MGB's research new drug application for MGB-BP-3, lead candidate drug, approved by FDA and Health Canada
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, MGB Biopharma Biopharma Bio
Pharmaceutical(http://company(http://announced that the U.SFood andDrug(http://Administration (
FDA(http://) and Health Canada has approved its lead drug MGB-BP-3 researchnew drug (http:// IND/CTA)application (IND/CTA)the company plans to launch Phase IIa clinical studies of MGB-BP-3 in the United States and Canada in the first quarter of 2019 to treat CDADThe study will assess the initial cure and ongoing cure rate of MGB-BP-3 in CDAD therapy, and the overall results of the study are expected to be published in the third quarter of 2019 about MGB-BP-3
MGB-BP-3 has strong bactericidal activity and fast sterilization, and the drug is the only drug that kills Clostridium difficile within 10 hours of exposure This new MGB-BP-3 treatment model makes it a first-line treatment for CDAD MGB-BP-3 is a powerful bactericidal antibiotic with a new mode of action, which is active for a variety of important multidrug resistance and susceptible gram-positive bacteria The MGB-BP-3 oral preparation was developed specifically for the treatment of CDAD, the most common type of infection in hospitals in developed countries, with a high mortality rate of 1 in 11 cases of patients aged 65 or over within 30 days of diagnosis MGB believes that MGB-BP-3 has the potential to provide a new model for CDAD treatment, as it kills Clostridium difficile in a nutritional state quickly before citaco spores form Therefore, compared to the number of sleepcilled Clostridium disspores formed during treatment with other antiseptic antibiotics, the number of dormant clostridium disphony spores formed during treatment with MGB-BP-3 decreased, thereby significantly reducing disease recurrence MGB-BP-3 also has a strong bactericidal effect on the highly pathogenic strain BI/NAP1/027 (except other test (http:// strain), which has a weak reaction to current antimicrobial treatment
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