RXi begins study enrollment for hypertrophic scar treatment

RXi Pharmaceuticals has begun enrolling patients with hypertrophic scars for a phase 2 study of its anti-scarring product.

RXI-109 is a self-delivering RNA interference (RNAi) compound (sd-rxRNA) developed for dermal scarring reduction, according to a press release. Patients with long hypertrophic scars in the lower abdominal area will be eligible for study participation to receive scar revision surgery and subsequent treatment with RXI-109 in one of two treatment regimens. RXI-109 or placebo will be used to treat the distal ends of the revised scar in a blinded basis, leaving the central area untreated. The release said this will allow comparison in appearance of the revised area after treatment or left untreated.

In preclinical models, RXI-109 has reduced CTGF, “a growth factor essential in the wound healing cascade.” Prolonged tissue repair process can result from elevated levels of CTGF-dependent signaling and can lead to pathological scarring.

Safety and tolerability in the first trials of RXI-109 were considered excellent, according to the release.

“The start of the first phase 2 clinical study with RXI-109 is a very important step in bringing our first self-delivering RNAi closer to market,” Geert Cauwenbergh, ScD, president and chief executive officer of RXi Pharmaceuticals, said in the release. “Not only can the outcome of this first phase 2 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.”

RXi Pharmaceuticals also disclosed two additional phase 2 studies are planned for the near future. One will evaluate RXI-109 treatment on the recurrence of keloids after keloid revision surgery. The second will study RXI-109’s effect on suppressing hypertrophic scar recurrence after bilateral scar revision surgery in the breast region.