RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that its second Phase 1 study with their anti-scarring drug, RXI-109, for the management of surgical and hypertrophic scars and keloids, has been fully enrolled. This multi-dose study administers 3 intra-dermal injections over a two week period, in a dose ascending manner, with each subject receiving both active and placebo on a double blind basis. This second study not only evaluates safety/tolerance parameters and systemic exposure to the drug but also measures mRNA levels of CTGF and various other biomarkers considered relevant for wound healing and scarring.
“The completion of enrollment for this study has happened well within the projected time frame,” said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, “The safety profile of RXI-109, continues to be excellent, and the Company hopes to extract valuable information from these studies that will contribute to the design of our Phases 2a studies in terms of dose and treatment frequency.”
Skin scarring after surgery, trauma, or burns can cause debilitating aesthetic, functional and psychological effects. There are no FDA-approved therapeutics for treatment of post-operative scars. RXI-109 has been shown in preclinical models to reduce CTGF, a growth factor essential in the wound healing cascade. Elevated levels of CTGF-dependent signaling can prolong the tissue repair process and lead to pathological scarring.
RXi Pharmaceuticals’ first clinical program involves RXI-109, a self-delivering RNAi compound (sd-rxRNA®) developed for the reduction of dermal scarring. RXI-109 is designed to reduce the expression of CTGF, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trial of RXI-109 has shown excellent safety and tolerability with ascending single doses. This second trial uses multiple doses and evaluates safety and side effects of these doses, while also exploring possible effects of RXI-109 on the healing process.