FibroBiologics has dosed first patients in its Phase 1/2 CYWC628 diabetic foot ulcer trial enrolling up to 120 participants at Australian sites after HREC approval and TGA filing. The study will assess safety, tolerability and efficacy of low and high CYWC628 doses versus standard care over 12 weeks.
FibroBiologics has enrolled and dosed the first patients in its Phase 1/2 trial of CYWC628 for diabetic foot ulcers, a prospective, randomized study spanning multiple Australian centers. The protocol, approved by public and private Human Research Ethics Committees and cleared by the Therapeutics Goods Administration, plans to enroll up to 120 participants.
Participants will receive standard-of-care treatment plus either a low or high dose of topically administered allogeneic fibroblast-spheroid therapy or standard-of-care alone for up to 12 weeks. The multicenter design includes randomized assignment to three arms to evaluate dose-dependent effects on wound healing.
The trial will assess safety, tolerability and efficacy through clinical and imaging evaluations, with an interim analysis after six weeks to review primary safety and efficacy endpoints. Data will inform future development of CYWC628 as a novel cell-based therapy for chronic wound management.
