The Food and Drug Administration (FDA) has granted MGB-BP-3 (MGB Biopharma) Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated diarrhea (CDAD).

MGB-BP-3 was found to be well tolerated, with no systemic absorption and no effect on intestinal permeability, in a Phase 1 trial of healthy volunteers. The company is currently preparing to initiate a Phase 2 study to evaluate the efficacy and safety of MGB-BP-3 in patients with CDAD caused by the strain B1/NAP1/027, the most virulent C. difficile ribotype with the highest morbidity and mortality in CDI patients. 

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MGB-BP-3 is an antibacterial with activity against a broad range of multi-resistant and susceptible Gram-positive pathogens. Its oral formulation is under development for the treatment of CDAD while the intravenous formulation is intended to target a range of systemic hospital acquired Gram-positive infections. A topical formulation is also under investigation for the treatment of serious skin infections.

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