FibroBiologics Completes Manufacturing of Diabetic Foot Ulcer Drug

The CYWC628 fibroblast-based therapy will enter first-in-human clinical trials in 2026.

Mar. 31, 2026 at 9:53pm

FibroBiologics, a clinical-stage biotechnology company, announced the successful completion of manufacturing the first batch of its proprietary CYWC628 drug product that will support upcoming first-in-human clinical trials for the treatment of diabetic foot ulcers. The drug product was manufactured in accordance with FDA Good Manufacturing Practices.

Why it matters

Diabetic foot ulcers are a serious condition that affects millions of patients worldwide and currently lacks effective long-term treatment solutions. The successful manufacturing of CYWC628, the first fibroblast-based spheroid therapeutic candidate, represents a significant milestone in FibroBiologics' efforts to develop new treatments for chronic diseases using fibroblast cells and materials.

The details

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. FibroBiologics' Founder and CEO, Pete O'Heeron, stated that 'CYWC628 is not only the first fibroblast-based spheroid therapeutic candidate, its manufacture also represents the first large-scale CGMP manufacturing of a spheroid product for therapeutic use.' These achievements by the company's scientific team will allow them to move forward with a planned Phase 1/2 clinical trial utilizing CYWC628 in DFU patients in the first half of 2026.

  • FibroBiologics announced the successful completion of manufacturing the first batch of CYWC628 drug product on March 31, 2026.
  • The company plans to initiate a Phase 1/2 clinical trial utilizing CYWC628 in diabetic foot ulcer patients in the first half of 2026.

The players

FibroBiologics, Inc.

A clinical-stage biotechnology company with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials.

Pete O'Heeron

Founder and Chief Executive Officer of FibroBiologics.

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What they’re saying

“CYWC628 is not only the first fibroblast-based spheroid therapeutic candidate, its manufacture also represents the first large-scale CGMP manufacturing of a spheroid product for therapeutic use.”

— Pete O'Heeron, Founder & Chief Executive Officer of FibroBiologics

What’s next

FibroBiologics plans to initiate a Phase 1/2 clinical trial utilizing CYWC628 in diabetic foot ulcer patients in the first half of 2026.

The takeaway

The successful manufacturing of FibroBiologics' CYWC628 drug product, the first fibroblast-based spheroid therapeutic candidate, represents a significant milestone in the company's efforts to develop new treatments for chronic diseases using innovative cell-based therapies.