Date: 2015-10-20
Type of information: Results
phase: 2
Announcement: results
Company: RXi Pharmaceuticals (USA - MA)
Product: RXI-109
Action
mechanism: RNAi. RXI-109 is a self-delivering RNAi (sd-rxRNA®) compound developed to target connective tissue growth factor (CTGF), a key regulator in scar formation. The goal is to block the formation of sub-retinal scarring that is secondary to the neovascular disease of wet AMD in order to preserve vision for a longer period of time.
Disease: hypertrophic scar
Therapeutic area: Dermatological diseases
Country: Honduras, USA
Trial
details: The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic abdominal scar.(NCT02030275)
Latest
news: * On October 15, 2015, RXi Pharmaceuticals, a biotechnology company that owns a broad intellectual property portfolio including a unique self-delivering RNAi platform, announced that results from a blinded panel and an Investigator review show that incision sites treated with RXI-109 after scar revision surgery achieved better scores as compared to control incision sites in the same subjects, three months post scar revision surgery. In the first two arms of this ongoing Phase 2a study, subjects were given six intradermal injections of RXI-109, either at 5 mg/cm or 10 mg/cm, beginning two weeks after scar revision surgery, with the last of the six doses administered three months post revision surgery. Subjects had one portion of the revised scar treated with RXI-109, whereas another part of the scar was revised but left untreated. This 3-month analysis included 16 subjects of which 15 were evaluable and 1 was lost to follow-up. Of those 15 subjects, eight were treated with 5 mg/cm of RXI-109 and seven were treated with 10 mg/cm of RXI-109. All subjects were assessed using four different evaluation methods: - POSAS (Physician and Observer Scar Assessment Scale): A compiled score based on investigator assessments of factors contributing to scar quality. These scores are provided by the investigators for both the treated and the untreated portion of the scar of their individual subjects in person; - VAS (Visual Analogue Scale): A score based on a 10 point scale ranging from "1" (fine line scar) to "10" (worst scar possible) provided by the investigators for their individual subjects; - A blinded assessment of photographs of the revision sites for 15 subjects by Investigators in which the clinicians were asked to indicate for Scars A and B as to which is 'better' or 'not different'; - A separate assessment of photographs of the revision sites for 15 subjects by a blinded panel, separate from the Investigators, in which the panel members were asked to indicate for Scars A and B as to which is 'better' or 'not different' . Overall, the RXI-109 treated revision sites were scored statistically significantly better than the untreated revision sites in all four evaluations. Both dose levels of RXI-109 were equally well tolerated with occasional transient redness and itching occurring in both dose levels. Moreover, the higher dose of 10 mg/cm did not appear to add clinical benefit over the 5 mg/cm dose, leading to the conclusion that the next cohorts in this ongoing RXI-109-1402 study will be treated with the 5 mg/cm dose. These subsequent cohorts will include evaluation of additional treatments through six months to further define the optimum treatment regimen. * On December 17, 2014, RXi Pharmaceuticals announced completion of enrollment in its first Phase 2a study, RXI-109-1301. The preliminary results from the 3-month observations confirmed the 1-month findings that were reported in September of this year. When treatment with RXI-109 was initiated 2-weeks post scar revision surgery, blinded evaluators were able to identify accurately the RXI-109 treated site at the 3-month follow-up more frequently (54%) than when treatment was initiated immediately post scar revision surgery (24%) (p< 0.0001 Fisher exact 2-tailed). These data provide guidance that dosing with RXI-109 during the proliferation phase provides a better outcome than dosing during the acute inflammatory phase of the wound healing process. The results support the Company's decision, for the ongoing Phase 2a studies, to start treatment 2-weeks post scar revision surgery (at the end of the acute inflammation phase), and explore extension of the treatment during the weeks of the proliferation phase (the period in the wound healing process during which hypertrophic scars can develop). Based on these observations, the treatment regimens for the ongoing studies for revised keloids and scars, RXI-109-1401 and 1402 respectively, will be altered to optimize the timing and duration of dosing for RXI-109 in these indications. * On October 7, 2014, RXi Pharmaceuticals announced that a review of the first two enrolled patients' clinical photographs in the first Phase 2a clinical trial (RXI-109-1301), indicate that treatment with the Company's lead clinical candidate, RXI-109, may be effective in suppressing recurrence of hypertrophic scars at the 3-month time point. Patients will continue to be monitored through 9 months to evaluate if this outcome persists over time. On September 10th of this year, the Company announced that based on early 1-month observations, the dosing regimen in these trials can be fine-tuned, allowing the Company to more rapidly move forward with treatment optimization for the prevention of scarring after surgery. Today's presentation will provide 3-month photographs from the first two patients enrolled in study RXI-109-1301 that indicate treatment with RXI-109 shows a clinical benefit. The safety information in this ongoing study to date, continues to confirm that RXI-109 is well tolerated with no overt systemic side effects. Local effects are mild and similar to those seen in the Company's prior Phase 1 clinical trials (erythema, occasional, transient burning or stinging sensation). Complete 3-month results from this trial are expected to be available in Q1 2015. * On November 13, 2013, RXi Pharmaceuticals announced that the first patient has been enrolled in a 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 Pharmaceticals has indicated that two additional Phase 2 studies will be initiated in the near future. The first of these will evaluate the effect of RXI-109 on the recurrence of keloids after keloid revision surgery. The second study will evaluate the effect of RXI-109 on suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.
