Trius Antibiotic Passes Pivotal Study Against Pfizer’s Zyvox
San Diego-based Trius Therapeutics (NASDAQ: TSRX) got some long-awaited good news today for its lead antibiotic in development.
The company said today that its experimental drug, tedizolid phosphate, met the main goal of its pivotal clinical trial by showing it was roughly equal (non-inferior) to Pfizer’s linezolid (Zyvox) when treating acute skin and skin structure infections. The study enrolled 667 patients who were randomly assigned to get a once-daily form of the Trius drug for six days, or a twice-daily course of the Pfizer drug for 10 days. The Trius drug was effective for 79.5 percent of patients, while the Pfizer drug worked for 79.4 percent, Trius said in a statement.
“We are very pleased the trial demonstrated that a 6-day course of once daily oral tedizolid is as efficacious as a 10-day course of twice daily oral linezolid while showing an improved tolerability profile,” said Jeff Stein, Trius’s CEO, in a statement.
More details will be presented at a future scientific meeting, Trius said. But in today’s statement, the company said that 24 percent had adverse events in the study that were drug-related, compared with 31 percent on the existing Pfizer drug. The Pfizer product, approved by the FDA in 2000, generated $1.18 billion in worldwide sales last year. Both it and the Trius product are members of the class of antibiotics known as oxazolidinones. The Trius drug is designed to be a potent new option against some of the more dangerous bacterial infections out there, like MRSA.
Trius shares initially surged on the news, but then fell as the day continued, dropping 12 percent to $5.98 at 10:55 am Eastern time.