MGB Biopharma commences Phase I clinical trial with oral formulation of MGB-BP-3 for the treatment of multi-resistant Clostridium Difficile infections

MGB Biopharma is at the forefront of efforts to tackle the global rise in antibiotic resistant infections

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Glasgow, Scotland, 21st July 2015 – MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives, to address the major global problem of antibiotic resistance today announces that the first group of healthy male volunteers have been dosed in a Phase I clinical trial assessing the safety and tolerability of an oral formulation of MGB-BP-3, for use in the treatment of Clostridium difficile infections. 

MGB-BP-3 is an antibiotic that has been shown to be active against a broad range of important multi-resistant Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for a growing number of hospital acquired infections.

Approximately 40 healthy subjects will be enrolled into the single centre, double-blind, placebo controlled, Phase I trial, which will determine the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of oral MGB-BP-3. The trial will also examine the effect of MGB-BP-3 on normal gut flora.

Of the 40 subjects enrolled, approximately 16 will receive a single dose of MGB-BP-3 or placebo in up to 3 study sessions, the first of which has been completed successfully. A further 24 subjects will receive twice-daily, ascending, oral doses of MGB-BP-3 or placebo for 9 days, and a single dose on the morning of day 10. All subjects will attend a follow-up visit at 7–10 days after their dose of trial medication.

The results of the trial are expected by the end of 2015.

Miroslav Ravic, CEO of MGB Biopharma, said: “The start of the Phase I clinical trial with our oral formulation of MGB-BP-3 is a major milestone for the company. Infections by multi-resistant Gram-positive pathogens, such as Clostridium difficile, are a growing worldwide problem that causes many deaths and higher morbidity in patients being treated in hospital. MGB-BP-3 has the potential to be the first truly novel antibiotic with a novel mode of action developed in more than a decade capable of treating infections of this type.”

MGB Biopharma is also developing an intravenous formulation targeting the treatment of a range of systemic hospital acquired Gram-positive infections, including MRSA. This programme is in late-stage preclinical development, and shows very promising results. The IV formulation is expected to be IND-ready by the end of 2015.

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For further information, please contact:

MGB Biopharma                                                                          Citigate Dewe Rogerson

Miroslav Ravic, Chief Executive Officer                                      David Dible

Or                                                                                                     david.dible@citigatedr.co.uk

Dr Dawn Firmin, Head of Project Management                        +44 (0) 20 7282 2949

enquiries@mgb-biopharma.com

+44 (0) 208 946 0120

 

About MGB Biopharma

MGB Biopharma, is a clinical stage company developing a truly novel class of anti-infectives. Its lead candidate, MGB-BP-3, is an antibacterial which is active against a broad range of important multi-resistant Gram-positive pathogens. The Company has developed an oral formulation of MGB-BP-3 for the treatment of Clostridium difficile, currently in Phase I. An intravenous formulation targeting the treatment of a range of systemic hospital acquired Gram-positive infections is in late-stage preclinical development, and a topical formulation for the treatment of serious skin infections is undergoing feasibility assessment.

MGB Biopharma has acquired the proprietary minor groove binder (MGB) platform, developed at the University of Strathclyde, Glasgow, with exclusive worldwide licensing rights for all anti-infective fields. 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. Consequently many MGB-based drugs offer significant advantages over existing anti-infectives, such as 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, Barwell, TRI Cap and the Scottish Investment Bank, Scottish Enterprise.

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

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