RXi Pharmaceuticals this week announced the pharmacokinetic results of a single dose phase I trial of its intradermal anti-scarring drug RXI-109.
The drug employs RXi's so-called self-delivering RNAi technology to inhibit connective tissue growth factor, a protein linked to wound healing and other fibrotic processes. In September, the company announced that it had completed enrollment in a phase I dose-escalation trial of the agent in 15 healthy volunteers who were scheduled to undergo abdominoplasty (GSN 9/27/2012).
According to RXi, the patients were divided into five cohorts and received single intradermal injections of RXI-109 in a dose-escalating manner, and blood was drawn at various time points to evaluate the distribution of the drug beyond the injected tissue into the systemic circulation.
The company noted that the maximum dose administered to the patients was on average only 0.3 mg/kg at the highest dose, more than 30 times lower than doses tested both intradermally and intravenously in non-human primates. “The calculated relative systemic exposure in the 15 volunteers was between 1 and 7 percent, which is very similar to the systemic exposure in primates,” it added.
As previously disclosed, the drug was well tolerated in all patients.
“These data confirm our first clinical observations, that subjects had no significant side effects or complaints after intradermal injection with RXI-109,” RXi President and CEO Geert Cauwenbergh said in a statement. “Considering the absence of toxicity in our primate toxicology studies at much higher doses, given both intradermally and intravenously, and considering the very similar low degree of systemic exposure we have found in our volunteers, we are confident in moving forward into a multiple dose phase I study in the very near future.”
Also this week, RXi released its financial results for the third quarter, posting a higher net loss on a dividend paid to preferred shareholders.
For the three-month period ended Sept. 30, RXi's net loss was $2.9 million, or $0.02 a share, versus $2 million, or $0.05 a share, in the same period a year earlier. Driving the loss increase was a non-cash dividend of $1.3 million.
Revenues in the quarter were $100,000, compared with zero revenues last year, and reflect the completion of work covered by government grants.
General and administrative costs in the quarter fell to $500,000 from $1 million, while research and development spending rose to $1.2 million from $1.1 million as RXi began phase I testing of its anti-scarring drug RXI-109.
At the end of the quarter, RXi had cash and cash equivalents of roughly $6.3 million.