MGB Biopharma gains QIPD designation in Clostridium difficile-associated diarrhea for MGB-BP-3

Scotland-based MGB Biopharma announced today that the US Food and Drug Administration has granted MGB-BP-3, the firm’s lead product, Qualified Infectious Disease Product (QIDP) designation for the Treatment of Clostridium difficile-associated diarrhea (CDAD). The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by “qualified pathogens”.

MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a gram-positive bacterium responsible for the majority of cases of infectious hospital-acquired diarrhoea in developed countries.

Successful completion of the clinical Phase I study of MGB-BP-3 confirmed the compound was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora. MGB is preparing to initiate the Phase II clinical study for MGB-BP-3 and investigate the safety and efficacy in patients with CDAD, caused by the most virulent ribotype of C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy.