FibroBiologics, Inc. (Nasdaq: FBLG) has partnered with Southern Star Research, an Australian clinical research organization (CRO), to conduct a Phase 1/2 clinical trial of its product candidate, CYWC628, for the treatment of diabetic foot ulcers. The collaboration aims to leverage Australia's favorable clinical trial environment to advance FibroBiologics' fibroblast cell-based therapy.
Clinical Trial Plans
Southern Star Research will provide CRO services, including preparatory work, for the planned Phase 1/2 clinical trial of CYWC628. This trial represents a significant step forward in FibroBiologics' clinical development program, as it seeks to address the unmet needs in treating diabetic foot ulcers.
Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics, stated, "This engagement is an important step forward in creating the infrastructure for FibroBiologics to conduct clinical trials in Australia, including a planned Phase 1/2 clinical trial for CYWC628 to treat diabetic foot ulcers...Australia offers an attractive destination for clinical trials due to its high-quality clinical trial infrastructure, regulatory environment and R&D incentives."
CYWC628: A Novel Approach to Wound Healing
CYWC628 is an allogeneic fibroblast cell-based therapy designed to promote and accelerate wound healing, specifically targeting diabetic foot ulcers. These ulcers pose a significant clinical challenge, often leading to infections, hospitalization, amputation, and even death. CYWC628 enhances the ability of fibroblasts to survive and function in the wound environment, improving the body’s natural repair mechanisms and potentially offering a more effective treatment for chronic wounds.
The therapy aims to improve the natural repair mechanisms of the body, offering a potentially more effective treatment for these chronic wounds. The approach uses allogeneic fibroblast cells to enhance wound healing, addressing the difficulties in treating diabetic foot ulcers.
Strategic Rationale
The partnership with Southern Star Research allows FibroBiologics to tap into Australia's robust clinical trial infrastructure and benefit from R&D incentives. David Lloyd, Managing Director of Southern Star Research, expressed enthusiasm for the collaboration, stating, "We are delighted to partner with FibroBiologics, a pioneer in the field of fibroblast cell-based therapies, to support their clinical development in Australia."
About FibroBiologics
FibroBiologics is a clinical-stage biotechnology company focused on developing treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. The company holds over 160 patents and patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer.
