FDA orphan and breakthrough designation given to SER-109 for the prevention of recurrent Clostridium difficile infection (CDI)

FDA orphan and breakthrough designation given to SER-109 for the prevention of recurrent Clostridium difficile infection (CDI)

"The US Food and Drug Administration (FDA) has granted orphan designation to SER-109 for the prevention of recurrent Clostridium difficile infection (CDI) in adults.

SER-109 is a microbiome therapeutic designed to treat recurrent CDI by correcting dysbiosis of the human microbiome.

In a single dose of 4 capsules, SER-109 re-introduces an ecology of purified bacterial spores that should restore the microbiome to a healthy state, allowing it to carry out key biological functions, including resisting Clostridium difficile."

More from Hematology Times (free membership), including information on phase 1/2 trial progress:

hematologytimes.com/p_artic...

This may be good news for those that don't like the idea of a faecal transplant!

Neil

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  • And in related news, the two most common antibiotic resistant bugs found circulating in hospitals: vancomycin-resistant Enterococcus faecium (VRE) and multi-drug resistant Klebsiella pneumonia, can be wiped out by transplanting faeces from a healthy animal into the gut of an infected one, a study on mice has found:

    theconversation.com/poo-tra...

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