FibroBiologics, Inc., a clinical-stage biotechnology company focused on fibroblast-based therapeutics, has submitted a Phase 1/2 Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CYPS317, an allogeneic fibroblast spheroid therapy targeting moderate to severe psoriasis.
The IND filing marks a key step in FibroBiologics’ chronic inflammatory disease pipeline, following preclinical studies demonstrating that a single dose of CYPS317 produced therapeutic effects comparable to multiple doses of anti-IL-23 monoclonal antibodies in animal models. Preclinical data also showed significant reductions in disease recurrence, highlighting the therapy’s potential durability and immunomodulatory properties.
The submission includes comprehensive preclinical pharmacology, safety, and manufacturing data, supporting CYPS317’s mechanism of action, durability, and safety profile. The company plans to advance first-in-human clinical trials after FDA review.
Psoriasis affects over eight million adults in the United States and remains a condition with significant unmet medical needs, particularly in achieving durable responses with favorable safety profiles despite the availability of biologic therapies. CYPS317 aims to address these gaps by leveraging fibroblast spheroids to modulate the immune response and restore tissue homeostasis.
FibroBiologics continues to develop additional fibroblast-based therapies for a range of chronic diseases, supported by its platform of engineered organoids and fibroblast spheroids, and a portfolio of more than 270 issued and pending patents.
