FibroBiologics Advances CYWC628 Phase 1/2 Trial

• FibroBiologics, Inc. has completed onboarding clinical sites for its Phase 1/2 trial evaluating CYWC628 for refractory diabetic foot ulcers.

• The study will assess safety, tolerability, and efficacy of the therapy, with Southern Star Research acting as the CRO managing all aspects of the clinical trial.

FibroBiologics, Inc. has completed onboarding clinical sites for its Phase 1/2 clinical trial evaluating CYWC628, an investigational therapy for the treatment of refractory diabetic foot ulcers (DFUs). The prospective, multicenter, open-label study will assess the safety, tolerability, and efficacy of the company’s topically administered allogeneic fibroblast spheroid-based therapy.

Participants in the study will receive up to 12 weeks of treatment with either standard of care combined with a low or high dose of CYWC628, or standard of care alone. FibroBiologics confirmed that clinical site onboarding has been completed in accordance with the study protocol, with the option to activate additional sites if needed to support recruitment targets.

The trial will evaluate wound healing outcomes, durability of response, and safety parameters through clinical observation, testing, and imaging assessments. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints.

Southern Star Research, a full-service Australian CRO with coverage across the Asia-Pacific region, is managing all aspects of the CYWC628 clinical trial from start to finish.

“The CYWC628 program is an excellent fit for Australia’s ecosystem and Southern Star Research’s expertise in complex early-phase trials.”

Lloyd Prescott, CEO of Southern Star Research

FibroBiologics focuses on developing therapies using fibroblasts and fibroblast-derived materials to address chronic diseases. The company stated that the CYWC628 trial aims to generate clinical data that could help define the role of fibroblast spheroid-based therapies in the treatment of refractory diabetic foot ulcers.