Biotechnology company RXi Pharmaceuticals has announced the completion of enrolment in the second Phase I trial of RXI-109, to manage surgical and hypertrophic scars and keloids.
The anti-scarring drug RXI-109, a self-delivering RNAi compound, is designed to reduce the expression of a critical regulator of biological pathways involved in fibrosis CTGF.
The tissue repair process could be prolonged due to elevated levels of CTGF-dependent signalling, resulting in pathological scarring.
RXi Pharmaceuticals president and CEO Dr Geert Cauwenbergh said enrolment for the study was completed within the scheduled time frame.
"The safety profile of RXI-109, continues to be excellent, and the company hopes to extract valuable information from these studies that will contribute to the design of our Phase IIa studies in terms of dose and treatment frequency," Cauwenbergh said.
The double blind multi-dose study will administer three intra-dermal injections for a period of two weeks, with each subject receiving both active and placebo.
Study is designed to evaluate safety and tolerance parameters and systemic exposure to the drug, in addition to measuring mRNA levels of CTGF and several other biomarkers important for wound healing and scarring.
RXI-109 has demonstrated a significant safety and tolerability profile with ascending single doses in the first clinical trial of RXI-109.