Shares of Trius Therapeutics ($TSRX) surged on the news that its late-stage antibiotic tedizolid closely matched Zyvox (linezolid) in one of a series of pivotal studies, helping nail down support for its case that the experimental antibiotic is just as good as the blockbuster with a once-daily dosing schedule over a shorter period. The antibiotic hit its primary endpoint for acute bacterial skin and skin structure infections as well as all secondary goals. The news helped push up Trius shares a little more than 10% this morning in early trading.
Trius also bolstered its case that its antibiotic is safer than the mainstay product, which had worldwide sales of $1.2 billion in 2010. Investigators reported that about one in four of the tedizolid patients experienced "drug-related treatment emergent adverse events" compared to 31% of linezolid treated patients. Gastrointestinal adverse events were the most commonly reported events and were statistically significantly lower in tedizolid patients than in linezolid patients.
"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 Jeffrey Stein, Ph.D., the CEO of Trius. "We look forward to presenting the detailed results of this study, the first Phase 3 study to be conducted under the new regulatory paradigm, both in a peer reviewed journal and at a major conference in 2012."
Trius is one of a handful of biotechs like Rib-X, Tetraphase and Achaogen which are pushing ahead with experimental antibiotics despite a tough regulatory environment and years of neglect by Big Pharma. Last July Bayer Pharma stepped up with a $94 million deal for the antibiotic, paying $25 million upfront for the Asian, African and Latin American rights to tedizolid (formerly torezolid) while the biotech held on to the key U.S. and European rights.
- here's the Trius release
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