HOUSTON, March 5, 2026 — Leads & Copy — FibroBiologics, Inc. (Nasdaq: FBLG), a clinical-stage biotechnology company, has completed onboarding clinical sites for its Phase 1/2 clinical trial of CYWC628, a treatment for refractory diabetic foot ulcers (DFUs).
The trial will evaluate the safety and efficacy of CYWC628, a topically administered allogeneic fibroblast spheroid-based therapy. The study is a prospective, multicenter, open-label trial where participants will receive up to 12 weeks of treatment. Treatment options include standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone.
FibroBiologics has completed site onboarding per the clinical trial protocol and may activate additional sites to meet recruitment goals.
Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, said the trial will assess wound healing outcomes, durability of response, and safety through clinical observation, testing, and imaging. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints.
Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics, noted the completion of site onboarding as a critical step toward demonstrating the potential of fibroblast spheroid-based therapies for DFU treatment. He added that the company is focused on disciplined execution and looks forward to generating data to inform the therapy’s role in chronic wound care.
Southern Star Research, an Australian CRO, is managing all aspects of the CYWC628 trial. Lloyd Prescott, CEO of Southern Star Research, stated that the CYWC628 program is an excellent fit for Australia’s ecosystem and Southern Star Research’s expertise in complex early-phase trials.
CYWC628 is an investigational topically administered allogeneic fibroblast cell-based therapy for wound healing. Preclinical data suggest CYWC628 may significantly accelerate wound healing compared to currently available treatments.
FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer.
Southern Star Research supports trials across a range of therapeutic areas and phases, with a strong focus on quality, collaboration, and scientific excellence.
Source: FibroBiologics
