FibroBiologics has announced positive IND-enabling preclinical results demonstrating the therapeutic potential of human dermal fibroblast (HDF) spheroids for treating chronic-relapse psoriasis. The Houston-based clinical-stage biotechnology company reported that a single administration of HDF spheroids matched the efficacy of multiple doses of an anti-IL-23 monoclonal antibody in acute psoriasis models.
Single-Dose Efficacy Matches Standard Treatment
The breakthrough findings show that HDF spheroids delivered comparable therapeutic outcomes to established anti-IL-23 monoclonal antibody treatments, but with a single administration versus multiple doses. "In an acute psoriasis model, a single administration of HDF spheroids matched the efficacy of multiple doses of an anti-IL-23 monoclonal antibody," said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics.
More significantly, the same single treatment demonstrated substantial benefits in chronic-relapse models. "Now, in a chronic-relapse model, that same single treatment has been shown to significantly reduce disease recurrence," Khoja added.
Addressing Significant Unmet Medical Need
Psoriasis represents a substantial healthcare burden, affecting over eight million adults in the United States. The autoimmune condition frequently progresses to psoriatic arthritis, significantly impacting patients' quality of life. FibroBiologics is positioning its fibroblast-based approach as a potential paradigm shift from incremental improvements to durable, scalable therapeutic solutions.
"Chronic inflammatory diseases represent a massive, underserved market, and the ability to address them at scale is a generational opportunity," said Pete O'Heeron, Founder and Chief Executive Officer at FibroBiologics.
Expanding Research Program
The company is advancing its research program through multiple complementary approaches. Current efforts include exploring repeated dosing regimens, conducting systemic and local cytokine profiling, and performing histopathological assessments of skin lesions. These studies are designed to deepen mechanistic understanding and strengthen the foundation for clinical advancement.
FibroBiologics is now evaluating whether a single HDF spheroid treatment can deliver long-term protection against psoriasis relapse, which would represent a fundamental change in treating chronic inflammatory diseases.
Clinical Development Strategy
The positive IND-enabling results mark a pivotal milestone in FibroBiologics' development strategy. "These IND-enabling results are a pivotal milestone on our path to building a category-defining company in regenerative medicine," O'Heeron stated. The company emphasizes its focus on durability, safety, and reproducibility as key factors for achieving scalability and market leadership.
FibroBiologics holds over 270 US and international patents issued and pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. The company's fibroblast-based platform represents what it describes as the next generation of medical advancement in cell therapy and tissue regeneration.
