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RXi Pharmaceuticals Announces Completion of Enrollment of Phase 1/2 Clinical Trial with RXI-109 for Retinal Scarring
BY PR Newswire
— 7:05 AM ET 06/21/2017

MARLBOROUGH, Mass., June 21, 2017 /PRNewswire/ -- RXi Pharmaceuticals Corporation (RXII) , a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, announced today the completion of enrollment in its Phase 1/2 study RXI-109-1501. This multi-center, multi-dose, 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.

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"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," said Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals. He continued, "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 one month intervals. RXI-109 is administered by intravitreal injection in one eye only. The dosing period (3 months) is followed by a four 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.