Eric Shaff, president and CEO of Seres Therapeutics, discusses the confirmatory trial findings for SER-109. Seres is filing a Biologics License Application for the recurrent C diff therapy.
Clostridioides difficile (C diff) infection is the most common healthcare-associated infection in the US, accounting for significant patient mortalities and draining hospital resources. Recurrent C diff infection (rCDI) is associated with even higher patient deaths, and is recognized as an urgent public health threat.
Seres Therapeutics recently announced confirmatory results from a clinical study of SER-109, their investigational oral microbiome therapeutic for recurrent C difficile infection.
Eric Shaff, the president and CEO of Seres, was excited to share the implications of the positive trial results: “SER-109 is really the centerpiece of the company.”
“What if we could take this concept of fecal transplant and make it orally administered?” Shaff explained, “That was the catalyst behind the initiation of the company.”
“There really hasn’t been meaningful innovation in recurrent C diff,” Shaff said, explaining that the antibiotics with which patients are typically treated can actually make things worse. When excess antibiotics wipe out the healthy bacteria in the gut microbiome, resilient C diff bacteria has the space and nutrients to flourish.
“SER-109 is intended to repopulate that natural ecosystem of bacteria that’s necessary to prevent the recurrence of C diff infection,” Shaff said.
In the phase 3 open-label clinical trial ECOSPOR IV, SER-109 demonstrated a sustained response rate of 91.3% in patients with a history of recurrent C diff infection. In light of these positive results, Seres has begun the rolling submission for SER-109’s Biologics License Application (BLA).
Shaff anticipates the BLA submission will be completed by the middle of this year, when it will then be reviewed by the US Food and Drug Administration (FDA). Simultaneously, Seres is preparing for the global launch of SER-109.
“We’re making SER-109, we’re continuing to scale up our ability to produce the product, because we think this is going to be a global product, not just a US product,” Shaff said. “We think that patients worldwide can be served with SER-109.”