CFRX ContraFect Corporation

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 as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, announces today the presentation of data showing significant activity of its direct lytic agents against the most drug-resistant Gram-negative pathogens, including Pseudomonas aeruginosa (P. aeruginosa), Klebsiella pneumoniae (K. pneumoniae) and Burkholderia spp, at ASM Microbe 2023 held from June 15-19, 2023 in Houston, Texas.

“The data presented at ASM Microbe is quite powerful. Our ability to demonstrate the potent efficacy of CF-370 in animals infected with lethal strains of Pseudomonas, Klebsiella and Acinetobacter holds great promise for the clinical utility of CF-370 in patients with either hospital-acquired or ventilator-associated pneumonia (HAP/VAP), including patients with compromised immune systems from cancer, age, or other comorbidities,” said Roger J. Pomerantz, MD, President, Chief Executive Officer, and Chairman of ContraFect. “Along with the new data showing our ability to engineer agents with potent activity against extremely difficult to treat species of Burkholderia and Yersinia, I believe the ContraFect platform represents one of the last remaining paths towards conquering antimicrobial resistance for the foreseeable future.”

All meeting presentations referenced below are available on the ContraFect website.

ASM Microbe 2023 Presentations:

Presentation Title:   Efficacy of lysin CF-370 in addition to amikacin or meropenem in a neutropenic rabbit lung infection model caused by Klebsiella pneumoniae

In the first study using this challenging model of pulmonary infection, neutropenic animals were infected with a susceptible strain of K. pneumoniae and treated with dose regimens of amikacin and CF-370 administered alone and CF-370 administered as both a single dose and in multiple doses in addition to amikacin. Both dose regimens of CF-370 in addition to amikacin significantly reduced bacteria counts compared to all other treatment groups (p≤0.0001).

In the second study using the same model, neutropenic animals were infected with an extensively drug-resistant (XDR) strain of K. pneumoniae obtained from the Center for Disease Control and Food and Drug Administration Antibiotic Resistance Isolate Bank and treated with dose regimens of meropenem and CF-370 administered alone and CF-370 administered in multiple doses in addition to meropenem. The only treatment arm to achieve a significant reduction in bacterial density occurred with the administration of multiple doses of CF-370 in addition to meropenem as compared to all other treatment arms (p≤0.0002).

The results of this study reproduce the efficacy seen in previously released data presented at ECCMID 2023 further demonstrating the bactericidal power of CF-370 against XDR strains of Gram-negative pathogens. In the previous study using the same model, CF-370 achieved the most significant reduction in bacterial density of XDR P. aeruginosa when administered in multiple doses in addition to amikacin as compared to all other treatment arms (p=0.0018 vs. amikacin alone, p=0.0083 vs. CF-370 alone, and p=0.0279 vs. CF-370 single dose + amikacin).

Presentation Title: Engineered lysins with potent in vitro activity against Burkholderia spp. and Yersinia pestis

After multiple in vitro studies, including the determination of minimal inhibitory concentration (MIC) values, time-kill assays, fluorometric uptake assays for N-Phenyl-1-naphthylamine (NPN) to demonstrate the disruption of the outer membrane of Gram-negative bacteria and testing for hemolysis of human red blood cells, the Company has selected 18 lysins with highly potent and extremely rapid bactericidal activity against Burkholderia spp and Yersinia pestis and, importantly, no hemolytic activity, for further preclinical development and selection for progression into animal efficacy studies.   

Presentation Title:   PK-PD relationships and PK drivers of efficacy of the novel antibacterial lysin CF-370 in a rabbit pneumonia model caused by a carbapenem-resistant Pseudomonas aeruginosa

In preparation for the study of CF-370 in human clinical trials, the Company studied the relationship between CF-370 exposure and efficacy in a rabbit pneumonia model caused by a carbapenem-resistant P. aeruginosa. Corroborating the results seen in previous animal studies, CF-370 administered as a single dose of 5, 10, 20 or 30 mg/kg or fractionated doses of 2.50, 3.33, 6.67 and 10 mg/kg, all in addition to meropenem, achieved a significant reduction in bacterial density compared to either meropenem or CF-370 administered alone (p≤0.05). The Company also determined the appropriate PK target to drive clinical efficacy for CF-370 when administered in addition to standard of care antibiotics.

Presentation Title: Efficacy of single and daily dose of lysin CF-296 in addition to daptomycin in a rat methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis model

In this rat study, CF-296 was delivered systemically into the jugular vein (both with and without daptomycin) to treat osteomyelitis resulting from methicillin-resistant Staphylococcus aureus (MRSA) implantation. While all treatment groups showed activity compared to a placebo control, the greatest reduction in the concentration of bacteria colonies was demonstrated with CF-296 administered daily in addition to daptomycin (p=0.0003).

The results of this study reinforce previously released data demonstrating the power of both CF-296 and exebacase when delivered locally in the rabbit osteomyelitis model. The demonstrated ability of the Company’s antistaphylococcal lysins to achieve no detectable levels of bacteria in animals underpins the ongoing Phase 1b/2 study of exebacase in patients with chronic prosthetic joint infections (PJI) of the knee due to Staphylococcus aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS).

About 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 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, Pseudomonas aeruginosa and Acinetobacter baumannii, which can cause serious infections such as bacteremia and pneumonia. We are 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).

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Forward-Looking Statements

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, the ASM Microbe presentations, statements made by Dr. Pomerantz, the data presented and statements made regarding the same, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, whether direct lytic agents, including CF-370, show significant activity and potency against the most drug resistant Gram-negative pathogens, whether the ContraFect platform represents one of the last remaining paths towards conquering antimicrobial resistance, whether ContraFect will address life-threatening infections using therapeutic candidates from 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, 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 Phase 1b/2 trial in France. 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 Annual Report on Form 10-K for the year ended December 31, 2022 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:

Michael MessingerContraFect CorporationEmail: mmessinger@contrafect.com