YONKERS, N.Y., Jan. 10, 2020 (GLOBE NEWSWIRE) -- ContraFect Corporation (CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announced the first patient has been dosed in the Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis.
“We are pleased by the rapid enrollment and dosing of the first patient in the Phase 3 pivotal study of our lead lysin candidate, exebacase, which we believe has the potential to improve clinical outcomes for patients suffering and dying from Staph aureus bacteremia, particularly those infected with difficult to treat methicillin-resistant Staph aureus (MRSA). We are confident in the protocol for the Phase 3 study which aims to be the first pivotal study to demonstrate superiority over standard of care antibiotics alone for the treatment of MRSA bacteremia,” said Cara Cassino, MD, Chief Medical Officer and Executive Vice President of Research and Development of ContraFect. “We believe exebacase and our pipeline of DLA candidates have the potential to be game changers in the fight against drug-resistant pathogens.”
The Phase 3 DISRUPT study of exebacase is a randomized, double-blind, placebo-controlled clinical study conducted in the U.S. to assess the efficacy and safety of exebacase in approximately 350 patients with complicated Staph aureus bacteremia, including right-sided endocarditis. Patients entering the Phase 3 study will be randomized 2:1 to either exebacase or placebo, with all patients receiving standard-of-care antibiotics. The primary efficacy endpoint will be clinical response at Day 14 in patients with MRSA bacteremia, including right-sided endocarditis. Secondary endpoints will include clinical response at Day 14 in the All Staph aureus patients (MRSA and methicillin-sensitive Staph aureus (MSSA)), 30-day all-cause mortality in MRSA patients, and clinical response at later timepoints. The company plans to conduct an interim futility analysis following the enrollment of approximately 60% of the study population.
