Roughly three months after officially opening its Chinese subsidiary, Sirnaomics is weighing the possibility of conducting its first clinical trial, a phase I study of the ocular disease drug STP-601, in nearby Hong Kong, RNAi News has learned.
Although it had originally expected to conduct the study in China, the company later decided to do so in the US in light of Chinese regulators’ unfamiliarity with RNAi technology and concerns over whether the US Food and Drug Administration would accept the data (see RNAi News, 9/20/2007 and 7/31/2008).
And while a US trial is still an option, the company is now also considering running the study in Hong Kong, a special administrative region under Chinese control that Sirnaomics President and CEO Patrick Lu classified as a sort of regulatory middle ground between the US and China.
Currently, the US Food and Drug Administration will allow a company to perform clinical studies of a drug in Hong Kong once the agency has approved the relevant investigational new drug application, Lu told RNAi News this week. At the same time, Chinese regulators will accept data from trials conducted in Hong Kong.
Sirnaomics does envision a time when it could run trials in China and use the resulting data in FDA regulatory packages, but just when this may happen is uncertain.
Lu said that there is precedent for including Chinese data in a US new drug application, pointing to Bayer’s recently approved cancer drug Nexavar, which was evaluated in a phase III study that included sites in China, Korea, and Taiwan. But whether the FDA will accept data from trials run only in China, however, is not known, he added.
In the end, Lu said Sirnaomics primarily will consider “speed and cost” in deciding whether to conduct a phase I study of STP-601 in the US or Hong Kong. However, the company does not want to unnecessarily rush things since the trial will act as a kind of “pilot study to find out the best way to go ahead with other candidates.
“That’s why we’re carefully evaluating the best scenario for us in the long run,” he said.
As a result of its deliberation, Sirnaomics doesn’t expect to meet its previous goal of beginning the STP-601 trial in the first quarter of this year, Lu said. Still, “we’re doing everything we can to get it started this year,” he added.
Although Sirnaomics has enough funds to begin clinical testing of STP-601 on its own, Lu said, the company remains open to partnership opportunities. Despite its new Asian presence, however, it is unlikely that Sirnaomics will find its first industry collaborator in China.
“We are talking to some people [in Chinese pharmaceutical firms] but … their understanding of RNAi therapeutics is still in a very early stage,” Lu said. “They see what is happening in the US and Europe … [but they] aren’t really sophisticated enough to value an RNAi therapy approach yet.”
While Sirnaomics had previously expected its investigational pandemic influenza drug STP-702 to follow STP-601 in its pipeline, the firm’s wound-healing program has since moved up in the queue.
“We are [now] thinking that that program will be the next one to move forward into clinical studies,” David Evans, Sirnaomics vice president of discovery research, told RNAi News.
The drug, called STP-705, is being developed through a 50/50 partnership with General Research Laboratory and comprises siRNAs against two undisclosed targets delivered in a proprietary nanoparticle formulation.
In animal studies, Sirnaomics has found that treatment with STP-705 promoted scarless wound healing and rapid wound closure, which “could have implications in any surgery-based applications where there is the potential for scarring,” Evan said. Additionally, the drug may prove useful in treating wounds associated with diabetes, burns, and battlefield injuries, he added.
Although GRL and Sirnaomics share rights to STP-705, Lu said that the companies are interested in finding a bigger partner with both clinical and marketing expertise. As with STP-601, however, Sirnaomics does not expect it will need to do so before beginning human trials of the drug.
Last year, Lu had projected that STP-705 could enter phase I testing by the end of this year. This week, however, he said that early 2010 is a more likely timeline.