Antibacterial drug company Trius Therapeutics Inc. brought in $30 million in its second venture round to advance into Phase II and Phase III studies with lead program, TR-701, an oxazolidinone antibiotic that has indicated promising results from an ongoing Phase I study.
That trial, started in January, is testing TR-701 against New York-based Pfizer Inc.'s Zyvox, the only approved oxazolidinone compound, in 88 subjects with serious Gram-positive bacterial infections, including those caused by Methicillin-resistant Staphylococcus aureus (MRSA) and other drug-resistant strains.
While Trius has not yet disclosed those data, President and CEO Jeff Stein called the results so far "better than expected."
"We initially planned to raise our Series B in the third quarter," he told BioWorld Today. "But based on the positive [Phase I] results, we decided to accelerate development" of TR-701.
Funding from the latest round should get that program all the way into Phase III testing, which the company anticipates starting in about 18 months if all goes as planned, he said.
Trius will be looking at TR-701 in complicated skin and soft-tissue infections as its first indication, likely to be followed later with trials in hospital-acquired pneumonia. That means the San Diego-based firm has been following closely the recent FDA actions in the antibiotic space, with potential competing products, including glycopeptides telavancin (Theravance Inc. and Astellas Pharma US) and dalbavancin, (Pfizer), both getting approvable letters last year, and ceftobiprole, a cephalosporin drug from Basilea Pharmaceutica AG and a unit of Johnson & Johnson, getting its own approvable letter just last week.
Much of the agency's reticence has been attributed to the recent scrutiny over its 2003 approval of Ketek (telithromycin), a ketolide antibiotic from Paris-based Sanofi-Aventis Group that has been tied to possible safety risks and allegations of data manipulation in clinical trials.
Other drugs are pending review, such as Targanta Inc.'s oritavancin, another glycopeptides antibiotic, and Arpida AG's iclaprim, a synthetic diaminopyrimidine, and the industry will have to wait and see whether they will have a cleaner path to market.
Right now, Trius is banking on the compound's promising data so far, and Stein said TR-701 already has shown a number of "compelling" characteristics.
For starters, it's part of the oxazolidinone class and has both intravenous and oral availability, similar to Pfizer's Zyvox, a drug that will "probably sell for a billion this year," Stein said, adding that "one of the reasons sales are so high is that it's the only drug to hit MRSA with both an I.V. and an oral formulation."
And as a second-generation oxazolidinone prodrug, TR-701 offers a few other advantages, such as once-daily dosing, compared to Zyvox's twice-daily regimen, and reduced dosing frequency "results in better compliance," Stein said.
The spread of drug-resistant bacterial infections increases when patients go off their treatment regimens, and that indicates once-daily dosing should slow down drug resistance. On top of that, Stein said, TR-701 also has demonstrated activity against Zyvox-resistant strains of MRSA, and appears to have a "good safety window."
Trius gained worldwide rights, except for South Korea, to TR-701 and other oxazolidinone agents from Dong-A Pharmaceutical Co. Ltd., of Korea, in early 2007, around the same time it closed its $20 million Series A round. (See BioWorld Today, Feb. 28, 2007.)
At this time, the firm of 28 employees plans to advance TR-701 on its own, at least through Phase II, Stein said. "Then we'll evaluate" whether to seek partnering opportunities or continue advancing the compound internally.
Beyond TR-701, Trius has a preclinical pipeline emerging from its structure-based drug discovery platform. The most advanced are a program targeting dihydrofolate reductase and one targeting bacterial DNA gyrase. Funds from the Series B round will be used to move one of those two into the clinic, Stein said.
Investment firm Kleiner, Perkins, Caufield and Byers (KPCB), of Menlo Park, Calif., led Trius' recent financing, with participation from new investor, Tokyo-based FinTech Global Capital, as well as existing investors San Francisco-based Sofinnova Ventures; Needham, Mass.-based Prism VentureWorks; and Versant Ventures and Interwest Partners, both of Menlo Park.
Risa Stack, partner at KPCB, joined Trius' board.
In other financings news:
• Chromos Molecular Systems Inc., of Burnaby, British Columbia, said it entered a secured, convertible debenture agreement to borrow $400,000 to fund expenses associated with the preparation of delinquent continuous disclosure documents and maintaining the integrity of the company's remaining assets. Chromos also entered a convertible promissory note deal to loan $500,000 to Agrisoma Biosciences Inc., which Chromos spun out in 2004. Of that amount, $118,000 was funded in-kind by Chromos by offsetting it against $118,000 of amounts due from Agrisoma for license fees, rent and other services and patent cost recoveries. The remaining $382,000 was funded in cash by Chromos and will be used to fund operations at Agrisoma.