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CST: 16/10/2019 18:56:34   

ContraFect Presents Additional Positive Data from the Phase 2 Trial of Exebacase at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

183 Days ago

New data include secondary endpoint analyses of clinical responder rates at Day 7, End of Treatment, and Test of Cure, and pre-specified analyses of the clinical responder rates by final diagnosis at Day 14

New MRSA data shows that the increased response previously reported at Day 14 persists at all timepoints; MRSA patients treated with exebacase demonstrated an early and durable increase in clinical responder rates through Test of Cure compared to patients treated with standard of care alone

YONKERS, N.Y., April 16, 2019 (GLOBE NEWSWIRE) --  ContraFect Corporation (Nasdaq:CFRX), a clinical-stage biotechnology company focused on the discovery and development of biologic therapies for life-threatening, drug-resistant infectious diseases, today announced that new data from its Phase 2 clinical trial of exebacase for the treatment of Staphylococcus aureus (Staph aureus) bacteremia including endocarditis was presented by Vance G. Fowler, M.D., Professor of Medicine in the Division of Infectious Diseases, Duke University at a late-breaker session at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The oral presentation, titled “Exebacase (Lysin CF-301) Improved Clinical Responder Rates In Methicillin Resistant Staphylococcus Aureus (MRSA) Bacteremia Including Endocarditis Compared To Standard Of Care Antibiotics Alone In A First-in-Patient Phase 2 study,” reported new data demonstrating clinically meaningful increases in clinical responder rates in the pre-specified MRSA subgroup treated with exebacase, including a 22.9% higher responder rate at Day 7 and a 16.9% higher responder rate at Test of Cure, compared to MRSA patients treated with standard of care antibiotics (SOC) alone. Pre-specified analyses of data from the overall population also showed that patients with complicated bacteremia had a 20.3% higher clinical responder rate with exebacase compared to those who received SOC alone (78.6% and 58.3% for the exebacase + SOC and SOC alone groups, respectively).

“We are excited by the impressive results observed in the pre-specified MRSA subgroup treated with exebacase. MRSA bloodstream infections remain an area of extremely high unmet medical need with few treatment options, and our Phase 2 superiority design study demonstrated a clinical responder rate of 74.1% at Day 14 in the MRSA subpopulation, which represents a 42.8% improvement over standard of care antibiotics alone,” said Dr. Roger J. Pomerantz, President and Chief Executive Officer, and Chairman of ContraFect. “We are also pleased to see the 20.3% higher clinical responder rate at Day 14 among all complicated bacteremia patients treated with exebacase compared to those treated with SOC alone, further validating our belief that exebacase may play a critical role in the treatment of complicated bacteremia, as well as resistant infections such as MRSA.”

Clinical Responder Rates of Pre-specified MRSA Subgroup:

  Day 7 Day 14 End of Treatment Test of Cure
 
Number of Patients
Exebacase
+ SOC
SOC
alone
Exebacase
+ SOC
SOC
alone
Exebacase
+ SOC
SOC
alone
Exebacase
+ SOC
SOC
alone
 

Responders/Total
(Response %)

 
 

18/27
(66.7%)
 

7/16
(43.8%)
 

20/27
(74.1%)
 

5/16
(31.3%)
 

14/27
(51.9%)
 

7/16
(43.8%)
 

13/27
(48.2%)
 

5/16
(31.3%)

Cara Cassino, M.D., Chief Medical Officer and Executive Vice President of Research and Development at ContraFect, said, “We are very encouraged by these results which strongly suggest the potential for exebacase to offer substantial clinical benefit to patients with MRSA bloodstream infections, and we look forward to advancing exebacase into a definitive Phase 3 trial.” 

The Phase 2 clinical trial of exebacase is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial in patients with Staphaureus bacteremia including endocarditis. This superiority design study compared the responder rates with exebacase administered on a background of antibiotic therapy to antibiotics alone. The primary efficacy endpoint in this study was the clinical responder rate at Day 14 in patients with Staph aureus who received study drug. Clinical responder rates at Day 7, End of Treatment (EOT) and Test of Cure (TOC) were evaluated in the same population as secondary efficacy endpoints. The clinical responder rates at Day 7, Day 14, EOT and TOC were 71.8%, 70.4%, 62.0% and 54.9%, respectively, for patients treated with exebacase compared to 68.9%, 60.0%, 62.2% and 55.6%, respectively for patients treated SOC alone.

The detailed presentation can be accessed on the News/Events page of the ContraFect website.

About ContraFect:

ContraFect is a biotechnology company focused on discovering and developing differentiated biologic therapies for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. 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 lysin platform and through the use of other novel agents. Lysins are a new therapeutic class of bacteriophage-derived, 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. We believe that the properties of our lysins will make them suitable for targeting antibiotic-resistant organisms, such as Staph aureus and Pseudomonas aeruginosa (P. aeruginosa), which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. Our lead lysin candidate, exebacase is completing a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis and is the first lysin to enter clinical studies in the U.S.

Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.

About Exebacase (CF-301):

Exebacase (CF-301) is a recombinantly-produced lysin (cell wall hydrolase enzyme) with potent bactericidal activity against Staph aureus, a major cause of blood stream infections (BSIs) also known as bacteremia. Exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia.  It has a novel, rapid, and specific mechanism of bactericidal action against Staph aureus. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to exebacase. In addition, in vitro and in vivo experiments have shown that exebacase is highly active against biofilms which complicate Staph aureus infections. Exebacase was licensed from The Rockefeller University and is being developed at ContraFect.

F orward-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 whether the additional data from the Phase 2 trial to be presented at ECCMID is positive, whether the data, which includes secondary endpoint analyses of clinical responder rates at Day 7, End of Treatment, and Test of Cure, and pre-specified analyses of the clinical responder rates by final diagnosis at Day 14 are considered new, whether the MRSA data that showed increased response previously reported at Day 14 persists at all timepoints, whether MRSA patients treated with exebacase demonstrated an early and durable increase in clinical responder rates through Test of Cure compared to patients treated with SOC alone, the Company’s ability to discover and develop biological therapies for life-threatening, drug-resistant infectious diseases, whether presented data from the Phase 2 study of exebacase is new, whether the data demonstrated clinically meaningful increases in clinical responder rates in the pre-specified MRSA subgroup treated with exebacase compared to MRSA patients treated with SOC alone, whether the pre-specified analyses of data from the overall population showed that patients with complicated bacteremia had a higher clinical responder rate with exebacase compared to those who received SOC alone, whether exebacase may play a critical role in the treatment of complicated bacteremia and resistant infections such as MRSA, whether the results strongly suggest the potential for exebacase to offer substantial clinical benefit to patients with MRSA bloodstream infections, whether the Company will advance exebacase into a definitive Phase 3 trial, statements made which include responder rates, the Company’s ability to address life threatening infections using its therapeutic product candidates from its lysin platform and through the use of other novel agents, whether lysins are a new therapeutic class of bacteriophage-derived, 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 the properties of the Company’s lysins will make them suitable for targeting antibiotic-resistant organisms, such as Staph aureus and P. aeruginosa, whether exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia, whether resistance is less likely to develop to exebacase, whether exebacase is highly active against biofilms which complicate Staph aureus infections and the accuracy of all responder rate percentages. 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 those detailed 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
Email: mmessinger@contrafect.com

Lauren Stival
Stern Investor Relations
Tel: 212-362-1200
Email: lauren.stival@sternir.com

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