US-based biotechnology firm RXi Pharmaceuticals has enrolled the first patient in a Phase II trial of its anti-scarring product RXI-109.
In the trial, patients with a long hypertrophic scar in the lower abdominal area will be given RXI-109 or placebo on a blinded basis at the distal ends of their revised scar, leaving a central untreated section of the scar.
According to the company, each patient’s revised scar area will help in comparing the appearance of the revised areas after treatment with RXI-109 or placebo or when left untreated.
RXi Pharmaceuticals president and CEO Geert Cauwenbergh said that the start of the first Phase II clinical study with RXI-109 is an important step in bringing the company’s first self-delivering (sd-rxRNA) RNAi closer to the market.
"Not only can the outcome of this first Phase II study create a novel treatment approach in an area where no FDA approved drugs exist; it should also confirm the clinical relevance of our proprietary sd-rxRNA approach for human diseases in a broader sense, creating numerous business development opportunities that could add substantial value to our company," Cauwenbergh added.
Two additional Phase II trials are scheduled to be initiated in the near future; the first of these will assess the effect of RXI-109 on the recurrence of keloids after keloid revision surgery, while the second will evaluate the effect of the compound on suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.
RXI-109 is designed to reduce the expression of connective tissue growth factor, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin.
According to the company, the first clinical trials of RXI-109 demonstrated excellent safety and tolerability with ascending single or multiple doses.