Houston, Texas — November 20, 2025 — Leads & Copy — FibroBiologics, Inc. (Nasdaq: FBLG) has received approval in Australia to begin Phase 1/2 clinical trials for its CYWC628 treatment for refractory diabetic foot ulcers (DFU). The company received approval from both public and private Human Research Ethics Committees (HREC) in Australia.
The approval allows FibroBiologics to enroll 120 patients across 10 sites in Australia. The company has completed all necessary regulatory approvals and filed all required documentation with the Therapeutics Goods Administration (TGA) to proceed with the trial. Southern Star Research, an Australian CRO covering the APAC region, will manage the CYWC628 trial.
The trial is a prospective, multicenter, randomized study to evaluate the safety, tolerability, and efficacy of CYWC628, a topically administered allogeneic fibroblast cell-based therapy, for treating refractory DFU. Participants will undergo a 12-week treatment period, receiving either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone.
The trial will assess wound healing, efficacy of response, and safety through clinical and imaging evaluations. An interim analysis will be conducted after a number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints.
Pete O’Heeron, Founder and CEO of FibroBiologics, expressed excitement over the HREC approvals, stating that the trial moves their fibroblast-based platform into real-world clinical testing. The study’s findings could potentially lead to a new class of cell therapies for chronic wounds.
The clinical data from the study is expected to support CYWC628 as a novel cell therapy for chronic wound management.
Nic Johnson from Russo Partners is available for investor relations inquiries at (212) 845-4242 or via email at fibrobiologicsIR@russopr.com. Liz Phillips from Russo Partners can be reached for media inquiries at (347) 956-7697 or Elizabeth.phillips@russopartnersllc.com.
Source: FibroBiologics, Inc.
