Clostridium difficile infection (“CDI”) is established as a persistent and significant problem in the primary healthcare system. The clinical manifestations of fulminant CDI signify a very severe condition with the possible development of pseudomembraneous colitis, toxic megacolon, bowel perforation, sepsis and death. However, the key clinical issue with CDI is recurrent disease, with up to 30% of patients experiencing at least one recurrent period of CDI following initial therapy. Each period of recurrent disease is associated with an increased risk of further recurrent periods, increased disease severity and increased mortality rates. Recurrent disease is frustratingly difficult to treat and results in a significant detrimental impact on patient welfare and disease progression and is associated with major economic and resource repercussions to the healthcare system.

The recently emerged hyper-virulent C. difficile strain BI/NAP1/027 (which accounts for around 30% of EU cases and 50% of cases in North America) is associated with increased toxin production, compared with non-hypervirulent strains. These hypervirulent strains result in more severe forms of the disease, increased risk of life threatening complications, increased rates of recurrent disease and an increase in associated mortality rates. No drugs in current use or in development for CDI have shown statistically significant reduction in recurrence rates of CDI from these hypervirulent strains.

Clostridium difficile: A spore forming Gram-positive bacteria, located in the intestine, associated with antibiotic use.
Clostridium difficile: A spore forming Gram-positive bacteria, located in the intestine, associated with antibiotic use.

 

Differentiation of MGB-BP-3 in Clostridium difficile Infection

  1. Broad in vitro activity confirmed against Clostridium difficile
  2.  Rapid killing effect seen for MGB-BP-3 against C. diff strains, including hyper-virulent NAP1/027; activity superior to vancomycin
  3. Superior activity to vancomycin confirmed in vivo
  4. MGB-BP-3 is superior to vancomycin in suppressing sporulation in all C. difficile strains tested
  5. MGB-BP-3 is active against vancomycin resistant enterococci (VRE)
Phase I Clinical Trials: Oral MGB-BP-3 is currently in Phase I safety and tolerability studies in healthy volunteers, conducted at Hammersmith Medical Research, London.
Phase I Clinical Trials: Oral MGB-BP-3 has recently completed a Phase I safety and tolerability study in healthy volunteers, conducted at Hammersmith Medical Research, London.
Our oral programme: MGB has successfully formulated, optimised and manufactured enterically coated, liquid-fill capsules of 250mg MGB-BP-3, for use as an oral treatment of Clostridium difficile.
Our oral programme: MGB has successfully formulated, optimised and manufactured enterically coated, liquid-fill capsules of 250mg MGB-BP-3, for use as an oral treatment of Clostridium difficile.

 

 

 

 

 

 

 

 

 

 

 

 

Oral MGB-BP-3 has recently completed a Phase I clinical trial to assess safety and tolerability in healthy volunteers.This study was a single centre, double-blind, placebo-controlled, crossover study of single (SAD) and multiple (MAD) ascending doses of MGB-BP-3.