Glasgow, Scotland, 12th September 2016 – MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announces today that the US Food and Drug Administration (FDA) has granted MGB-BP-3, MGB Biopharma’s lead product, Qualified Infectious Disease Product (QIDP) designation for the Treatment of Clostridium difficile-associated Diarrhoea (CDAD). The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by “qualified pathogens”.
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 cases of infectious hospital-acquired diarrhoea in developed countries.
Successful completion of the clinical Phase I study of MGB-BP-3 confirmed the compound 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. MGB is preparing to initiate the Phase II clinical study for MGB-BP-3 and investigate the safety and efficacy in patients with CDAD, caused by the most virulent ribotype of C. difficileB1/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 Miroslav Ravic, CEO of MGB Biopharma, said: “We are very pleased with the FDA’s decision to grant QIDP designation to MGB-BP-3 as we believe this drug has the potential to provide a significant benefit in the treatment of Clostridium difficile-associated Diarrhoea (CDAD). Granting of the QIDP designation highlights the potential of MGB-BP-3 to address serious and life-threatening infections and is an important milestone in the development of our lead product, as we prepare to initiate the Phase II clinical trial. ”
Dr Ravic, added: “Around the world, governments and global organisations are calling for new anti-bacterial drugs and are introducing incentives to reward companies for delivering these products; only last week antimicrobial resistance (AMR) was on the agenda of the G20 Summit.
Our MGB-based anti-infectives have the potential to deliver significant advantages over current approaches.”
While pursuing its clinical development activities, MGB Biopharma is now evaluating partnering and funding sources for its lead compound MGB-BP-3, which has the potential to offer a clear differentiated treatment option for patients with life threatening infections caused by resistant and susceptible Clostridium difficile strains.
For further information, please contact:
|MGB BiopharmaMiroslav Ravic, Chief Executive Officer
Dr Dawn Firmin, Head of Project Management
+44 (0) 208 946 0120
|Citigate Dewe RogersonDavid Dible, Sylvie Berrebi
+44 (0) 20 7282 1052
The QIDP designation program was established by the U.S. Congress in 2012 as part of the Generating Antibiotic Incentives Now (GAIN) Act in order to provide incentives to drug manufacturers to develop new antibiotics for serious, antibiotic-resistant, bacterial and fungal infections. QIDP also paves the way for FDA to apply greater regulatory flexibility in the case of high unmet medical need for serious, life-threatening infections. It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
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 has developed an oral formulation of MGB-BP-3 for the treatment of Clostridium difficile associated disease (CDAD). 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, 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 and the Scottish Investment Bank, Scottish Enterprise.
For more information please visit www.mgb-biopharma.com
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