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MGB Biopharma begins Phase I trial of oral MGB-BP-3 to treat clostridium difficile infections

Scotland-based biopharmaceutical firm MGB Biopharma has dosed the first group of healthy male volunteers in a Phase I clinical trial evaluating the safety and tolerability of an oral formulation of MGB-BP-3, to treat Clostridium difficile infections.

MGB-BP-3 is an antibiotic that has been shown to be active against a broad range of important multi-resistant Gram-positive pathogens.

The company has developed the oral formulation of MGB-BP-3 specifically to treat Clostridium difficile, a Gram-positive bacterium responsible for a growing number of hospital acquired infections.

Around 40 healthy subjects will be enrolled in the trial, which will determine the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of oral MGB-BP-3.

The single centre, double-blind, placebo controlled Phase I trial will also examine the effect of MGB-BP-3 on normal gut flora.

Results from this trial are expected to be reported by the end of this year.

MGB Biopharma CEO Miroslav Ravic said: "The start of the Phase I clinical trial with our oral formulation of MGB-BP-3 is a major milestone for the company. Infections by multi-resistant Gram-positive pathogens, such as Clostridium difficile, are a growing worldwide problem that causes many deaths and higher morbidity in patients being treated in hospital.

"MGB-BP-3 has the potential to be the first truly novel antibiotic with a novel mode of action developed in more than a decade capable of treating infections of this type."

The company is also developing an intravenous formulation targeting the treatment of a range of systemic hospital acquired Gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA).

According to the company, the IV formulation is expected to be IND-ready by this year end.