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RXi Begins Phase II Trial of Anti-scarring Drug, Posts Q3 Results


This article has been updated to include details about RXi's third quarter financial results.

RXi Pharmaceuticals this week announced that it has begun dosing patients in a phase II trial of its investigational anti-scarring drug RXI-109.

Separately, the company announced its financial results for the third quarter, reporting a higher net loss on increased expenses.

RXI-109 comprises siRNAs designed to inhibit connective tissue growth factor, or CTGF, a protein linked to wound healing and other fibrotic processes. It employs the company's proprietary self-delivering technology, which enables cellular uptake without the need for a delivery vehicle.

The phase II trial is enrolling patients with a long hypertrophic scar in the lower abdominal area who are eligible for scar revision surgery. They will receive RXi-109 and placebo on either end of their revised scar, with the center portion being untreated.

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, the company said.

RXi expects to initiate two additional phase II trials, one evaluating the drug on the recurrence of keloids after keloid revision surgery, and the other testing RXI-109's ability to suppress the recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.

Earlier this year, RXi released data from a phase I trial showing that the drug was safe and well tolerated (GSN 7/18/2013).

For the three-month period ended Sept. 30, RXi's net loss rose to $2.1 million from $1.6 million.

Driving the higher loss was an increase in general and administrative expenses to $900,000 from $500,000 on increased headcount, as well as greater board and legal fees associated with the company's recent reverse stock split.

Revenues in the period were essentially flat at $100,000, as were research and development costs, which held at $1.2 million.

At the end of the quarter, RXi had cash, cash equivalents, and short-term investments totaling $15.8 million.