Clostridium

Seres Therapeutics has obtained orphan drug status from the US Food and Drug Administration (FDA) for its SER-109 to prevent recurrent Clostridium difficile infection (CDI) in adults.

SER-109 is an oral therapeutic that is being investigated as a new therapeutic modality to treat recurrent CDI by correcting a dysbiosis of the human microbiome.

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Seres Therapeutics 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."

According to the firm, results from a phase one b / two study of SER-109 in recurrent CDI patients demonstrated that 87% of patients achieved efficacy endpoint per protocol and 97% of patients achieved a clinical cure.

"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."

Currently, Seres is carrying out a multicentre, randomised and placebo-controlled phase two clinical study to evaluate the efficacy and safety of SER-109 in preventing recurrent CDI.

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The trial’s primary outcome measure is the absence of CDI through eight weeks following administration of SER-109 compared to placebo.

Seres plans to reveal the results of the study in the middle of 2016.

The company developed SER-109 by using its Microbiome Therapeutics platform, which provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyse a shift to a healthier state.

Image: C. difficile colonies on a blood agar plate. Photo: courtesy of CDC/Dr. Holdeman.