MGB Biopharma's Pre-IND Meeting With FDA Provides Clear Guidelines on Further Development of Oral MGB-BP-3, a Truly Novel Antibiotic Targeting Clostridium Difficile Infections

May 09, 2016, 03:00 ET from MGB Biopharma

GLASGOW, Scotland, May 9, 2016 /PRNewswire/ --

MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives to address the major global problem of antibiotic resistance, announces that it has held a pre-Investigational New Drug (pre-IND) meeting with the Food and Drug Administration (FDA) to discuss the regulatory strategy for the development programme of MGB-BP-3 in the US.

MGB Biopharma presented available Phase I and pre-clinical data together with a proposal for the further clinical development of oral MGB-BP-3 in Clostridium difficile infections (CDI). Following this positive meeting, MGB Biopharma are now in the process of obtaining a designation of Qualified Infections Disease Product (QIDP) status for MGB-BP-3, and are starting to prepare for the clinical Phase II study.

MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible 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 the majority of infectious hospital-acquired diarrhoea in developed countries.

Successful completion of the clinical Phase I study confirmed MGB-BP-3 was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora.

Dr Miroslav Ravic, CEO of MGB Biopharma, said, "We are extremely pleased with the support we have received from the FDA with regards to our plans to further progress the clinical development of oral MGB-BP-3. We are now planning to initiate a Phase II clinical trial and investigate the safety and efficacy of MGB-BP-3 in patients with CDI, caused by the most virulent ribotype of C. difficile known as C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy."

Dr Ravic added, "Our discussions with the FDA have provided clear guidelines on the development path we need to take to bring our truly novel antibiotic MGB-BP-3 to market in the shortest possible time. In parallel with our clinical development activities we are now evaluating partnering and funding sources for this exciting opportunity, which we believe will offer a clearly differentiated treatment option for patients with life threatening infections caused by resistant Clostridium difficile."

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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 and susceptible Gram-positive pathogens. The Company has developed an oral formulation of MGB-BP-3 for the treatment of Clostridium difficile. The Phase I study is complete, and MGB Biopharma is now progressing with Phase II activities for this indication. 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 showed encouraging efficacy data.

MGB Biopharma has 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 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 http://www.mgb-biopharma.com.

For further information, please contact:
MGB Biopharma
Miroslav Ravic
Chief Executive Officer
Or
Dr Dawn Firmin, Head of Project Management
enquiries@mgb-biopharma.com
+44 (0) 208 946 0120

Citigate Dewe Rogerson
David Dible, Sylvie Berrebi
david.dible@citigatedr.co.uk
Sylvie.berrebi@citigatedr.co.uk
+44 (0) 20 7282 1052

SOURCE MGB Biopharma