other material
confidence high
sentiment positive
materiality 0.60
FibroBiologics pipeline update: CYWC628 pre-clinical data shows improved wound healing vs Grafix
FibroBiologics, Inc.
- CYWC628 multiple administration study: 69.3% wound area reduction at day 12 vs 47.13% for Grafix (p<0.05).
- Planning Phase 1/2 clinical trial in Australia for diabetic foot ulcers in 2025, results expected Q3 2025.
- FDA IND clearance for CybroCell Phase 1/2 trial for degenerative disc disease, conditional on master cell bank.
- Expect to complete remaining CYWC628 pre-clinical studies (toxicity, dose titration) in Q3 2024.
- Manufacturing: planning CDMO transfer; master cell bank, working cell bank, and drug product by end of 2024.