Compassionate Use Case Study Demonstrating the Potential of Investigational Direct Lytic Agent Exebacase to Treat MRSA Bacteremia in Pediatric Populations Published in Clinical Infectious Diseases
Single Pediatric Patient Data Highlights FDA-Designated Breakthrough Therapy Exebacase May Be a Beneficial Adjunctive Therapy for Severe MRSA Infections in Children
YONKERS, NY, Dec. 20, 2021 (GLOBE NEWSWIRE) — ContraFect Corporation (Nasdaq: CFRX), a late clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysines and amurine peptides, as novel medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announces the recent publication of a case study report highlighting the potential of the first direct lytic agent under investigation, exebacase, for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) bacteremia in a pediatric population. The case report is published in the peer-reviewed Clinical Infectious Diseases, a journal of the Infectious Disease Society of America (IDSA).
“These data, while pertaining to a single pediatric patient, provide a compelling case for further evaluation of exebacase in pediatric populations. These findings are especially important given the limited treatment options available to address these life-threatening infections,” said Cara. Cassino, MD, Chief Medical Officer and Executive Vice President of Research and Development, ContraFect Corporation, said: “We were delighted to hear of the positive outcome of this patient and we will continue our critical therapies as quickly and safely as possible.”
The results, published pre-press, describe the pharmacokinetics (PK) and dosage of the first infant to receive exebacase. The patient, a previously healthy 5-month-old male baby, presented to Duke University Hospital for evaluation for jerking movements and inability to sit independently. After a full evaluation, he was determined to have a culture-confirmed life-threatening MRSA infection involving multiple organs, including left temporal subdural empyema, retropharyngeal abscess, and right-sided endocarditis. Despite targeted therapy, optimized dosing and attempts at source control, bacteremia clearance and clinical improvement were not achieved with standard of care (SOC) antibiotics alone. The treating physician received approval from the U.S. Food and Drug Administration (FDA) to use exebacase as part of an urgent application for a new investigational drug in an individual patient and the patient then received one dose of 3 mg exebacase on hospital day 7. The patient continued to take SOC anti-staphylococcal antibiotics throughout the hospital stay. Blood cultures were sterile on hospital day 12. The patient had continued clinical improvement and serial echocardiograms showed no evidence of valvular heart vegetation on hospital day 40. The patient was discharged, without the need for additional surgery.
This report concerns a single patient and it is difficult to know with certainty whether clinical improvement was due to exebacase direct, extended SOC antibiotic therapy, or the combined effect of both. Nevertheless, exebacase is a new DLA that may be a beneficial adjunct therapy for MRSA bacteremia, including right-sided endocarditis in children. Future clinical studies are planned to confirm posology and efficacy in the pediatric population.
About methicillin resistant Staphylococcus aureus (MRSA):
MRSA is the result of Staph aureus infections that are difficult to treat due to bacterial resistance to SOC antibiotics. MRSA bacteremia in particular causes significant morbidity and mortality. Treatment with SOC antibiotics alone is difficult due to increasing virulence, limited drug penetration, side effects and increasing resistance. New therapies for MRSA bacteremia are desperately needed.
About Exebacase (CF-301):
Exebacase is a recombinantly produced anti-staphylococcal-produced lysine (cell wall hydrolase enzyme) with potent bactericidal activity against Staph aureus, a major cause of bloodstream infections (BSIs), also known as bacteremia. It is the first lysine to enter clinical trials in the US and has been declared a Breakthrough Therapy designation by the FDA for the treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics.
Exebacase is currently being studied in the Phase 3 DISRUPT superiority design study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis. In the company’s Phase 2 study of exebacase, a pre-specified analysis of MRSA-infected patients showed that the rate of clinical response at Day 14 in patients treated with exebacase was nearly 43 percentage points higher than in patients treated with SOC alone. antibiotics were treated (74.1). % for patients treated with exebacase compared to 31.3% for patients treated with SOC antibiotics alone (p=0.010)). In addition to the higher clinical response, MRSA-infected patients treated with exebacase showed a 21 percentage point reduction in all-cause mortality over 30 days (p=0.056), a four-day lower median length of stay and meaningful reduction in hospital readmission rates .
Exebacase has the potential to be a first-class treatment for Staph aureus bacteremia. Exebacase is licensed by The Rockefeller University and is being developed at ContraFect.
ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysines and amurine peptides, as novel medical modalities for the treatment of life-threatening, antibiotic-resistant infections. Worldwide, an estimated 700,000 deaths are attributed to antibiotic-resistant infections each year. We intend to address life-threatening infections using our therapeutic product candidates from our platform of DLAs, including lysines and amurine peptides. Lysines are a new class of DLAs produced recombinantly and are antimicrobial proteins with a novel mechanism of action related to rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. Amurine peptides are a new class of DLAs that exhibit broad spectrum activity against a wide variety of antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. We believe that the properties of our lysines and amurine peptides will make them suitable for combating antibiotic-resistant organisms, such as 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 lysine candidate, exebacase, the first lysine to enter clinical trials in the US. Exebacase, currently being studied in a pivotal Phase 3 clinical trial, has been granted Breakthrough Therapy designation by the FDA for the treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics.
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This press release contains, and our officers and representatives may from time to time make “forward-looking statements” within the meaning of the US federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “believe,” “expect,” “anticipate,” “estimate,” “intends ”, “plans”, “potential”, “promise” or similar references to future periods.Examples of forward-looking statements in this press release include, without limitation, statements regarding: exebacase’s potential to treat MRSA bacteremia in pediatric populations , ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, statements about exebacase and clinical improvement, whether exebacase could be a beneficial adjunct therapy, planned clinical trials in children, or MRSA bacteremia causes significant morbidity and mortality, whether exebacase has the potential to be a first-class treatment for Staph aureus bacteremia, whether ContraFect will tackle life-threatening infections using its DLA platform, whether lysines are a new class of DLAs produced recombinantly, antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics, whether amurines are a new class of DLAs that exhibit broad spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, and whether the properties of ContraFect’s lysines and amurines will make them suitable for the combating antibiotic-resistant organisms, such as MRSA and P aeruginosa. Forward-looking statements are statements that are neither historical facts nor guarantees of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements are forward-looking, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including the occurrence of adverse events related to the discovery, development and commercialization of ContraFect’s product candidates, such as adverse clinical trial results, insufficient drug delivery, lack of regulatory approval, or failure to successfully obtain or maintain patent protection, and other significant risks described under the heading “Risk Factors” in ContraFect’s filings with the Security and Exchanges Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include our ability to develop treatments for resistant infectious diseases. Any forward-looking statement by ContraFect in this press release is based only on information currently available and speaks only as of the date made. Except as required by applicable law, ContraFect expressly disclaims any obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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