Trius reports positive data from ESTABLISH 2 Phase 3 study of Tedizolid
Trius Therapeutics has reported positive results from ESTABLISH 2 Phase 3 study of Tedizolid phosphate (TR-701) against severe skin infections such as acute bacterial skin and skin structure infections (ABSSSI), including methicillin resistant Staphylococcus aureus (MRSA).
Tedizolid met all primary and secondary efficacy outcomes designated by the FDA and EMA in the ESTABLISH 2 intravenous (IV) to oral transition study.
Trius president and chief executive officer Jeffrey Stein said, "We are committed to responding to the needs of patients and physicians worldwide for new and effective antibiotics. Looking ahead, we intend to file our NDA for tedizolid as well as initiate a Phase 3 study of tedizolid in patients with severe pneumonia during the second half of this year."
The randomized, double-blind study conducted at 95 sites across North and South America, Europe, Australia, New Zealand and South Africa enrolled 666 ABSSSI patients.
The primary endpoint of Tedizolid demonstrating non-inferiority (10% NI margin) to linezolid as measured by a 20% or greater reduction in lesion area at 48 to 72 hours after the first infusion of study drug was met.
All secondary efficacy endpoints measured at both the end of therapy and post treatment evaluations were also met in the study.
Both tedizolid and linezolid were well tolerated in ESTABLISH 2 study.
A 20.5% of tedizolid patients reported drug-related treatment emergent adverse events such as gastrointestinal adverse events compared to 24.8% of linezolid treated patients.