MGB Biopharma - FDA and Health Canada Clear IND/CTA Applications for MGB-BP-3, a Novel, Potent Bactericidal Antibiotic Targeting Clostridium difficile-Associated Diarrhoea (CDAD)

GLASGOW, Scotland, January 24, 2019 /PRNewswire/ --

Phase IIa trial to evaluate MGB-BP-3 in patients with CDAD on track to start in Q1 2019

MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announces that the Food and Drug Administration (FDA) and Health Canada have cleared Investigational New Drug applications (IND/CTA) for its lead candidate MGB-BP-3. The Company intends to commence its dose-range finding Phase IIa clinical trial, in the US and Canada, on MGB-BP-3 for the treatment of Clostridium difficile-associated diarrhoea (CDAD) in Q1 2019.

MGB-BP-3 is a potent bactericidal antibiotic with a completely novel mode of action that is active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed specifically for the treatment of CDAD, an infection to which the most frequent occurrence of diarrhoea in hospitals in developed countries is attributed. These infections have a high mortality rate, with 1 out of every 11 patients aged 65 or older dying within 30 days of diagnosis.

MGB Biopharma believes that MGB-BP-3 has the potential to offer a new paradigm in the treatment of CDAD because it kills C. difficile very quickly whilst still in its vegetative form, before it sporulates. The amount of dormant C. difficile spores formed during therapy with MGB-BP-3, compared to the amount formed during therapy with alternative bacteriostatic antibiotics, should therefore be reduced, resulting in a significant reduction of disease recurrence. MGB-BP-3 has also shown a strong bactericidal effect against hypervirulent strain BI/NAP1/027 (in addition to other tested strains), which is less responsive to current antibacterial therapy.

The planned Phase IIa trial will assess the initial cure and sustained cure rates that MGB-BP-3 delivers in the treatment of CDAD. Dr Thomas Louie, a clinical professor at the Cumming School of Medicine at the University of Alberta, Calgary (Canada) will be the trial's Principal Investigator. Headline results from the trial are anticipated in Q3 2019.

Dr Louie said: "C. difficile infection represents a major burden to the Canadian and US healthcare systems. A novel antibiotic that is able to kill this deadly pathogen before it is able to sporulate offers new hope to patients and their families who suffer the pain and misery caused by this disease."

Dr Miroslav Ravic, CEO of MGB Biopharma, said: "We are delighted that the FDA and Health Canada have cleared our IND/CTA applications. Our Phase IIa trial will mark a significant milestone in the progress of MGB-BP-3. We believe that having a bactericidal antibiotic like MGB-BP-3 available, which is able to kill bacteria before sporulation, will clearly offer a differentiated treatment option for patients with life threatening infections caused by resistant or hyper-virulent C. difficile. We are looking forward to working with Dr Louie, a well-known expert in the treatment of CDAD, to start a Phase IIa trial in the coming months. This trial will be a key step in bringing MGB-BP-3 closer to the market."

C. difficile Infection 

Clostridium difficile (C. difficile) caused almost half a million infections among patients in the US in a single year, according to a study released by the Centers for Disease Control and Prevention (CDC) in 2015.

1 out of every 5 patients with a healthcare-associated C. difficile infection experienced a recurrence of the infection, and 1 out of every 11 patients aged 65 or older with a healthcare-associated C. difficile infection died within 30 days of diagnosis.

Previous studies indicate that C. difficile has become the most common cause of healthcare-associated infection in US hospitals and costs up to $4.8 billion each year in excess healthcare costs for acute care facilities alone. There is currently no vaccine or approved product for the prevention of C. difficile infection.

About MGB Biopharma 

MGB Biopharma is a clinical stage company developing a 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 and susceptible Gram-positive pathogens. The Company is developing an oral formulation of MGB-BP-3 for the treatment of Clostridium difficile-associated diarrhoea (CDAD).

MGB Biopharma believes that MGB-BP-3 will offer a much-improved treatment option for CDAD because its bactericidal activity will prevent bacterial sporulation, the key reason that these infections recur in about 20% of patients.

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, TRI Cap, Syndicate Room and the Scottish Investment Bank, Scottish Enterprise.

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

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