12 September 2016: Glasgow, UK – MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announces today that the US Food and Drug Administration (FDA) has granted MGB-BP-3, MGB Biopharma’s lead product, Qualified Infectious Disease Product (QIDP) designation for the Treatment of Clostridium difficile-associated Diarrhoea (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.
Dr Miroslav Ravic, CEO of MGB Biopharma, said: “We are very pleased with the FDA's decision to grant QIDP designation to MGB-BP-3 as we believe this drug has the potential to provide a significant benefit in the treatment of Clostridium difficile-associated Diarrhoea (CDAD). Granting of the QIDP designation highlights the potential of MGB-BP-3 to address serious and life-threatening infections and is an important milestone in the development of our lead product, as we prepare to initiate the Phase II clinical trial.”
Dr Ravic, added: “Around the world, governments and global organisations are calling for new anti-bacterial drugs and are introducing incentives to reward companies for delivering these products; only last week antimicrobial resistance (AMR) was on the agenda of the G20 Summit. Our MGB-based anti-infectives have the potential to deliver significant advantages over current approaches.”
While pursuing its clinical development activities, MGB Biopharma is now evaluating partnering and funding sources for its lead compound MGB-BP-3, which has the potential to offer a clear differentiated treatment option for patients with life threatening infections caused by resistant and susceptible Clostridium difficile strains.