FibroBiologics Releases cGMP-Compliant CYWC628 Batch for Diabetic Foot Ulcer Trial
FibroBiologics released its first cGMP-compliant batch of investigational CYWC628 for a Phase 1/2 diabetic foot ulcer trial after passing all safety and quality tests. The company holds 270+ patents and is now poised to begin patient enrollment to assess safety, tolerability and preliminary efficacy in DFU patients.
1. Manufacturing Milestone Achieved
FibroBiologics has completed manufacturing and released the first cGMP batch of CYWC628 after passing all required safety and quality tests, meeting FDA current Good Manufacturing Practices standards and enabling clinical use.
2. Phase 1/2 Trial Overview
The Phase 1/2 trial will enroll patients with diabetic foot ulcers to assess safety, tolerability and preliminary efficacy of CYWC628, marking the first human study of the fibroblast-based therapy.
3. CYWC628 Therapy and Patent Portfolio
CYWC628 uses fibroblast-derived materials to promote wound healing in chronic DFUs, and is supported by the company’s 270+ issued and pending patents in cell therapy and tissue regeneration.
4. Next Steps and Enrollment Timeline
With the drug batch released, patient enrollment is set to begin soon, generating initial safety and efficacy data that will inform the future commercial and development strategy for CYWC628.