Last update 21 Jun 2024

Exebacase

Last update 21 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Enzyme

Synonyms

Des-met1-putative phage lysin (streptococcus phage phi891591), produced in escherichia coli, Exebacase (USAN/INN), Lysin cf-301 (streptococcus suis phage)

+ [3]

Target-

Mechanism

Cell wall inhibitors

Therapeutic Areas

Infectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Staphylococcal InfectionsProsthetic joint infection

Inactive Indication

Complicated skin and soft tissue infectionEndocarditisOsteomyelitis+ [3]

Originator Organization

The Rockefeller University

Active Organization

ContraFect Corp.

The Rockefeller University

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (US)

Gene Sequence

Sequence Code 552628766

Source: *****

Clinical Trials associated with Exebacase

NCT04160468 / TerminatedPhase 3

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis

The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE). Patients will be randomized to receive a single intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the investigators based on the protocol.
Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to SoCA to treat S. aureus BSI including IE.

Start Date20 Dec 2019

Sponsor / Collaborator

ContraFect Corp.

EUCTR2016-003059-31-BG / Not yet recruitingPhase 2

A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia) Including Endocarditis

Start Date02 Nov 2017

Sponsor / Collaborator

ContraFect Corp.

NCT03163446 / CompletedPhase 2

A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia) Including Endocarditis

The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia.
CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

Start Date23 May 2017

Sponsor / Collaborator

ContraFect Corp.

100 Clinical Results associated with Exebacase

100 Translational Medicine associated with Exebacase

100 Patents (Medical) associated with Exebacase

Literatures (Medical) associated with Exebacase

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Exebacase in Addition to Standard-of-Care Antibiotics for Staphylococcus aureus Bloodstream Infections and Right-Sided Infective Endocarditis: A Phase 3, Superiority-Design, Placebo-Controlled, Randomized Clinical Trial (DISRUPT)

Article

Author: Lipka-Diamond, Joy ; Kuti, Joseph L ; Wise, Robert A ; Cassino, Cara ; Pomerantz, Roger ; Lachiewicz, Anne M ; Nichols, W Garrett ; Ambler, Jane E ; Moran, Gregory J ; Das, Anita F ; Zervos, Marcus J ; Rupp, Mark E ; Schuch, Raymond ; Fowler, Vance G ; Kaye, Keith S ; Jáuregui-Peredo, Luis

Abstract:

Background:

Novel treatments are needed for Staphylococcus aureus bacteremia, particularly for methicillin-resistant S. aureus (MRSA). Exebacase is a first-in-class antistaphylococcal lysin that is rapidly bactericidal and synergizes with antibiotics.

Methods:

In Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase (DISRUPT), a superiority-design phase 3 study, patients with S. aureus bacteremia/endocarditis were randomly assigned to receive a single dose of intravenous exebacase or placebo in addition to standard-of-care antibiotics. The primary efficacy outcome was clinical response at day 14 in the MRSA population.

Results:

A total of 259 patients were randomized before the study was stopped for futility based on the recommendation of the unblinded Data Safety Monitoring Board. Clinical response rates at day 14 in the MRSA population (n = 97) were 50.0% (exebacase + antibiotics; 32/64) versus 60.6% (antibiotics alone; 20/33) (P = .392). Overall, rates of adverse events were similar across groups. No adverse events of hypersensitivity related to exebacase were reported.

Conclusions:

Exebacase + antibiotics failed to improve clinical response at day 14 in patients with MRSA bacteremia/endocarditis. This result was unexpected based on phase 2 data that established proof-of-concept for exebacase + antibiotics in patients with MRSA bacteremia/endocarditis. In the antibiotics-alone group, the clinical response rate was higher than that seen in phase 2. Heterogeneity within the study population and a relatively small sample size in either the phase 2 or phase 3 studies may have increased the probability of imbalances in the multiple components of day 14 clinical outcome. This study provides lessons for future superiority studies in S. aureus bacteremia/endocarditis.Clinical Trials Registration.NCT04160468

10 Aug 2023·Microbiology spectrum

Rapid bacteriolysis of Staphylococcus aureus by lysin exebacase.

