Biotech company FibroBiologics has taken a major step towards human testing of a new psoriasis treatment.
The company has filled a Phase 1/2 Investigational New Drug (IND) application with the US Food and Drug Administration for CYPS317, an experimental allogeneic fibroblast spheroid-based therapy aimed at moderate to severe disease.
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline. CYPS317 is designed to harness fibroblast-derived materials to modulate immune responses and reduce disease severity.
The IND submission follows a series of positive preclinical studies showing that CYPS317 significantly reduced psoriasis severity and relapse in animal models. In those studies, a single dose of the therapy matched or outperformed multiple doses of anti-IL-23 monoclonal antibodies—currently a standard biologic approach—while also delivering durable reductions in disease recurrence.
According to the company, the IND includes extensive preclinical pharmacology, safety, and manufacturing data supporting the therapy’s proposed mechanism of action, durability, and safety profile. FibroBiologics plans to advance CYPS317 into first-in-human clinical trials pending FDA clearance.
Psoriasis affects more than eight million adults in the United States and can severely impact quality of life and productivity. While biologic therapies have improved disease management, many patients still struggle to achieve long-lasting control without safety or tolerability concerns.
“Filing this IND application with the FDA marks a pivotal transition from preclinical research to clinical development for CYPS317 and advances our goal of achieving IND clearance for all four of our product candidates in 2026,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics.
“Psoriasis affects millions of patients who continue to face challenges with existing therapies. We believe allogeneic fibroblast spheroid-based therapeutics have the potential not only to improve disease outcomes, but also to redefine how chronic inflammatory disorders are treated. This filing underscores our commitment to innovation, clinical rigor, and delivering real impact for patients and clinicians.”
Chief Scientific Officer Hamid Khoja, said the therapy’s strength lies in its broad biological activity.
“Our preclinical data suggest that CYPS317 harnesses unique, multi-faceted biological activity, combining extracellular matrix signaling with localized and systemic immunomodulation, which may help restore normal tissue homeostasis in chronic inflammatory conditions such as psoriasis. We are excited to work closely with the FDA as we progress this promising program toward clinical evaluation.”
