MGB Biopharma Announces Promising Phase IIa Clinical Trial Update for MGB-BP-3, a Novel, Potent Bactericidal Antibiotic Targeting Clostridium difficile-Associated Diarrhoea (CDAD)

Thursday, October 10, 2019 General News
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GLASGOW, Scotland, Oct. 10, 2019 /PRNewswire/ -- 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.

About MGB-BP-3

MGB-BP-3 has two principal features that distinguish it from existing CDAD therapy. Firstly, it has a very fast bactericidal effect which, in contrast to current CDAD treatment, is able to kill C. difficile in its vegetative form before it can sporulate, thus speeding up recovery and preventing the disease from recurring. Secondly, MGB-BP-3 has very strong bactericidal activity against the BI/NAP1/027 strain, the most virulent strain which is largely resistant to current therapy.

About MGB Biopharma

MGB Biopharma is a clinical stage company developing a novel class of anti-infectives. Its lead candidate, MGB-BP-3, is being developed as an oral formulation of MGB-BP-3 for the treatment of Clostridium difficile-associated diarrhoea (CDAD).

In addition to its C. difficile programme, MGB Biopharma has a pipeline of early preclinical compounds against Gram-positive, Gram-negative, and anti-fungal pathogens.

MGB Biopharma acquired rights to the proprietary minor groove binder (MGB) platform, developed at the University of Strathclyde, Glasgow, with exclusive worldwide licensing rights for all anti-infective fields, including Gram-negative bacteria. This platform provides an opportunity to develop various compounds with a completely new mode of action which are distinct from the antimicrobial drugs used in clinical practice today. As a result, many MGB-based drugs have the potential to offer significant advantages over existing anti-infectives, for example, MGB-BP-3, which exhibits high efficacy against many multi-drug susceptible and resistant Gram-positive pathogens. To date, no resistance to MGB compounds has been observed.

The Company intends to work with partners to fully capitalise on the multiple value creating opportunities offered by its broad and innovative anti-infectives platform.

The Company, founded in 2010 and headquartered in Glasgow, Scotland, is backed by Scottish investors including Archangel Investors Limited, Barwell, TRICap, Syndicate Room and the Scottish Investment Bank, Scottish Enterprise.

For more information please visit www.mgb-biopharma.com

For further information, please contact:

MGB BiopharmaChris Wardhaugh, Chief Business Officercwardhaugh@mgb-biopharma.com+44(0)1698-464224

Citigate Dewe RogersonDavid Dible, Sylvie Berrebidavid.dible@citigatedewerogerson.comsylvie.berrebi@citigatedewerogerson.com+44(0)20-7638-9571

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SOURCE MGB Biopharma



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