ContraFect’s New Phase 2 Exebacase Data Presented at IDWeekTM Demonstrates Rapid Symptom Resolution Among Patients with Staphylococcus aureus Bacteremia

Rhea-AI Summary

ContraFect Corporation (Nasdaq:CFRX) announced promising Phase 2 results of exebacase for treating Staphylococcus aureus bacteremia, presented at IDWeek 2021. The data indicates that 94.3% of patients receiving exebacase alongside standard antibiotics experienced symptom resolution, compared to 87.9% in the control group. Median time to resolution was significantly reduced to 3 days from 6 days. Exebacase may serve as a new treatment modality for serious bloodstream infections, including MRSA, where current options are limited. The company is advancing to a pivotal Phase 3 trial for further evaluation.

Positive

• Exebacase demonstrated 94.3% symptom resolution in bacteremia patients when added to standard care.
• Median time to symptom resolution decreased to 3 days in exebacase-treated patients compared to 6 days for standard care alone.
• Exebacase shows potential as a first-in-class treatment for Staphylococcus aureus bacteremia.
• The company is progressing to Phase 3 DISRUPT study, indicating continued development of exebacase.

Negative

• None.

YONKERS, New York, Oct. 04, 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 new data from the Company’s Phase 2 study of exebacase demonstrating rapid symptom resolution among patients with Staphylococcus aureus (Staph aureus) bacteremia. These data were recently presented as a Late Breaker oral presentation at IDWeek™ 2021, that was held from September 29 through October 3, in San Diego, CA.

“The important, new data presented at IDWeek is further detailed validation of the potential utility of exebacase in such pernicious infections, and it clearly demonstrates rapid and meaningful symptom resolution when exebacase is added to standard of care antibiotics. This is especially important as the options for treating serious bloodstream infections, such as those caused by MRSA, continue to be few, with exebacase being one of the few new modalities being developed for these types of infections,” stated Cara Cassino, M.D., ContraFect’s Chief Medical Officer and Executive Vice President of Research & Development.

Staph aureus is a leading cause of infections in US healthcare facilities. Any Staph infection can be deadly. Staph aureus infections can be either methicillin-resistant (MRSA) or methicillin-susceptible (MSSA). MRSA infections are particularly difficult to treat because of their resistance to antibiotics, increasing virulence and patient comorbidities.

The oral data presentation, Exebacase Shows Rapid Symptom Resolution in a Phase 2 Study in Adult Patients with Staphylococcus aureus Bacteremia, demonstrated that exebacase, used in addition to standard of care antibiotics (SOCA), more rapidly resolved symptoms of Staph aureus bacteremia versus SOCA alone.

Specifically, the data show:

• 86 patients with Staph aureus bacteremia, including endocarditis, had at least one symptom present at baseline (53 patients in the exebacase+SOCA group and 33 SOCA-alone patients). Symptoms resolved in the majority of these patients (94.3% in the exebacase-treated group versus 87.9% of SOCA-alone patients).
  
  
• The median time to resolution was 3 days for exebacase-treated patients compared to 6 days for SOCA-alone patients.

• MRSA: The median time to symptom resolution in patients with MRSA bacteremia was 3 days in exebacase-treated patients, as compared to 7 days in patients who received SOCA alone.
  
  Among the exebacase-treated patients with MRSA bacteremia, 94.1% showed symptom resolution compared with 81.8% of SOCA-alone patients.
  

• MSSA: The median time to symptom resolution in patients with MSSA bacteremia was 3 days in exebacase-treated patients, as compared to 6 days in patients who received SOCA alone.
  

Time to resolution of symptoms was analyzed using Kaplan-Meier methods. For those symptoms (shortness of breath, sweating, fatigue and/or confusion) present at baseline and attributable to the bacteremia, time to resolution of symptoms was defined as the number of days until all attributable symptoms were absent.

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 was well-tolerated and treatment emergent adverse events, including serious treatment-emergent serious adverse events (SAEs) were balanced between the treatment groups. There were no SAEs determined to be related to exebacase, there were no reports of hypersensitivity related to exebacase and no patients discontinued treatment with study drug in either treatment group.

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. The lysin 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, including its clinical utility and symptom resolution, 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 (CFRX)?

Exebacase showed 94.3% symptom resolution in patients with Staphylococcus aureus bacteremia, with a median time to resolution of 3 days compared to 6 days for standard care.

What is the significance of the data for exebacase in treating Staphylococcus aureus infections?

The data suggests that exebacase could provide a new treatment option for serious bloodstream infections, particularly as existing treatments for MRSA are limited.

What are the next steps for ContraFect (CFRX) following the Phase 2 study of exebacase?

ContraFect is moving forward with a pivotal Phase 3 study named DISRUPT to further assess the efficacy of exebacase in treating Staphylococcus aureus bacteremia.

What does exebacase's performance indicate for its market potential?

The favorable results from the Phase 2 study indicate strong market potential for exebacase as a first-in-class treatment for antibiotic-resistant infections.