MGB Biopharma Announces Promising Phase IIa Clinical Trial Update for MGB-BP-3

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

disease (CDAD).

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

current therapy.

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.

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