Date: 2015-11-05
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
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 of scar formation in the skin and known to be involved in retinal scarring as well. This compound silences connective tissue growth factor (CTGF), which plays a key role in tissue regeneration and repair and is initially being developed to reduce or inhibit scar formation in the skin and in the eye.
Disease: prevention of the progression of retinal scarring in patients with advanced neovascular age-related macular degeneration
Therapeutic area: Ophtalmological diseases
Country: USA
Trial
details: RXI-109-1501 is a multi-center, multi-dose, dose escalation trial conducted in subjects with advanced neovascular or 'wet' age-related macular degeneration. In this Phase 1/2 trial, each subject will receive a total of four doses of RXI-109 at one month intervals. RXI-109 will be administered by intravitreal injection in one eye only. The dosing period (3 months) will be followed by a four month observation period. The safety and tolerability of RXI-109, as well as the potential for clinical activity, will be evaluated over the course of the study using numerous assessments to monitor ocular health and visual acuity. Several dose levels will be evaluated in a small number of subjects in this first trial in order to establish safety information and to help determine the dosing regimen for continued study. (NCT02599064)
Latest
news: * On November 5, 2015, RXi Pharmaceuticals announced the initiation of a Phase 1/2 clinical trial in ophthalmology. The clinical study RXI-109-1501 will evaluate the safety and clinical activity of RXI-109 to prevent the progression of retinal scarring. Wet AMD is currently treated with anti-VEGF therapies to block vascular endothelial growth factor (VEGF) from causing blood vessel leakiness and the consequential damage to the retina. However, as the disease progresses, many advanced patients also experience retinal scarring which leads to further vision loss. RXI-109 silences connective tissue growth factor (CTGF), which plays a key role in tissue regeneration and repair. The goal is to reduce or inhibit scar formation that is secondary to advanced wet AMD and in doing so, preserve vision for a longer period time. * On August 31, 2015, RXi Pharmaceuticals announced that the 30-day review period following the filing of the Company's Investigational New Drug (IND) for ocular indications with the FDA has passed and the IND is now active. Preparations are ongoing for the initiation of this Phase 1/2 trial in ophthalmology to evaluate the safety and clinical activity of RXI-109 to prevent the progression of the scarring component of retinal diseases. The process to obtain approval from the Investigational Review Board (IRB) is underway. If the current plan is acceptable to the IRB, a multi-dose, dose-escalating trial will initiate early in the fourth quarter of this year. This Phase 1/2 study will be the Company's first clinical trial with RXI-109 in ophthalmology. RXI-109-1501 will focus on patients with advanced age-related macular degeneration or advanced wet AMD. Currently, there are three ongoing Phase 2a trials evaluating the effect of RXI-109 on scar formation in the skin after surgical revision of hypertrophic scars or keloids. Approximately 100 subjects have been treated with RXI-109 by intradermal injection in all trials to date. RXI-109 has proven to be safe and well tolerated in that target population. The Company expects to provide further updates on its Dermatology and Ophthalmology clinical programs in the coming months.
