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news.MGB Biopharma 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.
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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."