ContraFect Announces Award from the Cystic Fibrosis Foundation to Evaluate Exebacase as a Potential Treatment for Serious MRSA Lung Infections Associated with Cystic Fibrosis
YONKERS, N.Y., Jan. 06, 2022 (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, today announces that it has received an additional award from the Cystic Fibrosis Foundation (CFF). This contract award will support investigation of the potential utility of exebacase for treating serious lung infections caused by methicillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis (CF). The program, titled Nonclinical Assessment of Lysin Exebacase for Treating MRSA Infections in CF will, over the course of 12 months, evaluate the in vitro activity of exebacase against bacterial specimens obtained from CF patients.
“MRSA lung infections lead to potential acceleration in the decline in lung function and are an independent predictor of mortality in the CF population. Eradication of persistent MRSA in the lungs of CF patients remains a major challenge despite current antibiotic therapy. Thus, there is a pressing unmet need for new medical modalities and novel therapeutic approaches to address the serious health threat to CF patients,” said Cara Cassino, M.D., Executive Vice President of Research & Development and Chief Medical Officer of ContraFect. “We are pleased to have the opportunity to work with the CF Foundation again in order to evaluate the potential utility of exebacase as such a treatment for MRSA lung infections in this vulnerable population,” continued Dr. Cassino.
Pathogenic bacteria are known to be a major contributor to CF disease. The lungs of CF patients are typically colonized with pathogenic bacteria, that damage the epithelial surfaces. The growth of highly resistant Staph aureus or Pseudomonas aeruginosa, two of the most common causes of lung infections in CF patients, is associated with further epithelial surface damage, and potentially an overall decline in pulmonary function. MRSA has become more prevalent in the CF population in recent years, increasing from 9.2 percent in 2002 to 25.9 percent in 2017. MRSA plays a role in pulmonary exacerbations of CF that may require hospitalization and treatment with systemic antibiotics. Chronic lung infections are known to be the main cause of lung function deterioration, and ultimately mortality, in CF patients.
The award from the Cystic Fibrosis Foundation will provide ContraFect with financial support for research activities. Further financial details were not disclosed. ContraFect retains global rights for exebacase and its entire DLA therapeutic pipeline.
About Cystic Fibrosis
Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. People with CF are prone to infections of the lungs because they develop abnormally thick, sticky mucus which traps germs in their airways and therefore does not have the same infection-fighting properties as normal mucus. This abnormal mucus provides an ideal environment for bacteria to form protective layers -- known as biofilms -- that make them more difficult to kill. Many individuals also suffer severe side effects from long-term antibiotic use, such as hearing loss, and are at increased risk of lung function deterioration and ultimately mortality.
About Exebacase (CF-301):
Exebacase is an anti-staphylococcal 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. It is the first lysin to enter clinical studies in the U.S. and 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.
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. 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 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.
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.
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: the potential for exebacase to treat serious MRSA lung infections associated with CF, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, statements regarding the award, CF and CFF, statements made by Dr. Cassino, whether the award will provide ContraFect with financial support for research activities, whether exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia, ContraFect’s ability to 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.
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Released January 6, 2022