ContraFect Announces FDA Clearance of CF-370 IND Application to Proceed With Phase 1 Clinical Study
CF-370 is the first engineered lysin therapeutic targeting Gram-negative pathogens allowed to enter a human trial
YONKERS, N.Y., Oct. 16, 2023 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, today announces that the U.S. Food and Drug Administration (FDA) has notified the company that it has completed the safety review of its Investigational New Drug (IND) application for CF-370 for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), and concluded that the company may proceed with its Phase 1 clinical study.
This milestone is significant for ContraFect and historic in the field of non-traditional antibacterial therapies, as CF-370 will be the first engineered lysin therapeutic targeting Gram-negative pathogens to enter a human clinical trial. CF-370 has demonstrated potent in vitro activity against Pseudomonas aeruginosa (P. aeruginosa), Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli (E. coli) and Enterobacter cloacae and across numerous animal models of pneumonia, including efficacy against multi-drug resistant strains. ContraFect is a global innovator in the discovery and development of DLAs, leading the field with an intellectual property portfolio which includes thirty (30) U.S. patents, one hundred and fifty-four (154) issued foreign patents and two hundred and forty-six (246) pending U.S. and international patent applications. The company’s discovery platform and functional expression library are designed to enable the construction and identification of novel therapeutic proteins that can penetrate the outer membrane of Gram-negative bacteria, resulting in lysis and prokaryotic cell death. CF-370 represents the first product candidate to be developed using the company’s proprietary technologies.
“We are very pleased with the FDA’s clearance of our IND application for CF-370. This is a huge achievement for the company with enormous potential to arm our hospitals and clinicians with a truly new agent to address infections caused by antibiotic-resistant Gram-negative bacteria,” said Roger J. Pomerantz, MD, President, Chief Executive Officer, and Chairman of ContraFect. “I look forward to working with our dedicated team at ContraFect and our investigators to initiate the Phase 1 clinical trial later this year.”
HABP/VABP are serious, potentially life-threatening infections that are associated with high mortality and substantial morbidity. New therapies to treat these infections are critically important to meet patient needs, particularly because of increasing antimicrobial resistance. HABP/VABP occurs in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. P. aeruginosa, Acinetobacter species, Klebsiella species, E. coli and Enterobacter species are the most commonly implicated Gram-negative pathogens in HABP/VABP infections. Infections caused by multi-drug resistant (MDR) and extensively-drug resistant (XDR) Gram-negatives, particularly MDR P. aeruginosa, and carbapenem-resistant Acinetobacter and Enterobacteriaceae, are associated with significant mortality and are becoming increasingly difficult-to-treat. According to data from the United States Centers for Disease Control and Prevention (CDC), HABP/VABP are currently the most common type of hospital-acquired infections in acute care hospitals and are a significant issue in patients in the intensive care unit (ICU)1.
1 United States Centers for Disease Control and Prevention, 2021 National and State HAI Progress Report, Acute Care Hospitals. The HAI Progress Report includes data from 3,917 facilities reporting to the National Healthcare Safety Network covering 36.3 million hospital admissions.
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 therapeutic product candidates generated from our proprietary platform of DLAs. 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. We believe that the properties of our lysins and amurin peptides will make them suitable for targeting antibiotic-resistant organisms, such as MRSA, P. aeruginosa and Acinetobacter baumannii, which can cause serious infections such as bacteremia and pneumonia. The Company is currently enrolling patients in a Phase 1b/2 of exebacase being conducted in France in the setting of an arthroscopic debridement, antibiotics, irrigation, and retention (DAIR) procedure in patients with chronic prosthetic joint infections (PJI) of the knee due to Staphylococcus aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS). The Company is also proceeding with the initiation of a Phase 1 trial for its second intravenous (IV) antibacterial agent, CF-370, for the potential treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
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, whether CF-370 is the first engineered lysin to enter a human trial, statements made regarding the FDA letter and its review process, the timing of the initiation of the Phase 1 study and whether the company will move forward with it, whether this milestone is historic in the field of non-traditional antibacterial therapies, whether CF-370 has demonstrated potent in vitro activity against P. aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, E. coli, Enterobacter cloacae and across numerous animal models of pneumonia, including efficacy against multi-drug resistant strains, whether the company is leading the field with its intellectual property portfolio, whether CF-370 is the first product candidate developed using the company’s proprietary technologies, comments made by Dr. Pomerantz, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, whether ContraFect will address life-threatening infections using therapeutic candidates from its proprietary 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, whether the properties of ContraFect’s lysins and amurins will make them suitable for targeting antibiotic-resistant organisms, such as MRSA, Pseudomonas aeruginosa and Acinetobacter baumannii and statements made regarding the exebacase Phase 1b/2 trial in France and the CF-370 Phase 1 trial in the US. 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, without limitation, that ContraFect has and expects to continue to incur significant losses, ContraFect’s need for additional funding, which may not be available, 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, changes in management may negatively affect ContraFect’s business and other important risks detailed under the caption “Risk Factors” in ContraFect's Quarterly Report on Form 10-Q for the year ended June 30, 2023 and its other filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. 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.
Investor Relations Contacts:
Released October 16, 2023