FibroBiologics, Inc. (NASDAQ: FBLG) filed a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration to begin clinical trials of its allogeneic fibroblast spheroid therapy CYPS317 for moderate to severe psoriasis. The IND submission includes comprehensive preclinical pharmacology, safety, and manufacturing data that support the therapy’s mechanism of action, durability of effect, and safety profile.
CYPS317 is designed to reduce psoriasis disease severity and relapse. In preclinical studies, a single dose of CYPS317 matched or exceeded the efficacy of multiple doses of anti‑IL‑23 monoclonal antibodies, and it demonstrated a significant reduction in disease recurrence. The data suggest that the therapy could offer durable responses with a potentially favorable safety profile compared with existing biologics.
The filing marks a significant advance in FibroBiologics’ chronic inflammatory disease pipeline. The company aims to obtain IND clearance for all four of its product candidates in 2026, and CYPS317 is the first to move from preclinical validation toward first‑in‑human studies. The psoriasis market serves over eight million adults in the United States, and unmet needs remain despite current biologic options, positioning CYPS317 as a potential new therapeutic avenue.
FibroBiologics’ financial profile reflects a company in early‑stage development. The firm reported an EBITDA of –$17.55 million and a market capitalization of approximately $14.83 million as of December 31 2025. In December, the company completed a $1.7 million direct offering to raise capital, underscoring the need for additional funding to support its clinical and regulatory programs.
Management emphasized the strategic importance of the IND filing. Founder and CEO Pete O’Heeron said, “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.” Chief Scientific Officer Hamid Khoja 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.”
The IND filing is a regulatory milestone that will allow FibroBiologics to begin human testing, potentially opening a new revenue stream for its fibroblast‑based platform and providing a foundation for future product development across multiple chronic disease indications.
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