Houston, Texas, United States, Aug 27, 2026
FibroBiologics, Inc. has released the third batch of CYWC628 drug product and shipped it to Australia to support its ongoing Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs). The latest batch was manufactured in accordance with current Good Manufacturing Practices (cGMP) and successfully completed the required safety and quality testing, enabling its release for clinical use. The manufacturing milestone supports continued supply for clinical trial sites as FibroBiologics advances evaluation of its investigational allogeneic fibroblast cell-based therapy for wound healing. The company is conducting a prospective, multicenter, randomized study designed to evaluate the safety, tolerability and efficacy of CYWC628 in patients with refractory diabetic foot ulcers. FibroBiologics also said it anticipates reporting statistically significant interim data on primary outcomes during the second half of 2026, although the eventual clinical results remain subject to the ongoing trial.
Third CYWC628 Batch Supports Clinical Trial
The release of the third CYWC628 batch represents an important clinical manufacturing milestone for FibroBiologics as the company continues its Phase 1/2 development program. According to the company, the drug product was manufactured under cGMP requirements and passed all required safety and quality testing before being released for use in the clinical study. The batch has been shipped to Australia, ensuring participating clinical sites have drug product available to continue treating enrolled patients according to the study protocol. Maintaining a consistent supply of investigational product is an important operational component of clinical development, particularly for a multicenter randomized trial. FibroBiologics said the availability of the newly released batch will allow its clinical trial sites to continue the study while the company works toward upcoming interim analyses. The manufacturing update therefore connects the company’s CMC and quality activities directly with the ongoing clinical evaluation of CYWC628.
CYWC628 Targets Diabetic Foot Ulcer Healing
CYWC628 is an investigational, topically administered allogeneic fibroblast cell-based therapy being developed for wound healing. FibroBiologics reports that preclinical data suggest the therapy may accelerate wound healing compared with currently available treatments. The Phase 1/2 clinical trial is evaluating CYWC628 in patients with refractory diabetic foot ulcers, a difficult-to-treat complication associated with diabetes. The prospective, multicenter, randomized study includes treatment groups receiving standard of care plus either a low or high dose of CYWC628, alongside a standard-of-care control group. Treatment is planned for up to 12 weeks, with the study designed to generate information on the candidate’s safety, tolerability and efficacy. As an investigational therapy, CYWC628 has not yet been established as an approved treatment, and the company’s preclinical findings and expectations for clinical outcomes remain subject to confirmation through the ongoing trial. The study’s interim results are expected to provide additional information about the candidate’s performance and its potential role in diabetic wound management.
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cGMP Manufacturing Advances FibroBiologics Program
The latest batch release also highlights the importance of cGMP manufacturing and quality control in advancing cell-based therapies from development into clinical testing. Successful completion of required testing allowed FibroBiologics to release the third batch for clinical use, supporting continued evaluation of CYWC628 at Australian trial sites. The company, a clinical-stage biotechnology developer focused on fibroblast cells and fibroblast-derived materials, is developing therapies across several chronic disease areas, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics and cancer. For CYWC628, the immediate development focus remains the Phase 1/2 diabetic foot ulcer trial and the generation of clinical evidence needed to assess the therapy’s potential. FibroBiologics expects to report interim primary outcome data in the second half of 2026, according to the company. The third drug-product batch therefore represents both a manufacturing achievement and a practical step in maintaining clinical trial execution. Future clinical data will be important in determining whether CYWC628 can progress into later-stage development and potentially provide a new therapeutic approach for patients with difficult-to-heal diabetic foot ulcers.
Source: FibroBiologics press relese
