San Diego-based Trius Therapeutics saw what it wanted from a clinical trial of its new antibiotic against deadly MRSA infections, and now it’s gearing up this summer to take its game to a higher level.
Trius reported earlier this week some impressive results from a trial of 188 patients with complicated skin infections who took low, medium, or high doses of its drug, torezolid (TR-701). The treatment caused 98 percent of patients on the lowest dose to be clinically cured, with no side effects serious enough to make patients drop out of the study. While this is medically intriguing, and enough for Trius to pick the right dose, it’s not enough proof for FDA approval. So I followed up with Trius CEO Jeff Stein to find out what’s coming next.
Before getting too far into that, it’s worth a reminder of what Trius is trying to accomplish. The company’s experimental antibiotic is from the same class of treatment as Pfizer’s linezolid (Zyvox). The Pfizer drug generated $1.12 billion in sales last year, so a lot of people think it’s a worthwhile advance in the fight against dangerous infections, like MRSA bacterium that people tend to pick up in hospitals. Trius hopes to offer a better alternative—a pill that can be taken at a lower dose, over a shorter period of time, and be given once a day instead of twice. That’s important, because greater convenience means patients are more likely to follow doctors’ orders—taking an antibiotic as prescribed is critical to wiping out the bug, and reducing the chances of drug resistance.
The full clinical trial results are expected to be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in September, but Stein said there’s nothing in the data that’s disappointing. The Trius group, with about 35 employees, is working on a pivotal clinical trial strategy that will enroll about 1,200 patients in a pair of studies required by the FDA. They are also putting some resources into an intravenous formulation of the drug. And they’re talking with potential partners with the money and manpower to take this drug the rest of the way.
“I’m not aware of results from other companies with an oral drug that’s this effective, in a once-daily pill given over a short course of treatment,” Stein says. “That’s our difference.”
The first big trial—still in a draft form—sounds like it ought to generate the kind of unequivocal answer that the FDA and doctors want to see about a new drug. It will randomly assign patients to get either the low dose of the Trius drug, 200 milligrams, once a day for seven days, or a 600 milligram dose of the Pfizer drug twice a day for 10 days, the FDA approved dosage, Stein says.
A second trial is expected to be structured so that patients start on an intravenous form of the Trius drug, and then switch over to an oral pill. That’s an important protocol, Stein says. Some patients in the hospital need an intravenous form because they are already on an IV in the hospital for some other reason, or they have difficulty swallowing, yet insurers want to see patients switched to a lower-cost treatment alternative quickly, Stein says.
Since cash is an issue for every biotech company still in the product development phase, I asked Stein how his balance sheet is holding up. Fortunately for him, not bad. The company last raised venture capital—$30 million—in March 2008, from Kleiner Perkins Caufield and Byers, FinTech Global Capital, Sofinnova Ventures, Versant Ventures, InterWest Partners, and Prism VentureWorks. Then the company got a $28 million contract from the National Institutes of Health for a biodefense program in October. That’s certainly not enough to run the kind of ambitious clinical trial program Trius has mapped out, but it gives Stein enough options that no one partner can really back him into a corner to accept lousy deal terms.
“We have cash into next year,” Stein says. “If need be, we can initiate the trials on our own.”