YONKERS, NY, October 26, 2020 (GLOBE NEWSWIRE) – ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company targeting the discovery and progression of direct lytic agents (DLA), adding lysines and amurin peptides, such as New Medical Modality for the Remedy of Life Threatening Antibiotic Resistant Infections, announced today that it has introduced an expanded access program to provide exbacas for the remedy of persistent bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA) in patients with COVID-19. Exebacase received Advanced Therapy designation for the remediation of MRSA blood infections through the United States Food and Drug Administration (FDA). The company offers expanded access to exbacase as a component of a remedial protocol for clinical centers participating in the ongoing phase 3 study, allowing clinicians to use exbacase to treat critically ill COVID-19 patients with persistent bacteremia. by MRSA despite popular attention antibiotic remedy. Array These COVID-19 inpatients can now have access to exbacase as they are not eligible to take the component in the ongoing phase 3 study. Based on the effects of the completed phase 2 study, the company believes that the exbacase remedy in addition to antistaphylococcal antibiotics has the potential to improve the final clinical outcomes of many COVID-19 patients who have persistent MRSA bacteremia. More information about the program can be found at www. clinicaltrials. gov (NCT04597242).
Roger J. Pomerantz, MD, FACP, President, CEO and President of ContraFect said: “As a company committed to combating serious infectious diseases, it is our duty to actively seek to help critically ill patients with COVID-19. . Exebacase has the possibility of treating MRSA overinfections in patients inflamed with COVID-19, a leading cause of serious disease. This persistent crisis, in addition to the next flu season, requires that our prospective revolutionary treatment be applied to all patients with life-threatening MRSA bacteremia, and we hope that exebacase can have a positive effect on patient outcomes.
Respiratory viral infections, such as influenza, SARS, and MERS, are sometimes linked to secondary infections or overinfections through opportunistic pathogens. result of secondary bacterial pneumonia. 1,2 Although knowledge is lately limited, secondary bacterial infections such as the COVID-19 pandemic were observed in China, with up to 50% of patients died with secondary infection3,4. This prospective role of bacterial overinfections in the results of COVID-19 patients have recently been identified as an emerging challenge in the United States. Staph aureus is one of the most common pathogens of secondary bacterial infections in patients with severe respiratory viral infections.
This is another compassionate use program for exebacase. ContraFect continues to provide early access to exebacase to individual patients named with chronic postoperative prosthetic infections (PYIs) as a component of the National Agency for the Safety of Medicines and Health Products’ transitional use authorizations downloaded through Dr. Tristan Ferry at Croix Rousse Hospital in Lyon, Francia. La PJI plant poses significant remedy disorders due to biofilm formation , which disables traditional antibiotics and requires surgical removal and replacement of the prosthetic joint. treatments for PJI remedy and surgery (e. g. removal and replacement of the inflamed joint) is the existing popular care. Through this compassionate use program, ContraFect can download an early evaluation of the protection of intraarticular exebacase management and prospective early symptoms of the efficacy of exebacase as a prospective healing agent for PYI.
About Exebacase (CF-301):
Exbacase is a recombinantly produced lysine (mobile wall hydrolase enzyme) with potent bactericidal activity opposed to Staph aureus, a leading cause of blood infections (BSI) also known as bacteremia. In the exbacase company Phase 2 examination, a pre-specified investigation of patients inflamed with MRSA showed that the clinical reaction rate on day 14 in exbacase treated patients is approximately 43 endpoints. percentage higher than that of patients treated with popular care. (SOC) alone (74. 1% for patients treated with exbacase compared to 31. 3% for patients treated with SOC antibiotics only (p = 0. 010)). In addition to the superior clinical reaction rate, exbacase-treated MRSA-inflamed patients showed a 21 percentage point relief in all-cause mortality at 30 days (P = 0. 056), a decrease in mean hospital stay. 4 days and significant relief in hospital readmission rates. Exbacase is recently being investigated in the phase 3 design of the Staph aureus-resistant pathogen direct lysis trial (DISRUPT) examining exbacase in patients with Staph aureus bacteremia, adding endocarditis. On the right side.
Exebacase has the prospect of being a first-rate remedy for Staph aureus bacteremia. Exebacase is licensed by Rockefeller University and is progressing in ContraFect.
About DISRUPT:
The Phase 3 DISRUPT exebacasas test is a randomized, double-blind, placebo-controlled clinical trial conducted in the United States to compare the efficacy and protection of exebacasa in approximately 350 patients with Staph aureus-complicated bacteremia, adding right endocarditis. Phase 3 studies are randomized 2:1 to obtain exebacase or placebo, all patients receiving SOC antibiotics. The study’s number one efficacy endpoint is the clinical reaction on day 14 in patients with MRSA bacteremia, adding right endocarditis. 14 clinical reaction in all patients with Staph aureus (MEMS and Staph methiciline sensitive aureus (MSSA), all-cause mortality at 30 days in patients with MRSA and clinical reaction at later times. The company plans to conduct an interim futility investigation after registering approximately 60% of the population examined.
