Seres Therapeutics has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its SER-109 (firmacute eubacterial spores, purified suspension, encapsulated).
SER-109 is the firm’s lead product candidate under investigation to prevent recurrent Clostridium difficile infection (CDI) in adults.
Developed by using the Seres Microbiome Therapeutics platform, SER-109 is the Seres Ecobiotic microbiome therapeutic in clinical testing to treat recurrent CDI.
Seres Microbiome Therapeutics platform is said to provide insight into the ecologies of disease and then identifies microbial composition.
Seres Therapeutics president and CEO Dr Roger Pomerantz said: "Recurrent CDI is a life-threatening condition affecting between 85,000 and 110,000 people each year in the US.
"We are encouraged by the FDA’s grant of breakthrough therapy designation for SER-109 and the potential for an expedited review by the FDA of our lead product candidate."
The company is carrying out a multi-centre, randomised and placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SER-109 in prevention of recurrent CDI.
According to the firm, the study’s primary outcome measure is the absence of CDI through eight weeks, following administration of SER-109 compared to placebo.
Seres will administer SER-109 as a single dose, following administration of the standard of care antibiotics for CDI.
Expected to be carried out at around 35 centres across the US, the trial is actively enrolling the patients that is estimated to complete by mid-2016.
Image: The photograph depicts Clostridium difficile colonies after 48 hour growth on a blood agar plate. Photo: courtesy of CDC/Dr. Holdeman.