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    Home > Active Ingredient News > Immunology News > Clostridium difficile infection (CDI) new first-line treatment gold standard! New antimicrobial mGB-BP-3 cure rate of 100%, recurrence rate of 0!

    Clostridium difficile infection (CDI) new first-line treatment gold standard! New antimicrobial mGB-BP-3 cure rate of 100%, recurrence rate of 0!

    • Last Update: 2020-05-28
    • Source: Internet
    • Author: User
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    Dyscostic infection (CDI, photo: medscape.com)May 24, 2020 /
    Biovalley
    BIOON/-- MGB Biopharma is a biopharmaceutical company focused on developing new anti-infective drugsRecently, the company announced that the evaluation of the new antimicrobial drug MGB-BP-3 first-line treatment of Clostridium difficile infection (CDI) Phase II study has reached the end of safety, efficacy, dose selectionStudies confirm that MGB-BP-3, as a new antimicrobial drug, has the potential to become a new gold standard in the first-line treatment of CDIMGB-BP-3 is an antibacterial agent with antibacterial activity against a variety of important multi-drug-resistant and sensitive Gram-positive pathogensThe company is developing an MGB-BP-3 oral preparation for the treatment of CDIphase II dose range study was conducted in the United States and Canada and evaluated three dose levels for treatment of CDI patientsAs mentioned earlier, the drug showed better-than-expected efficacy at its lowest dose level (125 mg, 2 times per day), and this trend was further improved, with the maximum efficacy at the second dose level (250 mg, 2 times per day)data show thattake 250 mg of MGB-BP-3 2 times a day, 10 days in a row, 100% of the initial cure, 100% continuous curethe administration of the drug has now been identified forin Phase IIIclinical trialsto develop new drugs for the treatment of CDI, the most important goal is to prevent recurrent diseases and provide sustainable curesMGB-BP-3 achieves this through its unique fast-acting activity, a feature not available in other treatments At 250 mg dose, 2 times a day, 10 consecutive days of administration, MGB-BP-3 was measured 4 weeks after completion of treatment, and no recurrence of the disease was recorded In current antiseptic treatment, the recurrence rate is unacceptably high, with up to one-third of patients receiving the current mainstream treatment plan experiencing a recurrence of the disease consistent with the Phase I study, MGB-BP-3 showed good safety and tolerance, and neither the Phase I and Phase II studies reported severe adverse events (SAEs) "C C difficile infection is a major burden on the Canadian and U.S health care systems," said Lead researcher Dr Thomas Louie, lead investigator of the Phase II study and a clinical professor at the Cumming School of Medicine at the University of Alberta in Canada A new antibiotic to kill this deadly pathogen before it produces spores, giving hope to those suffering from the disease and their families "
    MGB-BP-3 (Photo: medchemexpress.com) Clostridium difficile infection (CDI) is a severe and often life-threatening ego infection that is the most common cause of diarrhea in hospitals and nursing homes In the United States alone, nearly 500,000 cases and about 30,000 deaths each year are related to CDI; CDI has been identified by the U.S Centers for Disease Control and Prevention (CDC) as an emergency threatening pathogen, a common consequence of antibiotic treatment in hospitalized patients MGB-BP-3 has been acquired by the U.S Food and Drug Administration (
    the FDA ) grants qualified infectious disease products (QIDP) accreditation, can be submitted quickly, and has a long-term exclusive sales rights for 5 years MGB-BP-3 will also be eligible to participate in the DISARM deprescription incentive program being considered in the United States, which will increase patients' access to new and innovative treatments MGB-BP-3 has a very fast bactericidal effect, can kill its nutrients before clostridium difficile forms spores, thus achieving initial cure and preventing the recurrence of the disease by reducing the total load of Clostridium difficile in addition, , MGB-BP-3 has strong bactericidal activity on BI/NAP1/027 strains, while BI/NAP1/027 strains are currently the most resistant CDI (photo source: thegastroenterologist.ro) speed of action is a key success factor in the treatment of CDI, as Clostridium difficile can be present in both the form of disease-causing nutrients and sleep spores Fully developed spores, which are resistant to any antimicrobial treatment, are formed in harsh environments that are usually treatment with antibiotics During spore production, bacteria to maintain a sensitivity period of at least 10 hours to the of antibiotics, which provides a period of time for rapid sterilization antibiotics such as MGB-BP-3 to kill bacteria the current treatment of CDI mainstream drugs vancomycin (vancomycin) and non-damycin (fidaxomicin) are antiseptics, it takes more than 24 hours to achieve maximum results These characteristics mean that in many patients, these antibiotics trigger spore formation, which leads to a high recurrence rate when the spores germinate nutrients Dr Miroslav Ravic, ceo of MGB Biopharma, said: "We are pleased to have successfully reached our destination in the Phase II trial, which is an important milestone for our company The study identified a dose that provided a good balance between maximizing the killing of dyslenococcal Clostridium difficile and the minimal impact on the remaining normal intestinal flora This leads to a high initial cure rate and a recurrence of the disease " Dr Miroslav Ravic added: "As the recent COVID-19 pandemic shows, the world urgently needs new anti-infection therapies so that we can better respond to new threats MGB-BP-3 will bring a new and significantly improved paradigm to CDI treatment, which will reduce morbidity and mortality from this terrible infection (BioValleyBioon.com) original origin: MGB Biopharma Announces SelectS Successful From Phase Ii Clinical Study with MGB-BP-3 - a Potential New Gold Standard, First-Line For Clostridium difficile (Infection CDI)
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