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Phase I clinical trial of oral formulation of MGB-BP-3 for treatment of Clostridium Difficile infections begins
21 July 2015 • Author: Victoria White
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.
Phase 1 trial results for the oral formulation of MGB-BP-3 expected by the end of this year
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.”
The results of the trial are expected by the end of 2015.
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.
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