Trius Therapeutics, Inc. announced that the first patient has been dosed in its phase 3 clinical study of the oral dosage form of torezolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The double-blind, active control, pivotal study is designed to compare the efficacy and safety of once-daily oral administration of 200 milligrams of torezolid phosphate for six days of treatment with the efficacy and safety of twice-daily oral administration of 600 milligrams of linezolid (Zyvox) for 10 days of treatment.
The enrolment of the first patient into this study, which is the first ABSSSI study initiated under a Special Protocol Assessment (SPA) under which Trius and the Food and Drug Administration (FDA) have agreed on new early trial endpoints, occurred only three weeks after Trius' initial public offering (IPO). In parallel, Trius also initiated its programme of special population studies with the dosing of the first patient in an adolescent pharmacokinetics study. The results of this study are expected to expand the patient population eligible for phase 3 enrolment.
"Clarity on the clinical and regulatory path afforded by our SPA, which is consistent with the FDA's recently issued draft guidance for ABSSSI, coupled with the capital raised in our IPO have enabled us to move rapidly to initiate our Phase 3 programme," said Jeffrey Stein, Ph.D., president and chief executive officer of Trius. "Historically, the efficacy of antibiotics has been assessed at the end of therapy. We believe that the new early primary efficacy assessment at 48-72 hours after initiation of therapy will allow us to highlight the rapid action of torezolid phosphate, which may offer significant benefits to patients suffering from severe bacterial infections."
The primary efficacy endpoint of the trial is the cessation of spread of infected lesions and absence of fever at 48 to 72 hours following initiation of treatment. Secondary endpoints include the sustained clinical response at the end of therapy visit, the investigator's assessment of clinical response at all visits and clinical success at the post-treatment evaluation visit. A prospective assessment of superiority of torezolid phosphate to linezolid with respect to the primary efficacy endpoint will also be made provided non-inferiority is met. The company intends to conduct the trial in over 100 centres worldwide.
Trius Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious, life-threatening infections. The company's first product candidate, torezolid phosphate, is an IV and orally administered second generation oxazolidinone being developed for the treatment of serious gram-positive infections, including those caused by MRSA.