MGB Biopharma commences Phase I clinical trial with oral formulation of MGB-BP-3 for treatment of multi-resistant Clostridium Difficile infections

23-Jul-2015 - United Kingdom

MGB Biopharma 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.

https://www.bionity.com/en/news/153771/mgb-biopharma-commences-phase-i-clinical-trial-with-oral-formulation-of-mgb-bp-3-for-treatment-of-multi-resistant-clostridium-difficile-infections.html