FibroBiologics has completed clinical site onboarding for its Phase 1/2 trial of CYWC628, a fibroblast spheroid-based therapy for refractory diabetic foot ulcers, with interim data expected during the study.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
FibroBiologics has completed onboarding of clinical trial sites for its Phase 1/2 study evaluating CYWC628, an investigational fibroblast-based therapy for the treatment of refractory diabetic foot ulcers (DFUs). The milestone marks a key operational step as the company prepares to initiate patient enrollment for the trial.
The study is a prospective, multicenter, open-label clinical trial designed to assess the safety, tolerability, and efficacy of CYWC628 when used alongside standard of care (SoC) in patients with difficult-to-treat diabetic foot ulcers.
CYWC628 is a topically administered allogeneic fibroblast spheroid-based therapy intended to promote wound healing. According to FibroBiologics, preclinical findings suggest the therapy may accelerate wound closure compared with currently available treatments.
Participants in the trial will receive up to 12 weeks of treatment and will be assigned to one of three groups: SoC plus a low dose of CYWC628, SoC plus a high dose of CYWC628, or SoC alone. The study will monitor wound healing outcomes, durability of response, and safety parameters through clinical observation, laboratory testing, and imaging assessments.
Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, said the trial will generate key early-stage clinical data on the therapy’s performance in patients with chronic wounds. An interim analysis is planned after a predefined number of participants complete six weeks of treatment, allowing researchers to evaluate initial safety and efficacy endpoints.
Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics, noted that completing site onboarding represents an important step toward trial initiation. He added that the company aims to generate data that could help define the role of fibroblast spheroid-based therapies in the future management of chronic wounds, particularly in patients with refractory DFUs.
The trial is being managed by Southern Star Research, an Australian full-service contract research organization with expertise in early-phase clinical development across the Asia-Pacific region. The CRO will oversee all operational aspects of the study from initiation through completion.
CYWC628 is part of FibroBiologics’ broader platform focused on developing fibroblast-based therapeutics for chronic diseases and regenerative medicine applications. The company’s pipeline explores the potential of fibroblasts and fibroblast-derived materials to repair damaged tissue and restore biological function.
Diabetic foot ulcers are a common complication of diabetes and represent a major cause of hospitalization and lower-limb amputation worldwide. Many ulcers fail to heal with current treatments, highlighting the need for new regenerative therapies that can improve wound closure and long-term outcomes.
Reference
FibroBiologics Completes Site Onboarding for Phase 1/2 Clinical Trial for CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers, 05 March 2026, FibroBiologics Completes Site Onboarding for Phase 1/2 Clinical Trial for CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers :: FibroBiologics, Inc. (FBLG)
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Nikita Jha BPharm
She is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.