FibroBiologics Completes First CGMP Batch of CYWC628 for Diabetic Foot Ulcer Trial
FibroBiologics completed manufacturing of the inaugural CYWC628 fibroblast spheroid therapy batch under FDA CGMP standards, marking the first large-scale spheroid product production for therapeutic use. The CGMP-compliant batch targeting diabetic foot ulcers will undergo safety and quality testing ahead of first-in-human Phase 1/2 trials slated for H1 2026.
1. Manufacturing Milestone
FibroBiologics has successfully produced its first large-scale batch of CYWC628 fibroblast-based spheroids under FDA Good Manufacturing Practice guidelines. This achievement represents the inaugural CGMP production run for a spheroid therapeutic candidate, laying the foundation for clinical development.
2. Clinical Trial Plans
The manufactured CYWC628 batch will be released after passing all mandated safety and quality assessments and is planned for use in first-in-human Phase 1/2 trials in diabetic foot ulcer patients. Enrollment is expected to begin in the first half of 2026, testing safety, dosing and preliminary efficacy.
3. Therapeutic Background and Company Pipeline
CYWC628 addresses a significant unmet need in diabetic foot ulcer care by leveraging fibroblast spheroids for tissue regeneration. FibroBiologics, with over 270 patents issued or pending, is advancing this candidate as part of a broader pipeline targeting chronic diseases through fibroblast-derived therapies.