FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending focused on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced a strategic expansion of its fibroblast-based platform to target Hantavirus. Building on existing preclinical work in treating acute respiratory distress syndrome (ARDS), the major cause of lethality in COVID-19 patients, FibroBiologics is expanding its therapeutic platform to encompass Hantavirus pulmonary syndrome (HPS), which causes similar terminal lung damage and inflammatory cascade as severe COVID-related ARDS.

HPS is a rare but severe respiratory illness generally transmitted through contact with infected rodents. The disease progresses rapidly, causing severe pulmonary edema and multi-organ failure, with mortality rates exceeding 35-40%, even in clinical settings. Currently, there are no approved antiviral therapies or disease-modifying treatments for HPS, leaving patients dependent on supportive care. The pathophysiology of HPS involves uncontrolled inflammatory responses, endothelial barrier dysfunction, and progressive pulmonary fibrosis, mechanisms that FibroBiologics' fibroblast platform is specifically designed to modulate. Patients surviving acute HPS frequently develop chronic complications including pulmonary fibrosis, reduced lung capacity, and long-term respiratory impairment.

Preclinical studies in ARDS models have demonstrated that fibroblasts can reduce excessive inflammatory signaling, restore endothelial barrier integrity, and promote tissue repair, precisely the pathogenic processes that characterize severe Hantavirus disease. The terminal lung damage observed in critical HPS cases mirrors the acute respiratory failure seen in ARDS, making FibroBiologics' fibroblast platform uniquely positioned to address this unmet need. The company believes its therapeutic approach, which leverages the immunomodulatory and regenerative properties of fibroblasts, can counteract the hyperinflammatory state and tissue destruction inherent to HPS.

FibroBiologics is now evaluating its fibroblast platform in Hantavirus disease models, with particular emphasis on inflammatory cytokine modulation and endothelial permeability reduction. The company plans to initiate exploratory discussions with regulatory authorities to establish a development pathway toward clinical evaluation in HPS patients.

Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics said, "HPS represents one of the most severe and under-addressed viral respiratory threats facing global health today. We believe our fibroblast platform has the ability to control cytokine storms and restore lung architecture in ARDS patients. The disease mechanisms in HPS are strikingly similar to those in ARDS, and we believe fibroblast-based therapeutics could offer genuine hope where currently there is none. We are advancing the development of a fibroblast treatment for HPS, recognizing that every advancement in our understanding of fibroblast immunomodulation and regenerative capacity brings us closer to therapies that could change outcomes for patients worldwide.”