Industry News

Phase 1 study of hypertrophic scar, keloid treatment called positive

RXi Pharmaceuticals recently announced positive phase 1 study results regarding its RXI-109 for treatment of abnormal dermal scars, including hypertrophic scars and keloids in conjunction with scar revision surgery.

In a second phase 1 study, researchers evaluated nine healthy patients who received three intradermal doses of RXI-109 — a self-delivering ribonucleic acid interference compound (sd-rxRNA) targeting connective tissue growth factor (CTGF) to reduce dermal scarring — in their abdomen during a 2-week period, according to a press release. Three cohorts of three patients each received RXI-109 on one side of the abdomen and placebo on the other. Safety and side effects were monitored during the 84-day study.

The multiple injections were well tolerated at all doses, according to the release.

“Treatment with RXI-109 resulted in dose-dependent silencing of CTGF messenger RNA [mRNA] in the treated areas,” according to the release.

“We are very pleased with the outcome of this second phase 1 study,” Geert Cauwenbergh, PhD, president and CEO of RXi Pharmaceuticals, said in the release. “The work done in the last year has confirmed that our proprietary self-delivering RNA interference technology reduces CTGF mRNA in humans in line with its mechanism of action. Results … 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. We are ready to embark on phase 2 development in patients with hypertrophic scars and keloids.”

RXi Pharmaceuticals recently announced positive phase 1 study results regarding its RXI-109 for treatment of abnormal dermal scars, including hypertrophic scars and keloids in conjunction with scar revision surgery.

In a second phase 1 study, researchers evaluated nine healthy patients who received three intradermal doses of RXI-109 — a self-delivering ribonucleic acid interference compound (sd-rxRNA) targeting connective tissue growth factor (CTGF) to reduce dermal scarring — in their abdomen during a 2-week period, according to a press release. Three cohorts of three patients each received RXI-109 on one side of the abdomen and placebo on the other. Safety and side effects were monitored during the 84-day study.

The multiple injections were well tolerated at all doses, according to the release.

“Treatment with RXI-109 resulted in dose-dependent silencing of CTGF messenger RNA [mRNA] in the treated areas,” according to the release.

“We are very pleased with the outcome of this second phase 1 study,” Geert Cauwenbergh, PhD, president and CEO of RXi Pharmaceuticals, said in the release. “The work done in the last year has confirmed that our proprietary self-delivering RNA interference technology reduces CTGF mRNA in humans in line with its mechanism of action. Results … 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. We are ready to embark on phase 2 development in patients with hypertrophic scars and keloids.”