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Moving Fast, Trius Therapeutics Assesses Capital Needs for Late-Stage Clinical Trials

Xconomy San Diego — 

When Luke checked in at Trius Therapeutics almost six months ago, he reported that the San Diego life sciences startup was on a roll, but not quite ready to talk about results of its early stage clinical trials. These days, CEO Jeff Stein says Trius is assessing how best to move ahead in its development of a new anti-bacterial drug, based on results that he characterized as very encouraging.

In developing the drug known generically as torezolid, Stein told me Trius hopes to crack a market for treating MRSA and other drug-resistant infections that is now dominated by Pfizer’s linezolid (Zyvox). He described linezolid, which was approved by the FDA in 2000, as a “blockbuster drug” that generates over $1 billion a year. Linezolid is the only approved compound in the oxazolidinone class of drugs, Stein says, “so for years, just about every anti-infective company has been interested in getting a follow-up drug to Zyvox.”

Trius quickly completed its early stage trials last year, and in January enrolled 180 patients with nasty skin infections in a mid-stage clinical trial. It’s intended to examine the safety and efficacy of torezolid administered orally at three dosage strengths once daily over a five-to-seven day course of treatment.

Trius says more than 90 percent of the germs infecting patients in the trial were Staph infections, and 70 percent of the Staph infections were the “superbugs” known as MRSA, for Methicillin-Resistant Staphylococcus aureus. Trius intends to provide more detailed results of its trial in two or three months, but Stein told me, “Overall, we had about a 96 percent cure rate from our Phase 2 clinical trial.”

In order to go to Phase 3 trials, Stein says, “We’ll either have to do another round of fundraising or bring on a strategic partner.” He says he wants to begin those trials by early next year.

The company has advanced rapidly over the past two years, which Stein says is a testament to the company’s success recruiting key scientists and other personnel. Yet key scientists agreed to join Trius in 2007 chiefly on the strength of its initial $20 million round of venture funding, which was led by San Francisco-based Sofinnova Ventures, where Stein was a partner. The Series A round was joined by InterWest Partners of Menlo Park, CA, Versant Ventures of San Francisco, and Prism VentureWorks of Westwood, MA.

Stein says after he joined the company in mid-2005 as board chairman (later becoming CEO), Trius spent the next 18 months evaluating different anti-bacterial compounds. He found the molecule he was looking for at South Korea’s Dong-A Pharmaceuticals.

“The attractive thing for me was that it was in this Zyvox class of compounds,” Stein says. But the Trius drug candidate appears more promising because it appears to be more potent than linezolid, which means it can be prescribed at lower doses, and because it is more soluble and so can be administered intravenously and orally.

Trius returned to its venture investors in March 2008 to raise an additional $30 million, in a round led by Silicon Valley’s Kleiner Perkins Caufield & Byers. The company also received a $28 million biodefense contract from the National Institutes of Health to develop novel antibiotics against a number of potential bioterrorism infectious agents. Trius is awaiting word on another $68 million in pending defense contracts from the Defense Threat Reduction Agency and the Biomedical Advanced Research and Development Authority, a part of the Department of Health and Human Services.

Stein says the company now has about 35 employees, but Trius could be expanding rapidly over the next year if everything happens according to plan.

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