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MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announces today that it has raised $1.15 million in a financing round with existing investors.
The Company will use these funds to advance its lead product, MGB-BP-3, towards a Phase II clinical trial. The Phase II study is designed to investigate the safety and efficacy in patients with Clostridium difficile-associated disease (CDAD) caused by Clostridium difficile, including the most virulent ribotype, B1/NAP1/027.
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 Clostridia class of normal gut flora.
The investment round was led by Archangel Investors Ltd and included TRI Capital Ltd, Barwell plc and Scottish Investment Bank, the investment arm of Scottish Enterprise.
Dr Miroslav Ravic, CEO of MGB Biopharma, said: “Thanks to the continued support of our investors, we have closed our latest financing round with a $1 million extension. These funds will allow us to complete manufacturing of clinical supply for the Phase II clinical trial for MGB-BP-3’s oral formulation to investigate the safety and efficacy in patients with CDAD. Following the potential and successful completion of the study, we expect that only one single Phase III superiority study will be required before registration. We shall also continue the development of an intravenous formulation for AMR systemic infection.”
Dr Ravic added: “In parallel with our development activities we are now evaluating partnering and further 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 or hyper-virulent Clostridium difficile.”
MGB-BP-3 was granted Qualified Infectious Disease Product (QIDP) status by the Food and Drug Administration (FDA), gaining additional 5-years market exclusivity. The FDA provided clear guidelines for a Phase II and signalled support for a single Phase III superiority study protocol for MGB Biopharma’s lead compound.
For further information, please contact:
Dr Miroslav Ravic, Chief Executive Officer
Dr Dawn Firmin, Head of Project Management
+44 (0) 208 946 0120
Citigate Dewe Rogerson
David Dible, Sylvie Berrebi
+44 (0) 20 7282 1052
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). With the completion of the Phase I study, MGB Biopharma is now preparing for a Phase II study 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
Or follow MGB Biopharma on Twitter @MGB_Biopharma