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
Data from Single Pediatric Patient Highlights that FDA-Designated Breakthrough Therapy Exebacase May be a Beneficial Adjunctive Therapy for Severe MRSA Infections in Children
YONKERS, N.Y., 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 lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, announces today the recent publication of a case study report highlighting the potential of its first investigational direct lytic agent, exebacase, to treat methicillin-resistant Staphylococcus aureus (MRSA) bacteremia in a pediatric population. The case report was published in the peer-reviewed Clinical Infectious Diseases, a journal of the Infectious Disease Society of America (IDSA).
“These data, although representing 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 help address these life-threatening infections,” stated Cara Cassino, M.D., Chief Medical Officer and Executive Vice President of Research and Development of ContraFect Corporation. “We were pleased to learn of the positive outcome of this patient and we will continue to progress our critically important therapeutics as rapidly but as safely as possible.”
The results, published ahead-of-print, describe the pharmacokinetics (PK) and dosing of the first infant to receive exebacase. The patient, a previously healthy 5-month-old male infant, presented to Duke University Hospital for evaluation of jerking movements and inability to sit independently. Following a full evaluation, it was determined that he had a culture confirmed life-threatening MRSA infection with multi-organ involvement, included a left temporal subdural empyema, a retropharyngeal abscess, and right-sided endocarditis. Despite targeted therapy, optimized dosing, and attempts at source control, clearance of bacteremia and clinical improvement was not achieved with standard of care (SOC) antibiotics alone. The treating physician obtained authorization from the U.S. Food and Drug Administration (FDA) to use exebacase under an emergency individual patient investigational new drug application and the patient subsequently received one 3 mg dose of exebacase on hospital day 7. The patient continued to receive SOC anti-staphylococcal antibiotics throughout the hospital stay. Blood cultures became sterile on hospital day 12. The patient had ongoing clinical improvement and serial echocardiograms noted no evidence of heart valve vegetation on hospital day 40. The patient was discharged, without the need for additional surgery.
This report represents a single patient, and it is difficult to know with certainty if clinical improvement was due to exebacase directly, extended SOC antibiotic therapy or the combined effect of both. Nevertheless, exebacase is a novel DLA that may be a beneficial adjunctive therapy for MRSA bacteremia including right-sided endocarditis in children. Future clinical trials are planned to confirm dosing and efficacy in the pediatric population.
About Methicillin-Resistant Staphylococcus aureus (MRSA):
MRSA is a result of Staph aureus infections that are difficult to treat because of 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, adverse events, and increasing resistance. New therapies for MRSA bacteremia are greatly needed.
About Exebacase (CF-301):
Exebacase is an anti-staphylococcal recombinantly-produced lysin (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 lysin to enter clinical studies in the U.S. and was 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.
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 clinical responder rate at Day 14 in patients treated with exebacase was nearly 43-percentage points higher than in patients treated with SOC antibiotics alone (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 rate of clinical response, MRSA-infected patients treated with exebacase showed a 21-percentage point reduction in 30-day all-cause mortality (p=0.056), a four-day lower median length of hospital stay and meaningful reductions in hospital readmission rates.
Exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia. Exebacase was licensed from The Rockefeller University and is being developed at ContraFect.
ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. 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 novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including 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 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. Exebacase, currently being studied in a pivotal Phase 3 clinical study, was 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.
This press release contains, and our officers and representatives may make from time to time, “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding: the potential for exebacase 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 regarding exebacase and clinical improvement, whether exebacase may be a beneficial adjunctive therapy, planned pediatric clinical trials, whether MRSA bacteremia causes significant morbidity and mortality, whether exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia, whether ContraFect will address life-threatening infections using its DLA platform, whether 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, whether amurins are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, and whether the properties of ContraFect’s lysins and amurins will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa. Forward-looking statements are statements that are not historical facts, nor assurances 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 relate to the future, 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 any adverse events related to the discovery, development and commercialization of ContraFect’s product candidates such as unfavorable clinical trial results, insufficient supplies of drug products, the lack of regulatory approval, or the unsuccessful attainment or maintenance of patent protection and other important risks detailed under the caption “Risk Factors” in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations 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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Source: ContraFect Corporation
Released December 20, 2021