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Positive Phase III Results for Tedizolid in Severe Skin Infections
Study shows non-inferiority versus linezolid (Mar. 25)
Results have been announced from the ESTABLISH 2 trial, a phase III clinical study of tedizolid phosphate (TR-701, Trius Therapeutics) for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).
The new trial was an intravenous (IV)-to-oral transition study of tedizolid. A previous phase III study, ESTABLISH 1, tested the drug’s oral dosage form.
The randomized, double-blind, placebo-controlled ESTABLISH 2 trial enrolled a total of 666 patients with ABSSSI in North and South America, Europe, Australia, New Zealand, and South Africa. The patients received either 200 mg of tedizolid once a day for 6 days plus 4 days of placebo (n = 332), or 600 mg of linezolid (Zyvox, Pfizer) twice a day for 10 days (n = 334). The patients initially received the IV dosage form of either tedizolid or linezolid, with the option of switching to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day of treatment.
Tedizolid met its primary endpoint of non-inferiority to linezolid, as measured by a 20% or greater reduction in the lesion area at 48 to 72 hours after the first infusion of study drug. A 20% or greater decrease from baseline in lesion area was achieved by 85.2% of the tedizolid group versus 82.6% of the linezolid group.
Moreover, 88.0% and 87.7% of the tedizolid and linezolid groups, respectively, met the secondary endpoint of a clinical response at 7 to 14 days after the end of therapy.
Both tedizolid and linezolid were generally well tolerated. Drug-related treatment-emergent adverse events (TEAEs) were reported in 20.5% of tedizolid-treated patients versus 24.8% of linezolid-treated patients. Gastrointestinal adverse events were the most commonly reported TEAEs (16.0% in the tedizolid group vs. 20.5% in the linezolid group).
Data from the ESTABLISH 1 study, which tested the oral dosing of tedizolid, were published in JAMA in February 2013.
Source: Trius Therapeutics; March 25, 2013.