RXi Pharmaceuticals announced the completion of enrollment in its phase 1/2 study RXI-109-1501. This multicenter, multidose, dose escalation trial is being conducted in patients with advanced neovascular or wet age-related macular degeneration (AMD) where retinal scarring can result in continued vision loss. RXI-109 is a self-delivering RNAi (sd-rxRNA) compound developed to target connective tissue growth factor (CTGF), a key regulator of scar formation.
"We are very pleased with the progress of this clinical trial and happy to report that RXI-109 has been well tolerated with no drug related issues occurring to date," Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals, said in a company news release. "The completion of enrollment is an important study milestone as this means that we are likely to finish patient follow-up before year end, as planned and previously communicated."
The primary endpoint for RXI-109-1501 is to evaluate the safety and tolerability of RXI-109, but in the study other endpoints are included to assess RXI-109's potential for clinical activity using numerous assessments to monitor ocular health and visual acuity. In this phase 1/2 study, each subject receives a total of four doses of RXI-109 at 1 month intervals. RXI-109 is administered by intravitreal injection in one eye only. The dosing period (3 months) is followed by a 4 month observation period. Several dose levels are 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.