The Food and Drug Administration (FDA) and Health Canada have cleared Investigational New Drug applications (IND) for MGB Biopharma’s lead candidate MGB-BP-3, used for the treatment of clostridium difficile-associated diarrhoea (CDAD).

MGB-BP-3 has the potential to offer a new paradigm in the treatment of CDAD because it kills clostridium difficile, which causes almost half a million infections among patients in the US in a single year, whilst still in its vegetative form, before it sporulates.

The treatment is a potent bactericidal antibiotic with a completely novel mode of action that is active against a broad range of important multi-resistant and susceptible gram-positive pathogens.

A Phase IIa trial to evaluate MGB-BP-3 in patients with CDAD is on track to start in the first quarter of 2019.

Dr Thomas Louie, a clinical professor at the Cumming School of Medicine at the University of Alberta, Calgary and the trial’s Principal Investigator commented: “C. difficile infection represents a major burden to the Canadian and US healthcare systems. A novel antibiotic that is able to kill this deadly pathogen before it is able to sporulate offers new hope to patients and their families who suffer the pain and misery caused by this disease.”

The oral formulation of MGB-BP-3 is being developed specifically for the treatment of CDAD, an infection to which the most frequent occurrence of diarrhoea in hospitals in developed countries is attributed. These infections have a high mortality rate, with 1 out of every 11 patients aged 65 or older dying within 30 days of diagnosis.