04/16/2019 | Press release | Distributed by Public on 04/16/2019 04:40
ContraFect Corporation (NASDAQ: CFRX) today announced that new data from its Phase 2 clinical trial of exebacase for the treatment of Staphylococcus aureus (Staph aureus) bacteremia including endocarditis was presented by Vance G. Fowler, M.D., Professor of Medicine in the Division of Infectious Diseases, Duke University at a late-breaker session at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The oral presentation, titled 'Exebacase (Lysin CF-301) Improved Clinical Responder Rates In Methicillin Resistant Staphylococcus Aureus (MRSA) Bacteremia Including Endocarditis Compared To Standard Of Care Antibiotics Alone In A First-in-Patient Phase 2 study,' reported new data demonstrating clinically meaningful increases in clinical responder rates in the pre-specified MRSA subgroup treated with exebacase, including a 22.9% higher responder rate at Day 7 and a 16.9% higher responder rate at Test of Cure, compared to MRSA patients treated with standard of care antibiotics (SOC) alone. Pre-specified analyses of data from the overall population also showed that patients with complicated bacteremia had a 20.3% higher clinical responder rate with exebacase compared to those who received SOC alone (78.6% and 58.3% for the exebacase + SOC and SOC alone groups, respectively).
'We are excited by the impressive results observed in the pre-specified MRSA subgroup treated with exebacase. MRSA bloodstream infections remain an area of extremely high unmet medical need with few treatment options, and our Phase 2 superiority design study demonstrated a clinical responder rate of 74.1% at Day 14 in the MRSA subpopulation, which represents a 42.8% improvement over standard of care antibiotics alone,' said Dr. Roger J. Pomerantz, President and Chief Executive Officer, and Chairman of ContraFect. 'We are also pleased to see the 20.3% higher clinical responder rate at Day 14 among all complicated bacteremia patients treated with exebacase compared to those treated with SOC alone, further validating our belief that exebacase may play a critical role in the treatment of complicated bacteremia, as well as resistant infections such as MRSA.'
Cara Cassino, M.D., Chief Medical Officer and Executive Vice President of Research and Development at ContraFect, said, 'We are very encouraged by these results which strongly suggest the potential for exebacase to offer substantial clinical benefit to patients with MRSA bloodstream infections, and we look forward to advancing exebacase into a definitive Phase 3 trial.'
The Phase 2 clinical trial of exebacase is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial in patients with Staph aureus bacteremia including endocarditis. This superiority design study compared the responder rates with exebacase administered on a background of antibiotic therapy to antibiotics alone. The primary efficacy endpoint in this study was the clinical responder rate at Day 14 in patients with Staph aureus who received study drug. Clinical responder rates at Day 7, End of Treatment (EOT) and Test of Cure (TOC) were evaluated in the same population as secondary efficacy endpoints. The clinical responder rates at Day 7, Day 14, EOT and TOC were 71.8%, 70.4%, 62.0% and 54.9%, respectively, for patients treated with exebacase compared to 68.9%, 60.0%, 62.2% and 55.6%, respectively for patients treated SOC alone.