FibroBiologics (NASDAQ:FBLG) took a decisive step toward clinical-stage operations on Wednesday, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to begin Phase 1/2 trials for its lead psoriasis candidate, CYPS317.
The therapy, an allogeneic fibroblast spheroid-based treatment, is designed for patients with moderate to severe psoriasis.
Unlike traditional biologics that typically target single cytokines, CYPS317 utilizes the immunomodulatory properties of fibroblasts—cells traditionally known for structural support—to reset the inflammatory environment of the skin.
The submission is bolstered by head-to-head preclinical data that captured investor attention.
In animal models, a single dose of CYPS317 not only matched but in several cases exceeded the therapeutic efficacy of multiple doses of anti-IL-23 monoclonal antibodies—the current "gold standard" for psoriasis care.
Perhaps more significantly for patients, the fibroblast treatment demonstrated a marked reduction in disease recurrence, suggesting a more durable response than existing periodic injections.
The Houston-based company, which holds over 270 patents, is betting that its fibroblast platform can overcome the "ceiling" of current biologic efficacy.
While anti-IL-23 drugs like Skyrizi and Tremfya have revolutionized care, many patients eventually experience diminishing returns or relapse.
CYPS317 aims to address this by combining extracellular matrix signaling with broad-spectrum immunomodulation.