New Microbiome Therapy Granted Orphan Drug Designation for Recurrent CDI

New Microbiome Therapy Granted Orphan Drug Designation for Recurrent CDI
New Microbiome Therapy Granted Orphan Drug Designation for Recurrent CDI

Seres Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to SER-109, an oral agent currently in a Phase 2 clinical trial for the prevention of recurrent Clostridium difficile infection (CDI) in adults. SER-109 is being investigated as a new therapeutic modality to treat recurrent CDI by correcting a dysbiosis of the human microbiome, which is an underlying cause of the condition.

Results from a Phase 1b/2 study of SER-109 in recurrent CDI patients showed that 87% of patients achieved efficacy endpoint per protocol, and 97% of patients achieved a clinical cure, which was defined as the absence of CDI requiring antibiotic treatment during the eight-week period after SER-109 dosing.

RELATED: CDC: Action Needed to Better Control Drug-Resistant Infections

Seres is currently conducting a multicenter, randomized, placebo-controlled Phase 2 clinical study to assess the efficacy and safety of SER-109 in preventing recurrent CDI. The primary outcome measure is the absence of CDI through eight weeks following administration of SER-109 compared to placebo. Results from this study are expected to be available in the middle of 2016.

For more information visit SeresTherapeutics.com.

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