Preclinical Efficacy and Safety Study of a Novel Dermal Fibroblast Modulating Drug, SLI-F06, in Cutaneous Wound...

Scarring results in significant developmental, functional, aesthetic, and psychological challenges. Despite substantial demand from patients and healthcare providers, no drugs or biologics are currently approved specifically for preventing or reducing scarring. Our previous studies indicate that fibromodulin (FMOD) modulates adult dermal fibroblasts to adopt fetal-like characteristics, thereby improving wound appearance, reducing scar size, and enhancing tensile strength in adult skin healing. To address the high costs, variability, and safety concerns of producing FMOD through mammalian cells, a novel, chemically synthesized FMOD-derived peptide, SLI-F06, has been developed. SLI-F06 retains FMOD's essential properties, such as promoting cell migration, increasing tensile strength, and stimulating antifibrotic effects. Comprehensive animal studies using models such as mice, rats, Yorkshire pigs (the standard for normal human wound healing), and red Duroc pigs (closely mimicking human proliferative and hypertrophic scarring) demonstrate significant improvements in scar appearance, tensile strength tests, and histological outcomes with SLI-F06. Additionally, a formulation buffer has been developed to maintain physiological pH and osmolality, ensuring the stability of SLI-F06 for a suitable duration in clinical settings after removal from refrigeration. SLI-F06 exhibits no genotoxicity or local or systemic toxicity in extensive studies required by the United States Food and Drug Administration for Investigational New Drug applications.