ContraFect to Present New Late Breaking Phase 2 Exebacase Data on Rapid Symptom Resolution Among Patients with Staphylococcus aureus Bacteremia at IDWeek™ 2021

Rhea-AI Summary

ContraFect Corporation (CFRX) announced the presentation of positive clinical data on exebacase at IDWeek 2021. A completed Phase 2 study demonstrated that exebacase significantly improved clinical responder rates by nearly 43 percentage points compared to standard-of-care antibiotics for Staphylococcus aureus bacteremia. Additionally, exebacase showed a 21 percentage point reduction in 30-day mortality. Exebacase is currently under evaluation in the pivotal Phase 3 DISRUPT study, potentially establishing it as a first-in-class treatment for this serious condition.

Positive

• Exebacase demonstrated a clinical responder rate of 74.1% in MRSA patients vs. 31.3% for standard care (p=0.010).
• 21 percentage point reduction in 30-day all-cause mortality in MRSA patients (p=0.056).
• Exebacase is entering Phase 3 DISRUPT study for Staphylococcus aureus bacteremia.

Negative

• None.

Data Being Presented Demonstrates Directly Positive Clinical Utility and Furthers the Understanding of Exebacase in Treating Staphylococcus aureus Bacteremia, Including Multidrug-Resistant MRSA

YONKERS, N.Y., Sept. 29, 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 that the Company has been selected to deliver a Late Breaker oral presentation on the rapid symptom resolution in adult patients with Staphylococcus aureus (Staph aureus) bacteremia who were treated with exebacase in the completed Phase 2 study.

The company will also present the results of a recently conducted microbiologic surveillance study of the activity of exebacase (CF-301) against Staph aureus specimens from patients with bacteremia in the United States, including multidrug-resistant Methicillin-resistant Staph aureus (MRSA) species.

These findings are all being presented at IDWeek^TM 2021, being held from September 29 through October 3, in San Diego, CA.

IDWeek^TM 2021 Presentation Details:

Oral Late-Breaker presentation:

Abstract: Exebacase Shows Rapid Symptom Resolution in a Phase 2 Study in Adult Patients with Staphylococcus aureus bacteremia
Session: Late Breaker Abstracts
Date: Saturday October 2, 2021
Session Time: 1:15 PM – 3:00 PM
Presenting Author: Cara Cassino, M.D., Chief Medical Officer and Executive Vice President of Research & Development, ContraFect

Poster presentation:

Session: Novel Agents
Poster Title: In vitro Activity of Exebacase (CF-301) against Staphylococcus aureus Causing Bacteremia in the United States, Including Multidrug-resistant Subsets 
Poster ID: 1059
Presenting Author: Rodrigo Mendes, Ph.D. (JMI Laboratories)

All posters will be available to meeting registrants on demand and available through the IDWeek website. Following the meeting, the presentation abstracts and poster will be available on the ContraFect website.

About Exebacase (CF-301):

Exebacase is a 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. 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 is currently being studied in the Phase 3 DISRUPT superiority design study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis.

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.

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 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.

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, statements regarding: exebacase data and its clinical utility, the presentations, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, 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.

Investor Relations Contacts:

Michael Messinger
ContraFect Corporation
Tel: 914-207-2300
mmessinger@contrafect.com

Jules Abraham
CORE IR
Tel: 917-885-7378
Julesa@coreir.com

FAQ

What are the Phase 2 study results for exebacase presented by ContraFect?

The Phase 2 study showed that exebacase achieved a clinical responder rate of 74.1% in MRSA patients, significantly higher than the 31.3% for standard care.

When did ContraFect present the exebacase results?

The results were presented at IDWeek 2021 from September 29 to October 3.

What is the next step for exebacase after the Phase 2 study?

Exebacase is currently being evaluated in a Phase 3 DISRUPT study aimed at validating its effectiveness in treating Staphylococcus aureus bacteremia.

What is the significance of exebacase in treating MRSA?

Exebacase has shown potential as a first-in-class treatment for MRSA bacteremia, providing important improvements in clinical outcomes and mortality rates.