FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis.

This IND filing represents a major advancement for FibroBiologics’ chronic inflammatory disease pipeline and follows a series of positive IND-enabling preclinical results demonstrating the potential of fibroblast spheroids to significantly reduce psoriasis disease severity and relapse in preclinical models. In animal studies, a single dose of CYPS317 matched or exceeded the therapeutic effects of multiple doses of anti-IL-23 monoclonal antibodies and yielded significant reductions in disease recurrence, underscoring both the durability and immunomodulatory capacity of this approach.

FibroBiologics is pursuing a development program for CYPS317 with the goal of advancing first-in-human clinical trials following FDA review of the IND filing. The IND submission includes comprehensive preclinical pharmacology, safety, and manufacturing data supporting the therapeutic’s mechanism of action, durability of effect, and safety profile.

Psoriasis is an autoimmune skin disease that affects over eight million adults in the United States alone and can significantly impair quality of life and productivity. Despite advances in biologic treatments, unmet needs remain, particularly in achieving durable responses with favorable safety profiles.

“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.”

Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, added: “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.”

FibroBiologics continues to develop additional fibroblast-based therapies across a range of chronic disease indications, leveraging its differentiated platform of engineered organoids and native fibroblast spheroids and a broad intellectual property estate.