Dive Brief:
- Leading microbiome company Seres Therapeutics on Friday announced the company's lead candidate, SER-109, had failed to meet its phase 2 trial's primary endpoint of reducing Clostridium Difficile (C. diff) infection recurrence at up to 8 weeks.
- SER-109 failed to show a statistically significant reduction in the risk of recurrence, with 44% of SER-109 subjects experiencing CDI recurrence at 8 weeks compared to 53% on placebo.The phase 2 trial was the first placebo-controlled and blinded study in the emerging microbiome field, according to the company.
- Expectations were high for Seres, the first publicly traded microbiome company, after it raised $130 million through its IPO. But the unexpected failure led to a 76% drop in the company's stocks during morning trading Friday.
Dive Insight:
Microbiome technology seeks to use microbial therapies to reset the body's equilibrium in the hopes of reducing the adverse effects caused by drugs.
Although Seres is not the only company attempting to explore the relationship between the microbiome and the human body, the SER-109 phase 2 trial was the largest trial in the field to date.
But the company remained optimistic despite the trial's failure, emphasizing the technology is new and, like any new technology, had to fail at some point.
"We think that SER-109 actually is a good way of getting at this for the first time," said Roger Pomerantz, President, CEO and Chairman of Seres. "We are sort of pioneering this, if you look at the literature it is not at all clear that we know the placebo rate for fecal transplants," he added after comparing the technology to the early years of the immuno-oncology and gene therapy fields.
SER-109 was designed to treat C. difficile infections, a healthcare associated infection affecting the gastrointestinal system following antibiotic therapies or extended stay in care facilities. According to the Center for Disease Control and Prevention, nearly half a million people were infected with the disease in 2011 and 29,000 of these died within 30 days of diagnosis.
"C. Difficile infection treatment options, including unregulated fecal microbial transplants, remain poor," said Pomerantz. "The confounding placebo data obtained in this study further highlight the significant need for new, effective, FDA regulated therapeutic options for these patients. We will take our learnings from this study and continue in our pioneering efforts to develop meaningful new microbiome therapeutics for C. Difficile infection and other serious diseases.”
Most microbiome research has centered on diseases affecting the gut, but in May the White House announced its National Microbiome Initiative supporting research to expand and better understand the technology field through a variety of private-public partnerships.