HOUSTON, June 16, 2026
FibroBiologics announced that the first patients have been dosed in its ongoing Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs), marking a significant milestone in the company’s regenerative medicine development program. Initial patient dosing took place during the first week of June, advancing CYWC628 from preclinical and manufacturing stages into active clinical evaluation. The investigational therapy is designed to address the underlying biological deficiencies associated with chronic wounds using allogeneic fibroblast-based cell therapy, with the goal of accelerating healing and improving outcomes for patients suffering from difficult-to-treat diabetic foot ulcers.
CYWC628 Targets the Root Causes of Chronic Wound Healing Failure
CYWC628 is a topically administered fibroblast cell-based therapy developed to restore the natural wound-healing processes often impaired in diabetic patients. Fibroblasts play a critical role in tissue repair by producing growth factors, extracellular matrix components, and structural support necessary for wound closure. According to preclinical studies, CYWC628 demonstrated the potential to significantly enhance wound healing compared with currently available treatment options. The ongoing multicenter, randomized Phase 1/2 study is evaluating the safety, tolerability, and efficacy of low-dose and high-dose CYWC628 in combination with standard of care, compared with standard treatment alone. Patients enrolled in the trial may receive treatment for up to 12 weeks as investigators assess the therapy’s clinical impact on refractory diabetic foot ulcers.
Manufacturing Progress Supports Ongoing Clinical Development
Alongside clinical advancement, FibroBiologics continues to strengthen its manufacturing capabilities to ensure a reliable supply of CYWC628 for current and future studies. The company announced that drug product from its second Good Manufacturing Practice (GMP) production run has successfully been released and is scheduled for shipment to Australia to support ongoing clinical activities. In addition, FibroBiologics has completed the first two manufacturing batches within its third GMP production campaign, demonstrating continued scalability and reproducibility of its fibroblast manufacturing platform. Company leadership emphasized that consistent GMP production is a critical component in ensuring product quality, patient safety, and future commercial readiness as the development program progresses.
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Fibroblast Platform Expands Opportunities in Regenerative Medicine
Diabetic foot ulcers remain one of the most serious complications of diabetes, often leading to prolonged hospitalizations, infections, amputations, and significant healthcare costs worldwide. By leveraging the regenerative capabilities of fibroblast cells, FibroBiologics aims to provide a novel therapeutic approach that goes beyond symptom management and promotes true tissue repair. The company believes the successful initiation of patient dosing, combined with continued manufacturing achievements, validates both its clinical strategy and proprietary fibroblast platform technology. Beyond wound healing, FibroBiologics maintains a broad pipeline targeting multiple therapeutic areas, including multiple sclerosis, psoriasis, orthopedic disorders, disc degeneration, cancer, and longevity-focused applications. As clinical evaluation of CYWC628 advances, the company continues to position fibroblast-based therapies as a next-generation approach for treating chronic diseases and regenerative medicine challenges.
Source: FibroBiologics press release
