Biotechnology company RXi Pharmaceuticals has reported positive data from a second Phase I multi-dose study of an sd-rxRNA compound, RXI 109, which targets connective tissue growth factor (CTGF).
RXI 109 is being developed to treat abnormal dermal scars such as hypertrophic scars and keloids in combination with scar revision surgery.
In the study, subjects were treated with three intradermal doses of RXI 109 over a period of two weeks after receiving small skin incisions in the abdomen.
Comprising three cohorts of three healthy volunteers each, the subjects received RXI 109 on one side of the abdomen, and placebo on the other side in the dose escalating study.
After monitoring the subjects for safety and local and systemic side effects over an 84 day-period, the study noted that multiple intradermal injections of RXI 109 was well tolerated.
The study also concluded that the treatment with RXI 109 resulted in dose-dependent silencing of CTGF mRNA in the treated areas.
RXi Pharmaceuticals president and CEO Dr Geert Cauwenbergh said the results indicate that multiple intradermal injections of RXI 109 are well tolerated with minimal and mild side-effects.
"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," Cauwenbergh said.
"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."
First Phase I study demonstrated the efficacy of a single dose of the drug in lowering the actual protein content for CTGF also in a dose-dependent manner.
The company now plans to begin Phase II development in patients with hypertrophic scars and keloids.