FibroBiologics completes manufacturing of drug for diabetic foot ulcer trial

FibroBiologics Inc. (NASDAQ: FBLG) announced the completion of manufacturing for its CYWC628 drug product, which will support upcoming clinical trials for diabetic foot ulcers. The drug product was manufactured according to FDA Good Manufacturing Practices and will be released after passing required safety and quality testing.

The CYWC628 therapy uses fibroblast-based spheroids to target diabetic foot ulcers. Pete O'Heeron, founder and chief executive officer of FibroBiologics, stated that CYWC628 represents the first fibroblast-based spheroid therapeutic candidate and the first large-scale CGMP manufacturing of a spheroid product for therapeutic use.

The Houston-based biotechnology company plans to initiate a Phase 1/2 clinical trial using CYWC628 in diabetic foot ulcer patients in the first half of 2026, according to the company's statement.

FibroBiologics holds more than 270 issued and pending patents across various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. The company focuses on developing therapeutics using fibroblasts and fibroblast-derived materials for chronic diseases.

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