Trius Therapeutics has announced the initiation of a Phase III clinical study of the oral form of torezolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The study will be an active control, double-blind, pivotal trial which will compare the safety and efficacy of 200mg of torezolid phosphate, once-daily dose for six days, with safety and efficacy of 600mg of linezolid (Zyvox), twice-daily dose for ten days.
The study had been initiated under a Special Protocol Assessment (SPA), after Trius and the Food and Drug Administration (FDA) reached an agreement upon new trial endpoints.
The primary efficacy endpoint of the study will be cessation in the spread of infected lesions and absence of fever at 48-72 hours, after the initiation of treatment.
Secondary endpoints include sustained clinical response at the end of therapy visit, clinical success at the post-treatment evaluation visit, and investigator’s evaluation of clinical response during all visits.
If non-inferiority is met, a prospective assessment of superiority of phosphate over linezolid with respect to the primary efficacy endpoint will be done.
The study will be conducted at over 100 centres across the world.