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 … Next Page »