Cambridge, Massachusetts-based Seres announced positive topline results from a pivotal Phase 3 study, dubbed ECOSPOR III, that is evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection.
The study met the primary endpoint of showing a statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks of administration of SER-109 versus placebo, the company said.
Additionally, 11.1% of patients in the treatment arm experienced a CDI recurrence versus 41.3% in the control arm, Seres said.
“The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective,” according to the biopharma.
With the study’s efficacy results exceeding the previously established regulatory statistical threshold, this single clinical study will likely fulfill efficacy requirements for a BLA submission, the company said.
The investigational asset’s safety results were favorable.
Why It’s Important: Recurrent CDI, a bacterial infection that causes symptoms ranging from diarrhea to life-threatening colon inflammation, is a serious disease that affects the quality of life of patients and could eventually lead to death in cases of severe infection.
Today’s treatment options leave much to be desired in terms of efficacy, safety and route of administration, Seres said.
“Based on these highly positive SER-109 ECOSPOR III results, we believe that this novel microbiome therapeutic candidate could potentially provide a much-needed effective oral treatment option for the approximately 170,000 patients in the U.S. that suffer from recurrent CDI annually,” Chief Medical Officer Lisa von Moltke said in a statement.
What’s Next? Seres said it aims to meet with the FDA to discuss the regulatory path for SER-109.
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