FibroBiologics (NASDAQ:FBLG), a clinical-stage biotechnology company, has released and shipped the third batch of its experimental drug product, CYWC628, to Australia to support an ongoing clinical trial for diabetic foot ulcers (DFUs).
The compant describes the investigational treatment as a topically applied allogeneic cell therapy that uses donor fibroblasts, a type of specialized connective tissue cell, to accelerate wound healing.
The batch was manufactured in accordance with current Good Manufacturing Practices (cGMP) and passed all mandatory safety and quality evaluations prior to its release for clinical use, it added.
The prospective, multicenter, randomized Phase 1/2 study evaluates the safety, tolerability, and efficacy of the treatment in patients suffering from refractory diabetic foot ulcers.
Participants in the trial receive up to 12 weeks of treatment using standard medical care combined with either a low or high dose of CYWC628, or standard care alone.
Pete O'Heeron, the founder and chief executive officer of FibroBiologics, stated that the shipment ensures clinical trial sites in Australia have the necessary supplies to proceed with the study.
O'Heeron noted that early progress in the trial has been encouraging, with the company expecting to report statistically significant interim data on primary outcomes in the second half of 2026.
Preclinical laboratory data indicate that CYWC628 has the potential to significantly accelerate wound healing compared to existing medical treatments.
Based in Houston, FibroBiologics focuses on developing treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials.
The company holds more than 270 issued and pending patents across multiple clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, longevity, and cancer.