Track topics on Twitter Track topics that are important to you
RXi Pharmaceuticals’ first clinical candidate is RXI-109, a self-delivering RNAi compound (sd-rxRNA) being developed to reduce dermal scarring following planned surgeries. RXI-109 is designed to reduce the expression of CTGF, a critical regulator of several biological pathways involved in fibrosis, including scar formation in the skin. Development activities in 2011 and early 2012 included the completion of IND-supporting toxicology studies, preparation of the clinical drug supply and the successful filing of an IND. RXI-109 received FDA clearance to enter clinical trials, and a Phase 1 clinical trial was initiated in June 2012. While the primary focus of this first trial in healthy volunteers was the safety and tolerability of RXI-109, there are also several surrogate endpoints evaluated that may provide evidence of clinical efficacy. In June and July of this year we announced that our first clinical trials of RXI‑109 showed excellent safety and tolerability with ascending single or multiple doses.
In early November, we initiated our Phase 2 study with the anti-scarring product RXI-109. In this study (RXI-109-1301), patients with a long hypertrophic scar in the lower abdominal area are eligible to receive scar revision surgery and subsequent treatment with RXI-109 in one of two treatment regimens. Patients will receive RXI-109 or placebo on a blinded basis at the distal ends of their revised scar, leaving a central untreated section of the scar. Each patient’s revised scar area will provide the opportunity to compare the appearance of the revised areas after treatment with RXI-109 or placebo or when left untreated. This design allows for intra-subject comparison of the three revised scar segments, as such increasing the power of the study.
RXI-109 is a lipophilically-enriched RNA-antisense hybrid therapeutic that is designed to reduce connective tissue growth factor (CTGF) expression.