RXi Pharmaceuticals this week announced that it has completed patient dosing in a phase I trial of its first clinical candidate, the RNAi-based dermal scarring drug RXI-109.
The drug uses the company's so-called self-delivering RNAi technology to inhibit connective tissue growth factor, a protein linked to wound healing and other fibrotic processes.
In the dose-escalation study, 15 abdominoplasty patients received intradermal injection of RXI-109 in two separate areas on the abdomen and placebo injections on two other areas.
“Data on safety and tolerance were collected and evaluated for each cohort before moving to the next cohort with a higher dose level,” the company said.
RXI-109 was well tolerated, RXi added, and no serious local or systemic side effects were observed in the subjects at any of the doses administered. “Local erythema around the injection site was somewhat more pronounced in the cohort that received the highest dose, but these instances of redness disappeared usually within 72 hours after the injection, and did not give rise to significant subjective complaints from the study subjects.”
RXi said that patients continue to be followed with photographic documentation of their incision sites, and biopsies of these sites at the time of the surgeries will allow direct histological comparison of RXI-109 versus placebo-treated sites.
Data from the trial are expected in the coming months, the company said.