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news.Seres Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for its oral therapeutic, SER-109, being evaluated in a Phase II clinical trial for the prevention of recurrent Clostridium difficile infection (CDI) in adults.
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Currently, SER-109 is being examined 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.
CDI is one of the US Centers for Disease Control’s top three most urgent antibiotic-resistant bacterial threats and is responsible for the deaths of about 29,000 Americans each year.
Seres chairman, president and CEO Roger Pomerantz said: "SER-109 is intended to re-introduce essential bacteria that restore the body’s natural resistance to CDI by re-establishing the ecology of the colonic microbiome.
"Because we’re focused on treating the underlying cause of the disease, we believe we have the potential to break the cycle of recurrent CDI and have a significant impact for patients."
Results from the company’s Phase Ib/II trial 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.
Currently, the company is conducting a multicenter, randomized, placebo-controlled Phase II trial to evaluate 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 the Phase II trial are expected to be reported in the middle of 2016.
The company said that SER-109 was developed using its Microbiome Therapeutics platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to a healthier state.