Phase III study shows TR 701 (Trius Therapeutics) equivalent to best alternative treatment for ABSSSI

New results from a Phase III study of TR 701 (tedizolid phosphate), from Trius Therapeutics, shows it is as effective as current best treatment for acute bacterial skin and skin structure infections(ABSSSI). The ESTABLISH 1 trial examined the efficacy and safety of 200 mg tedizolid given once a day for six days versus 600 mg linezolid given twice a day for 10 days in 667 patients in North America, Latin America and Europe. The aim was to prospectively measure the new FDA "early response" primary endpoint of cessation of lesion spread and absence of fever 48-72 hours after the first dose. TR 701 achieved the primary and all secondary endpoints in the ESTABLISH 1 trial. Approximately 42 percent of pathogens isolated at baseline in the study were methicillin resistant Staphylococcus aureus (MRSA).

For both tedizolid and linezolid there was good concordance (more than 80%) between the early primary endpoint and late investigator assessed secondary endpoints suggesting that the early response is a good indicator of a sustained clinical response to therapy. In addition, the trial showed that tedizolid had a statistically lower impact on platelets and was associated with a statistically significant lower rate of gastrointestinal (GI) adverse events than linezolid. Results were published in JAMA. See: "Tedizolid Phosphate vs Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infections: The ESTABLISH-1 Randomized Trial" Philippe Prokocimer et al. JAMA. 2013;309(6):559-569. doi:10.1001/jama.2013.241