MGB Biopharma has announced that the first group of healthy male volunteers have been dosed in a Phase I clinical trial assessing the safety and tolerability of an oral formulation of MGB-BP-3, for use in the treatment of 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 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 a growing number of hospital acquired infections.
Approximately 40 healthy subjects will be enrolled into the single centre, double-blind, placebo controlled, Phase I trial, which will determine the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of oral MGB-BP-3. The trial will also examine the effect of MGB-BP-3 on normal gut flora.
Of the 40 subjects enrolled, approximately 16 will receive a single dose of MGB-BP-3 or placebo in up to 3 study sessions, the first of which has been completed successfully. A further 24 subjects will receive twice-daily, ascending, oral doses of MGB-BP-3 or placebo for 9 days, and a single dose on the morning of day 10. All subjects will attend a follow-up visit at 7–10 days after their dose of trial medication.
The results of the trial are expected by the end of 2015.
Miroslav Ravic, CEO of MGB Biopharma, 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.”
MGB Biopharma is also developing an intravenous formulation targeting the treatment of a range of systemic hospital acquired Gram-positive infections, including MRSA. This programme is in late-stage preclinical development, and shows very promising results. The IV formulation is expected to be IND-ready by the end of 2015.