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    Home > Active Ingredient News > Immunology News > MRAS bacteremia treatment in the past 60 years significant progress! The US FDA awarded the breakthrough drug qualification of the new antibacterial drug exebacase!

    MRAS bacteremia treatment in the past 60 years significant progress! The US FDA awarded the breakthrough drug qualification of the new antibacterial drug exebacase!

    • Last Update: 2020-02-26
    • Source: Internet
    • Author: User
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    February 26, 2020 / BIOON / -- contract is a clinical stage biotechnology company, which is committed to the discovery and development of new antibiotics to treat life-threatening antibiotic resistant infections

    Recently, the company announced that the U.S

    Food and Drug Administration (FDA) has awarded the breakthrough drug qualification (BTD) of recombinant cell wall lysin exebacase (cf-301), combined with standard care (SOC) anti staphylococcal antibiotics, for the treatment of methicillin-resistant Staphylococcus aureus (MRAS) bacteremia in adult patients, including right endocarditis

    This is a very difficult infection to treat, although the use of traditional antibiotics, but the effect has been very poor

    In clinical research, exebacase combined with SOC antibiotic treatment significantly improved the clinical success rate and reduced the mortality compared with SOC antibiotic treatment

    Mechanism, clinical trial and development prospect of exebacase

    For details, click corporate presentation

    BTD is a new drug review channel established by FDA in 2012

    It aims to accelerate the development and review of new drugs for the treatment of serious or life threatening diseases, and there is preliminary clinical evidence that the drug can substantially improve the condition compared with existing treatment drugs

    The drugs that obtain BTD can receive more close guidance, including FDA senior officials, during the research and development, so as to guarantee to provide patients with new treatment options in the shortest time

    The FDA awarded exebacase BTD based on the final data of the phase II superiority trial in patients with Staphylococcus aureus bacteremia, including endocarditis

    The trial evaluated whether the addition of exebacase to the treatment of SOC antibiotics could improve the clinical efficacy compared with the use of SOC antibiotics alone

    The results showed that on the 14th day, the clinical response rate of patients treated with exebacase was 42.8% (74.1% vs 31.3%, P = 0.010) higher than that of patients treated with SOC alone

    In addition, exebacase treatment also reduced the 30 day all-cause mortality by 21% (P = 0.056), hospital stay by 4 days, and the 30 day readmission rate of patients with MRSA infection was significantly reduced

    "Since the first approval of vancomycin in 1958, only one additional drug (daptomycin, approved in 2006) has been approved by FDA in the treatment of MRSA bacteremia, which is based on the relative non inferiority of vancomycin," said Roger J

    Pomerantz, MD, President, CEO and chairman of contract

    Despite the new drug, MRSA bacteremia, a neglected infectious disease, has not improved in clinical treatment failure and mortality for more than 60 years

    The FDA's decision to qualify exebacase as a breakthrough drug recognizes the urgent need for innovative therapies that affect patients with MRSA infection

    Based on phase II clinical data, we believe that exebacase may be the first anti infective drug that has been proven to be more effective in these patients

    " Exebacase is a recombinant lysin (lysin, cell wall hydrolase), which is only 26 KD in size

    It has strong bactericidal activity against Staphylococcus aureus

    Lysin is a direct lysate derived from bacteriophage, which is an efficient bacterial killer in nature

    Lysin has a new mechanism of action, targeting the cell wall of bacteria, leading to the direct death of bacteria

    Staphylococcus aureus is the main cause of blood stream infection (BSI), also known as bacteremia

    Exebacase is expected to be a first-in-class drug for the treatment of Staphylococcus aureus bacteremia

    It has a novel, rapid and specific mechanism of action, targeting the peptidoglycan cell wall, which is essential for Staphylococcus aureus

    In addition, in vitro and in vivo experiments show that exebacase has a very high activity for the biofilm that complicates the infection of Staphylococcus aureus

    Exebacase is licensed from Rockefeller University and is currently being developed by contractact

    At present, the company is carrying out a key randomized double-blind placebo-controlled phase III clinical study (disrupt) to confirm the results obtained in phase II clinical trials

    Based on the interaction with FDA on the optimization of exebacase development, in addition to the complete data package generated so far, this single phase III study can be used as the basis for FDA to review and approve the application for permission of exebacase biological products (BLA)

    (bio

    Com) original source: contract announcements U.S

    FDA grants break through therapy design to exit for the treatment of methicillin resistant Staphylococus aureus (MRSA) bacteremia, including right sided endocarditis
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