Article

Author: Vila-Farres, Xavier ; Swift, Steven ; DeJonge, Boudewijn ; Ambler, Jane E ; Sauve, Karen ; Oh, Jun ; Schuch, Raymond

Lysins (peptidoglycan hydrolases) are promising new protein-based antimicrobial candidates under development to address rising antibiotic resistance encountered among pathogenic bacteria. Exebacase is an antistaphylococcal lysin and the first member of the lysin class to have entered clinical trials in the United States. In this study, the bacteriolytic activity of exebacase was characterized with time-kill assays, turbidity reduction assays, and microscopy. Three methicillin-susceptible Staphylococcus aureus and three methicillin-resistant S. aureus isolates were tested in time-kill assays over a range of concentrations from 0.25 to 8 × MIC. Exebacase demonstrated a concentration-dependent killing and showed bactericidal activity (≥3 log₁₀ kill achieved relative to the starting inoculum) within 3 h at 1 × MIC against all strains tested. Dose-dependent lysis by exebacase was, furthermore, observed in the turbidity reduction assay, wherein decreases in initial OD₆₀₀ of 50% were observed within ~15 min at concentrations as low as 4 µg/mL. Membrane dissolution, loss of cytoplasmic material, and lysis were confirmed by video and electron microscopy. The demonstrated rapid bacteriolytic effect of exebacase is an important distinguishing feature of this novel modality. IMPORTANCE To guide the development of an investigational new antibacterial entity, microbiological data are required to evaluate the killing kinetics against target organism(s). Exebacase is a lysin (peptidoglycan hydrolase) that represents a novel antimicrobial modality based on degradation of the cell wall of Staphylococcus aureus. Killing by exebacase was determined in multiple assay formats including time-kill assays, wherein reductions of viability of ≥3 log₁₀ colony-forming units/mL were observed within 3 h for multiple different isolates tested, consistent with very rapid bactericidal activity. Rapid reductions in optical density were likewise observed in exebacase-treated cultures, which were visually consistent with microscopic observations of rapid lysis. Overall, exebacase provides a novel antimicrobial modality against S. aureus, characterized by a rapid cidal and lytic activity.

13 Apr 2023·Microbiology spectrum

The Lysin Exebacase Has a Low Propensity for Resistance Development in Staphylococcus aureus and Suppresses the Emergence of Resistance to Antistaphylococcal Antibiotics

Article

Author: Oh, Jun ; Schuch, Raymond ; Warner, Matthew ; Ambler, Jane E

To guide development of an investigational new antibacterial drug, microbiological data are required to understand the potential for development of resistance to the drug in the target organism(s). Exebacase is a lysin (peptidoglycan hydrolase) that represents a novel antimicrobial modality based on degradation of the cell wall of Staphylococcus aureus .

News (Medical) associated with Exebacase

16 Oct 2023

·www.globenewswire.com

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 trialYONKERS, 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. 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, 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). Follow ContraFect on Twitter @ContraFectCorp and LinkedIn. 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, 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: Michael MessingerContraFect CorporationEmail: mmessinger@contrafect.com

Phase 1IND

16 Oct 2023

·www.biospace.com

ContraFect Announces FDA Clearance of CF-370 IND Application to Proceed With Phase 1 Clinical StudyCF-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. 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, 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). Follow ContraFect on Twitter @ContraFectCorpandLinkedIn. 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, 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: Michael Messinger ContraFect Corporation Email: mmessinger@contrafect.com

Phase 1IND

19 Sep 2023

·www.biospace.com

ContraFect to Present at the ASM/ESCMID Joint Conference on Drug Development

YONKERS, New York, Sept. 19, 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 Jane Ambler, Ph.D., the Company’s Vice President of Clinical Microbiology, will be presenting at the ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance, which will be held in Boston, MA from September 19-22, 2023. Dr. Ambler’s presentation will review the current standards for antimicrobial susceptibility testing (AST) for the determination of antibacterial activity of therapeutic agents and the implications for clinical development. She will highlight and discuss various antibiotics in current use and several investigational agents that require a modified AST method, such as the Company’s DLAs. Review and approval of new AST methods by standards development organizations, such as the Clinical and Laboratory Standards Institute (CLSI), is essential. The methodology for susceptibility testing of the Company’s anti-staphylococcal lysin, exebacase, will be described as an illustrative example of a modified AST method recently approved by the CLSI in order to assess the susceptibility of clinical trial isolates in the Company’s Phase 1b/2 study of exebacase currently being conducted in France in patients with chronic prosthetic joint infections (PJI) of the knee. Presentation Details: Presentation Title: Impact of Different Testing Methodologies on Clinical Development Time and Date: Wednesday, September 20, 2023, 9:45 am ET The Company will be presenting two posters describing the initial development of the exebacase MIC method for testing Staphylococci other than Staphylococcus aureus (SoSA) and method verification studies performed to evaluate test performance. These data together with exebacase MIC data of contemporary SoSA isolates generated by testing clinical isolates collected as part of the US SENTRY surveillance program led to the recent approval by CLSI. Poster Title: Exebacase MIC Determination for Staphylococci Other Than Staphylococcus aureus (SoSA) Poster Number: 006 Poster Title: Method Verification of Exebacase MIC Method for Staphylococci Other Than Staphylococcus aureus (SoSA) Poster Number: 007 Presentation Date and Time: September 20, 2023, 3:30 pm – 4:15 pm 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 or coagulase-negative staphylococci (CoNS). Follow ContraFect on Twitter @ContraFectCorpandLinkedIn. 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, ContraFect’s anticipated presentation at the ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance, statements made regarding Dr. Ambler’s presentation, AST, CLSI, the Phase 1b/2 study and Company posters, 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. 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: Michael Messinger ContraFect Corporation Email: mmessinger@contrafect.com