About ContraFect:
ContraFect is a biotechnology company focused on the discovery and progression of direct lytic agents (ADLs), adding lysines and amurin peptides, as novel medical modalities for the remedy of resistant and life-threatening infections. antibiotics An estimated 700,000 international deaths each year are attributed to antimicrobial resistant infections. We intend to fight potentially fatal infections by employing our applicants for healing products from our DLA platform, which come with lysines and amurin peptides. Lysines are a new elegance of DLA that are antimicrobial proteins produced by recombination with a new mechanism of action related to the immediate destruction of the target bacteria, the eradication of biofilms and the synergy with traditional antibiotics. Amurin peptides are a new DLA elegance exhibiting broad spectrum activity against a wide variety of antibiotic resistant gram-negative pathogens, adding species of Pseudomonas aeruginosa (P. aeruginosa), Acinetobacter baumannii and Enterobacter. We believe that the homes of our lysines 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 bacteraemia, pneumonia, and osteomyelitis. We have completed a phase 2 clinical trial for the remedy for Staph aureus bacteremia, adding endocarditis, with our flagship lysine candidate, exbacase, which is the first lysine to enter clinical trials in the United States. clinical phase 3 study, has achieved the designation of Advanced Therapy through the FDA for the remedy of circulatory infections by MRSA of the blood, adding right endocarditis, when used in addition to antistaphylococcal antibiotics SOC in adult patients.
Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.
Forward-looking statements
This press release contains, and our officials and representatives may from time to time make, “forward-looking statements” within the meaning of US federal securities laws. Forward-looking statements would possibly be known through words such as “plans. ” , “possibly”, “will”, “may also”, “could”, “should”, “believe”, “plans”, “anticipates”, “estimates”, “anticipated”, “anticipated”, “prospective”, “promises” or similar references to long-term periods. Examples of forward-looking statements in this release include, but are not limited to, statements regarding: ContraFect’s ability to notice and expand DLA as novel medical modalities for the remediation of life-threatening antibiotic resistant infections, if the Company will release the expanded access program and expanded access provision to exbacase for COVID-19 patients, whether doctors will use exbacase to treat COVID-19 patients, whether COVID-19 hospital patients will have access to exbacase, whether the exbacase remedy in addition of antistaphylococcal antibiotics has the prospect of improving the final clinical outcomes of many COVID-19 patients who have persistent MRSA bacteremia, statements through Dr. Pomerantz, statements related to secondary infections and their cited references, if Staph aureus is one of the main non-unusual pathogenetic reasons for secondary bacterial infections in patients with severe respiratory viral infections, if the company continues to provide early access to exbacase for separately designated patients with PJI in ATU, if ContraFect will download an early protection assessment of intravenous administration. articular exbacase and early symptoms of exbacase’s efficacy as a curative agent, if exbacase has the prospect of being a first-order remedy for exbacase, if ContraFect will treat life-threatening infections using its DLA platform, if lysines are a new elegance of DLA, which are antimicrobial proteins produced by recombination with a new mechanism of action related to the immediate destruction of the target bacteria, the eradication of biofilms and the synergy with traditional antibiotics, if amurins are a new elegance of DLA exhibiting a broad spectrum activity versus wide diversity. of gram-negative pathogens if they are resistant to antibiotics and if ContraFect’s lysines and amurins homes are suitable for attacking antibiotic resistant organisms such as MRSA and P. aeruginosa. Forward-looking statements are statements that are not old facts or guarantees of long-term performance. Instead, they are based on ContraFect’s existing beliefs, expectations, and assumptions about the long-term of your business, your plans, strategies, projections, expected times and trends, the economy, and other long-term conditions. Because forward-looking statements relate to the long term, they are subject to inherent risks, uncertainties and adjustments in cases that are difficult to expect and many of which are beyond ContraFect’s control, adding those detailed under the heading “ Risk factors ”In documents filed through ContraFect with the Securities and Exchange Commission. Actual effects may differ from those presented in the forward-looking statements. Important points that can also cause real effects on diversity include, but are not limited to, our ability to expand remedies for drug-resistant infectious diseases. Any forward-looking statements made through ContraFect in this press release are based solely on existing information and refer only to the date it was made. Except as required by applicable law, ContraFect expressly disclaims any legal responsibility to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new data, long-term extensions or others .
References:
David M. Morens, Jeffery K. Taubenberger and Anthony S. Fauci (2008). Predominant role of bacterial pneumonia as a cause of death in pandemic influenza: implications for preparing for pandemic influenza. Journal of Infectious Diseases 198 (7): 962-970.
Denise E. Morris, David W. Cleary and Stuart C. Clarke (2017). Secondary bacterial infections with influenza pandemics Borders in microbiology, June 2017, volume 8, article 1041.
Fei Zhou, Ting Yu, Ronghui Du y col. (2020). Clinical evolution and mortality points for adult patients hospitalized with COVID-19 in Wuhan, China: a retrospective cohort study The Lancet, published online on March 9, 2020 https://doi. org/10. 1016/S0140-6736(20)30566-3.
Xiaobo Yang, Yuan Yu, Jiqian Xu et al (2020). Clinical evolution and outcomes of critical patients with SARS-CoV-2 pneumonia in Wuhan, China: a retrospective observational study from a single center The Lancet Published online on February 21, 2020 https://doi. org/10. 1016/S2213-2600 ( 20) 30079-5.
Kenneth Thorpe (2020). Industry Voices – Another enemy emerges in COVID-19 combat: antibiotic-resistant insects. Fierce Healthcare https://www. fiercehealthcare. com/hospitals-health-systems/industry-voices-another-enemy-emerges-covid-19 -resistant to combat antibiotics
Dr. Julie Gerberding (2020). Antibiotic resistance: Covid-19. STAT hidden risk https://www. statnews. com/2020/03/23/antibiotic-resistance-hidden-risk-lurking–covid-19/
Investor relations contacts
Michael Messinger ContraFect Corporation mmessinger@contrafect. com
Carlo Tanzi, Dr. Kendall with investisseursctanzi@kendallinvestor. com