FibroBiologics has enrolled and dosed the first patients in a Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers, according to the company.
The prospective, multicenter, randomized study is being conducted at multiple sites in Australia following receipt of public and private Human Research Ethics Committee approvals and completion of the required Therapeutics Goods Administration filing. The trial is designed to enroll up to 120 patients to evaluate the safety, tolerability and efficacy of topically administered allogeneic fibroblast-spheroid cell therapy compared with standard of care alone.
Participants may receive up to 12 weeks of treatment with standard of care plus a low or high dose of CYWC628, or standard of care only.
An interim analysis is planned after six weeks to assess primary safety and efficacy endpoints, with wound healing outcomes and safety monitored through clinical and imaging evaluations.
The company claims preclinical data suggest CYWC628 may significantly accelerate wound healing and expects the study to generate key clinical data to support further development.
