RXi Pharmaceuticals announced positive results with its lead clinical compound RXI-109 in a Phase 2 clinical trial. RXI-109-1402 is an open-label, multi-center, prospective, within-subject controlled study evaluating the effectiveness and safety of RXI-109 on the outcome of scar revision surgery for hypertrophic scars in healthy adults. The primary effectiveness objective was met as shown by a statistically significant improved visual appearance of revised scars after scar revision surgery and treatment with RXI-109 versus control, as assessed by the investigator. The full study results show that the product was safe and well tolerated for all dosage groups. Exploratory endpoint analysis furthermore shows that the cosmetic outcomes of RXI-109 treated scars were highly preferred over the untreated revised scars, by both investigators and patients.
"Today, scarring represents a high unmet medical need and based on our results; I believe that RXI-109 offers a clinically meaningful benefit for the treatment and prevention of hypertrophic scars following scar revision surgery,” Joseph P. Hunstad, MD, FACSA, member of the Board of Directors for the American Society for Aesthetic Plastic Surgery and a Principal Investigator for the company's Dermatology Clinical Program with RXI-109 said. “I look forward to providing further guidance in the development of this exciting new treatment option."
Using the Investigator Scar Assessment Scale, which enables a structured clinical evaluation of scar quality, the difference between RXI-109 treated scars and untreated (control) scars, was statistically significant at all follow-up time points, for one of the treatment arms. The improvement over untreated scars was a mean 6.88 point change at 3 months (p=0.028), a mean 8.00 point change (p=0.013) at 6 months and a mean 7.53 point change (p=0.013) at 9 months post revision surgery. The Investigator Scar Assessment Scale is a validated scoring tool which accounts for several parameters including surface area, pliability, relief, thickness, pigmentation and vascularity.
Using a qualitative measure of overall scar appearance (visual-analog-scale), the difference noted by the Investigator was also statistically significant for all follow-up time points, for the same treatment arm. The improvement over untreated scars was a mean 1.58 point change at 3 months (p=0.012), a mean 1.89 point change (p=0.004) at 6 months and a mean 1.55 point change (p=0.017) at 9 months post revision surgery.
As an exploratory endpoint, patient reported outcome for scar ranking was evaluated. Patients were asked to answer which scar segment (A or B) looks 'better' or if they thought they were 'not different'. For the treatment arm mentioned above, 88% of the patients and 86% of the investigators preferred the RXI-109 treated scar.
Approximately 42 million surgeries occur in the United States alone each year. The American Society of Plastic Surgeons state that more than 170,000 patients receive scar revision therapy annually.