ContraFect Announces Initiation of Pivotal Phase 3 DISRUPT Study of Exebacase as a treatment for Staph aureus Bacteremia, Including Right-Sided Endocarditis
- Category: Proteins and Peptides
- Published on Saturday, 21 December 2019 16:22
- Hits: 1659
Superiority Trial to Confirm Significantly Improved Clinical Outcomes with Exebacase Added to Antibiotics versus Antibiotics alone to treat Methicillin-Resistant Staph aureus (MRSA) Bacteremia
YONKERS, NY, USA I December 20, 2019 IContraFect Corporation (Nasdaq: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, announced the initiation of its Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis.
“This is a seminal milestone for our company as it represents the opportunity to bring a whole new treatment modality to patients suffering and dying from drug-resistant Staph aureus infections – a growing public health crisis where meaningful medical advances have been limited over the last 50 years,” said Roger J. Pomerantz, MD, President, Chief Executive Officer, and Chairman of ContraFect. “We look forward to completing what will be the first pivotal trial designed to demonstrate superiority over the standard of care for Staph bacteremia over the last 60 years.”
“MRSA bacteremia patients treated with exebacase in addition to antibiotics in our Phase 2 trial completed earlier this year had a 43% higher rate of clinical response compared to those who received antibiotics alone at Day 14, which is a remarkable improvement over standard of care,” said Cara Cassino, MD, ContraFect’s Chief Medical Officer and Executive Vice President of Research and Development. “We are excited by the potential for exebacase to improve patient outcomes, decrease mortality, reduce the length of disease-related hospitalizations, and lower the overall financial burden to the healthcare system, as a result MRSA bacteremia.”
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 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 bacteremia patient group (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.
More information about the trial is available at www.clinicaltrials.gov.
ContraFect is a biotechnology company focused on discovering and developing differentiated biologic therapies for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our platform of DLAs, which include lysins and amurin peptides. Lysins are a new class of DLAs which are recombinantly produced antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. Amurin peptides are a new class of DLAs, which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including Pseudomonas aeruginosa (P. aeruginosa), Acinetobacter baumannii, and Enterobacter species. We believe that the properties of our lysins and amurin peptides will make them suitable for targeting antibiotic-resistant organisms, such as methicillin-resistant Staph aureus (MRSA) and P. aeruginosa, which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. We have completed a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis, with our lead lysin candidate, exebacase, which is the first lysin to enter clinical studies in the U.S.