MGB Biopharma has announced an update on progress in its Phase IIa clinical study assessing the safety, tolerability and efficacy of incremental doses of MGB-BP-3 in patients with clostridium difficile-associated diarrhoea (CDAD).
The drug in question, MGB-BP-3, is a potent bactericidal antibiotic with a completely novel mode of action. It is an oral formulation being developed specifically for the treatment of CDAD, with the first cohort of patients having now completed treatment.
The company confirmed that a Safety Committee review of the first cohort reported no concerns and recruitment of patients in the next cohort is progressing at sites in both Canada and the US. Headline results from all three cohorts are anticipated in early 2020.
To date, MGB-BP-3 is the only antibiotic that has the killing power, combined with the speed of action, to eradicate CDAD within the first few hours of exposure, helping to prevent the bacteria evading therapy via sporulation.
Dr Miroslav Ravic, chief executive officer of MGB Biopharma, said: “We are delighted to have completed the first of three patient cohorts in our Phase IIa study. As this is an open-label study, we are able to see how the drug performs on an ongoing basis and are encouraged by what we have seen so far.
“Given its unique properties, we remain confident that MGB-BP-3 could represent a new paradigm for the treatment of CDAD, a potentially life-threatening infection.”
CDAD is a serious and life-threatening infection of the large intestine and is the most frequent cause of diarrhoea in hospitals and care homes. The disease also presents itself as abdominal cramps, fever and leukocytosis, and in some severe cases a pseudo-membranous colitis may develop which can be life-threatening.