FibroBiologics Receives HREC Approval for Phase 1/2 Clinical Trial for CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers
FibroBiologics, Inc. recently announced it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers (DFU). This approval enables enrollment of 120 patients at 10 sites across Australia. With the HREC approval and Therapeutics Goods Administration (TGA) filing now complete, FibroBiologics has secured all necessary regulatory approvals and submitted all required filings to proceed with the clinical trial.
Southern Star Research, a leading full-service Australian CRO with APAC coverage, will manage all aspects of the CYWC628 trial from start to finish. “We are honored to continue our partnership with FibroBiologics whose leadership in cell therapy and regenerative medicine truly inspires us.” said Lloyd Prescott, CEO of Southern Star Research.
The approved clinical trial is a prospective, multicenter, randomized study designed to evaluate the safety, tolerability, and efficacy of FibroBiologics’ investigational topically administered allogeneic fibroblast cell-based therapy, CYWC628, for the treatment of refractory DFU. Participants will receive up to 12 weeks of treatment using either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone.
The trial will assess wound healing outcomes, efficacy of response, and safety parameters through regular clinical and imaging evaluations. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints.
“We’re excited to receive HREC approvals for our Phase 1/2 trial in refractory diabetic foot ulcers,” said Pete O’Heeron, Founder and CEO of FibroBiologics. “This is an important milestone. It moves our fibroblast-based platform into real-world clinical testing. What we learn from this study could potentially help unlock a new class of cell therapies for chronic wounds—an area where patients have been underserved for far too long. This is exactly the kind of long-term, high-impact work that drives our mission.”
In addition to confirming safety and therapeutic potential, the study is expected to provide key clinical data supporting CYWC628 as a novel, fibroblast-based cell therapy aimed at addressing a significant unmet need in chronic wound management. For more information, please visit FibroBiologics’ website or email FibroBiologics at: info@fibrobiologics.com.
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