In this study, subjects received small skin incisions in their abdomen and were treated with 3 intradermal doses of RXI‑109 over a 2-week period. This dose escalating study consisted of 3 cohorts of 3 healthy volunteers each. Subjects received RXI‑109 on one side of the abdomen, and placebo on the other side.
Subjects were monitored for safety and local and systemic side effects over a total study period of 84 days.
Multiple dermal injections were well tolerated at all doses and treatment with RXI‑109 resulted in dose-dependent silencing of CTGF mRNA in the treated areas.
Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals said that, "We are very pleased with the outcome of this second Phase 1 study. These results show that multiple intradermal injections of RXI‑109 are well tolerated with minimal and mild side effects. He added that, "The work done in the last year has confirmed that our proprietary self-delivering RNAi technology (sd-rxRNA) reduces CTGF mRNA in humans in line with its mechanism of action. Indeed, results from this second study demonstrate that mRNA for CTGF in the incisions is reduced in a dose-dependent manner by RXI‑109 as compared to placebo. Our first Phase 1 study had already shown that a single dose of the drug lowered the actual protein content for CTGF also in a dose-dependent manner. With this exciting outcome, we are ready to embark on Phase 2 development in patients with hypertrophic scars and keloids."