Qualified Infectious Disease ProductClinical Study

100 Deals associated with Exebacase

External Link

KEGG	Wiki	ATC	Drug Bank
D11462	-	-	DB16161

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Right sided infective endocarditis	Phase 3	US	ContraFect Corp.	20 Dec 2019
Staphylococcus aureus bacteraemia	Phase 3	US	ContraFect Corp.	20 Dec 2019
Staphylococcal Infections	Phase 3	-	ContraFect Corp.	-
Staphylococcal Infections	Phase 3	-	The Rockefeller University	-
Prosthetic joint infection	Phase 2	FR	ContraFect Corp.	03 Apr 2023
Endocarditis	Phase 2	BE	ContraFect Corp.	23 May 2017
Endocarditis	Phase 2	BG	ContraFect Corp.	23 May 2017
Endocarditis	Phase 2	CL	ContraFect Corp.	23 May 2017
Endocarditis	Phase 2	CZ	ContraFect Corp.	23 May 2017
Endocarditis	Phase 2	FR	ContraFect Corp.	23 May 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04160468 (DISRUPT, CTgov)	Phase 3	Staphylococcus aureus bacteraemia \| Right sided infective endocarditis	259	exebacase (Exebacase + SoCA)	fawacjyhpc(uujacqioin) = tcfwusgerx rrfjdcrchg (licydaqjge, rptkwbgbnl - qizwbsukww) View more	-	18 Oct 2023
				placebo (SoCA Alone)	fawacjyhpc(uujacqioin) = yocgttbdvp rrfjdcrchg (licydaqjge, kocsvyduon - covgjqilao) View more
Corporate Publications Manual	Not Applicable	Prosthetic joint infection	8	Exebacase (patients suffering their first episode of CoNS knee PJI)	kwkaadpihb(deywbprred) = xahkyhtsmc ebplfqdyul (evzigoftuk ) View more	Positive	12 Sep 2022
				Exebacase (patients suffering from a complex episode of multi-drug resistant CoNS knee PJI)	kwkaadpihb(deywbprred) = wqsvgesupo ebplfqdyul (evzigoftuk ) View more
NCT03163446 (CTgov)	Phase 2	Staphylococcus Aureus Infections \| Staphylococcus aureus bacteraemia \| Endocarditis	121	CF-301 (CF-301)	hvetwspzyd(gfnjkxtaui) = rkdolbatlw zqqpadtusa (aapbpwnrao, lkrhqthmte - jwmnvvpphz) View more	-	08 Oct 2021
				Placebo (Placebo)	hvetwspzyd(gfnjkxtaui) = yehidtkxqu zqqpadtusa (aapbpwnrao, pzgihmmnuq - vhuwafdwkg) View more
NCT04160468 (Pubmed \| J Clin Microbiol)	Phase 3	Staphylococcus Aureus Infections \| Staphylococcus aureus bacteraemia \| Right sided infective endocarditis	259	Exebacase	nofiaafgfb(jyulaxeorl) = btaxnuxksg iqwbtndubv (cylkkfnjzs )	-	28 Apr 2021
NCT03163446 (Pubmed \| J Clin Invest)	Phase 2	Sepsis	121	Exebacase + antibiotics	fuikenpxmn(vocxvvoxso) = bnijccwhcg jypmstcfsx (tindugmfhj ) View more	Positive	01 Jul 2020
				Antibiotics alone	fuikenpxmn(vocxvvoxso) = quxokkfalc jypmstcfsx (tindugmfhj ) View more

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