FibroBiologics Inc. (NASDAQ:FBLG) on Wednesday announced that it has enrolled and dosed the first patients in its Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs).
FibroBiologics Does First Patients In CYWC628 Trial
FibroBiologics said it has dosed the first patients in the CYWC628 Phase 1/2 clinical trial.
The CYWC628 fibroblast-based therapy targets diabetic foot ulcers, a condition that affects millions of patients worldwide and currently lacks effective long-term treatment solutions.
A diabetic foot ulcer is an open sore, typically on the foot sole, affecting up to 15% of diabetics due to nerve damage (neuropathy) and poor circulation.
The company said its trial is designed to enroll up to 120 patients and will evaluate the safety, tolerability, and efficacy of CYWC628, FibroBiologics’ investigational topically administered allogeneic fibroblast-spheroid cell-based therapy, compared to standard of care (SoC) alone. Participants will receive up to 12 weeks of treatment using either SoC plus a low or high dose of CYWC628, or SoC alone.
The multicenter, randomized study is being conducted across multiple sites in Australia following receipt of both public and private Human Research Ethics Committee (HREC) approvals.
The trial will assess wound healing outcomes and safety parameters through regular clinical and imaging evaluations. An interim analysis will be conducted after participants complete six weeks of treatment to assess primary safety and efficacy endpoints.
Management Commentary
“This trial represents a meaningful opportunity to demonstrate what fibroblast-spheroid-based therapies can do for patients with some of the most difficult-to-treat chronic wounds,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics.
“The data we generate from this study will be foundational, not only for CYWC628, but for our broader understanding of how fibroblast-spheroid cell therapy can be applied across chronic disease indications,” he added.
Background
FibroBiologics is a clinical-stage biotechnology company focused on developing and commercializing fibroblast cell-based therapies for chronic diseases.
In May, the company said that the interim results from the study CYWC628 are expected in the third quarter of 2026, with complete and primary safety and efficacy results reported by the end of 2026.
In April, FibroBiologics raised $3 million via 2.27 million shares and warrants to purchase up to 2.272 million shares at a combined price of $1.32. The Warrants have an exercise price of $1.32 per share.
FBLG Price Action: FibroBiologics shares closed at $1.05 on Tuesday. The stock is trading near its 52-week low of $0.95, according to Benzinga Pro data.
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