HOUSTON, July 31, 2026
FibroBiologics, Inc. has begun dosing patients in its Phase 1/2 clinical trial evaluating CYWC628, a fibroblast-based spheroid product candidate for the treatment of diabetic foot ulcers (DFUs), marking an important clinical milestone for the company’s regenerative medicine pipeline. FibroBiologics expects to report interim results from the study during the second half of 2026, followed by primary safety and efficacy results by the end of the year. The Houston-based clinical-stage biotechnology company disclosed the progress alongside its second-quarter 2026 financial results and broader corporate update. FibroBiologics is developing therapeutics using fibroblast cells and fibroblast-derived materials across chronic diseases, including wound healing, psoriasis, multiple sclerosis and degenerative disc disease.
CYWC628 Enters Phase 1/2 Evaluation in Diabetic Foot Ulcers
The initiation of patient dosing moves CYWC628 into clinical evaluation for diabetic foot ulcers, establishing an important test of FibroBiologics’ fibroblast-based therapeutic approach in patients. The company has also completed manufacturing of three batches of CYWC628 drug product in accordance with FDA current Good Manufacturing Practices (cGMP). Two batches have been released, while the third is expected to be released after successfully completing required safety and quality testing. FibroBiologics anticipates reporting interim clinical results in the second half of 2026 and completing and disclosing primary safety and efficacy results by year-end. The trial represents a significant step for the company as it seeks to translate its fibroblast technology into potential regenerative treatments for chronic wounds. FibroBiologics also recently received notice of allowance from the U.S. Patent and Trademark Office for intellectual property covering methods designed to treat and accelerate wound healing through topical administration of three-dimensional fibroblast spheroids, alone or together with fibroblast-derived materials.
Fibroblast Research Expands Across Regenerative Medicine
Beyond CYWC628, FibroBiologics reported preclinical findings suggesting that topically administered human dermal fibroblast spheroids may modify the biological environment of burn wounds. The research indicated potential effects involving reduction of harmful inflammation, changes in immune cell behavior and decreased markers associated with scar-forming activity within eight days of injury. These findings remain preclinical but provide additional scientific support for investigating fibroblast-based approaches across wound-healing applications. The company is simultaneously progressing several additional therapeutic programs. FibroBiologics anticipates IND clearance for CYPS317, its fibroblast spheroid candidate for psoriasis, in the fourth quarter of 2026. It also plans to submit an IND application to the FDA during the fourth quarter for CYMS101, a fibroblast spheroid candidate being developed for multiple sclerosis. In degenerative disc disease, the company plans to amend an existing IND clearance to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids originating from the CYWC628 master cell bank.
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Clinical Progress Supported by Manufacturing and Financing
FibroBiologics is supporting its expanding clinical pipeline with financing and continued investment in research and manufacturing. During the period, the company completed a $9 million private placement, consisting of $3 million upfront and up to approximately $6 million in potential additional gross proceeds from warrant exercises, while also closing a $3 million public offering. For the second quarter ended June 30, 2026, research and development expenses were approximately $1.7 million, compared with approximately $2 million during the corresponding period in 2025. The company reported a quarterly net loss of approximately $4.1 million and held approximately $3.5 million in cash and cash equivalents as of June 30. FibroBiologics also continues to expand its intellectual property portfolio, which includes more than 270 issued and pending patents in the United States and internationally across wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, longevity and cancer. With the first patients now dosed in the CYWC628 Phase 1/2 study, clinical data expected during the second half of 2026 will become an important test of the company’s fibroblast spheroid technology in diabetic foot ulcers. The combination of clinical development, cGMP manufacturing progress and an expanding regenerative medicine pipeline positions CYWC628 as a key near-term program for FibroBiologics as it evaluates the therapeutic potential of fibroblast-based cell technologies.
Source: FibroBiologics press release
