RXi Pharmaceuticals, a biotechnology company, has announced the completion of dosing in a Phase I study of RXI-109, the first self-delivering RNAi compound (sd rxRNA) in clinical development.
RXI-109 is being developed to prevent or reduce dermal scarring following surgery or trauma, as well as for the management of hypertrophic scars and keloids.
RXi president and CEO Dr Geert Cauwenbergh said sd rxRNA, as a technology, can be used locally over a range of concentrations in a safe and well-tolerated manner.
"In the past, concerns have been raised over the tolerability of RNAi compounds in clinical trials for systemic organ diseases," Cauwenbergh said.
"These clinical data in skin and dermis confirm our earlier observations in animal studies that RXi's self delivering (sd) technology can be used safely for disease indications where local delivery is appropriate.
"The subjects continue to be followed with photographic documentation of their incision sites for a direct visual comparison, and biopsies of these sites at the time of the scheduled abdominoplasties, will allow direct comparison of RXI-109 versus placebo treated sites on a histological level."
The double-blind dose, escalation study enrolled 15 subjects scheduled to undergo abdominoplasty, and administered single intradermal injections in a dose-dependent manner to five cohorts of three subjects each.
RXI-109 was well tolerated by intradermal injection in the subjects who received an RXI-109 injection in two separate areas on the abdomen, and placebo injections in two other areas of the abdomen.
The company evaluated safety and tolerance data of each cohort before proceeding to the next cohort with a higher dose level.