RXI Pharma (RXII) Announces Completion of 30-Day RXI-109 IND Review

August 31, 2015 7:03 AM EDT
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RXI Pharma (NASDAQ: RXII) announced that the 30-day review period following the filing of the Company's Investigational New Drug (IND) for ocular indications with the U.S. Food and Drug Administration (FDA) has passed and the IND is now active.

As outlined in the Company's Second Quarter Earnings Call on August 12, 2015, preparations are ongoing for the initiation of a 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. 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.

"As mentioned during our earnings call a few weeks ago, we are pleased to be moving forward one of our seven key initiatives for shareholder value creation," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "Progressing the clinical program for RXI-109 in ophthalmology is a major step in our approach to demonstrate the value of our self-delivering RNAi technology to alleviate diseases in patients who today have little hope for improvements in their advanced disease states. Overall, we are pleased to be advancing RXI-109 for both Dermatology and Ophthalmology, and look forward to initiating additional targeted programs using our self-delivering RNAi platform in these two therapeutic areas."

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.



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