMP manufacturing for recombinant lactoperoxidase and glucose oxidase at its Heidelberg site.
- The work is intended to support Flen Health’s planned IND application and a Phase II clinical trial in the United States.
- The collaboration moved from a feasibility program started in July 2025 to full process development, scale-up and GMP manufacturing.
- AGC plans to produce the recombinant enzymes at 100‑liter and 1,000‑liter scales after technology transfer and analytical method implementation.
Agreement scope
AGC Biologics will provide process development and GMP manufacturing services for recombinant lactoperoxidase and glucose oxidase at its Heidelberg site to support Flen Health’s next‑generation therapy for diabetic foot ulcers.
Clinical support
The activities are intended to support Flen Health’s planned Investigational New Drug (IND) application and a Phase II clinical trial in the United States.
Program progress and manufacturing
The collaboration began as a feasibility program in July 2025. AGC Biologics has completed technology transfer for the enzyme manufacturing processes, developed cultivation and purification processes and implemented analytical methods; the agreement advances the work to process development, scale‑up and GMP manufacturing at 100‑liter and 1,000‑liter scales.
Context
Flen Health’s therapy builds on Flaminal® and targets diabetic foot ulcers, an area of unmet need: in 2024 roughly 589 million adults had diabetes and more than one in five people with diabetes are estimated to be at risk of developing a diabetic foot ulcer. AGC positions the work within its medium‑term AGC plus‑2026 plan to contribute to well‑being through its Life Science CDMO services.
Source: AGC