FibroBiologics files IND application to initiate clinical trials of CYPS317

FibroBiologics (FBLG) announced the filing of a Phase 1/2 Investigational New Drug application with the U.S. Food and Drug Administration 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 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.