Glasgow, Scotland, 10 October 2019 – MGB Biopharma, a biopharmaceutical company developing
a novel class of anti-infectives to address the major global problem of antibiotic resistance, today
announces an update on progress in its Phase IIa clinical study.
MGB-BP-3 is a potent bactericidal antibiotic with a completely novel mode of action. An oral
formulation is being developed specifically for the treatment of Clostridium difficile-associated
MGB Biopharma’s ongoing Phase IIa trial is assessing the safety, tolerability and efficacy of
incremental doses of MGB-BP-3 in patients with CDAD, with the cure rate assessed after completion
of 10-day therapy and at follow-up of up to 8 weeks. The open-label study is structured to treat
patients at ascending dose levels of MGB-BP-3, in three different cohorts. In addition to its primary
endpoints the study will also assess the impact of MGB-BP-3 on the microbiome.
The first cohort of patients has now completed treatment with the lowest dose and results indicate
high efficacy and good tolerability of MGB-BP-3. 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 C. difficile within the first few hours of exposure, helping to prevent the bacteria
evading therapy via sporulation. Importantly, MGB-BP-3 has very strong bactericidal activity
against the BI/NAP1/027 strain, the most virulent strain of C. difficile, which is largely resistant to
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. In the US alone there are almost half a million cases every
year leading to around 30,000 deaths per annum.
Dr Miroslav Ravic, CEO 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.”
The Company acknowledges the support to the funding of its Phase IIa trial with MGB-BP-3 from an
award from Innovate UK, the Biomedical Catalyst Fund. The Company also acknowledges the
support of University of Strathclyde where MGB-BP-3 was discovered and initially developed.