Seres Therapeutics, Inc. announced that the company’s Phase III Ecospor IV study demonstrated a strong safety profile in addition to statistically significant positive results against C. difficile infection.
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Massachusetts-based Seres Therapeutics, Inc. announced Tuesday that its Phase III Ecospor IV study demonstrated a strong safety profile in addition to statistically significant positive results. The study uses an open-label design to determine the potential of SER-109, a potentially first-in-class microbiome therapeutic to treat recurrent C. difficile infection (rCDI).
The study is placebo-controlled, double-blinded and randomized. The primary outcome measurement focuses on the participants’ infection recurrence after treatment for eight weeks. Infection is confirmed using a toxin assay. Secondary outcome measures evaluate recurrence rates at the 4, 12 and 24-month marks within each treatment group. Additional measurements look at the time to infection recurrence and tolerability of the treatment.
SER-109 is an orally delivered therapeutic that provides purified firmicutes to the patient’s microbiome to prevent C. difficile colonies from forming. Firmicutes are a classification of bacteria that are critical to gut health, which in turn, plays a significant role in overall metabolic function. The candidate’s unique mechanism influenced the U.S. Food and Drug Administration’s (FDA) decision to grant Breakthrough Therapy and Orphan Drug designations for SER-109 when indicated to treat rCDI.
Eric Shaff, president and chief executive officer at Seres, commented on the results.
“The Ecospor IV data confirm the well-tolerated safety profile and clinical benefit observed in the prior Ecospor III study,” he said. “These results, along with the start of the rolling BLA submission, significantly advance our ability to deliver what may be the first FDA-approved microbiome therapeutic. We believe that SER-109 has the potential to fundamentally transform the management of rCDI across all 170,000 annual cases in the U.S. and are working closely with Aimmune Therapeutics, a Nestlé Health Science Company, to bring this therapeutic candidate to patients as quickly as possible.”
According to Mayo Clinic, recent antibiotic use is not necessary for suspecting a diagnosis of rCDI. However, if antibiotic use is the culprit, that particular antibiotic regimen must be stopped. Other antibiotics might be prescribed to remedy the damage caused and clear up the infection, such as vancomycin, fidaxomicin and/or metronidazole.
Mayo Clinic goes on to explain that a quarter of infected persons experience recurrence, with the risk of recurrence multiplying each time. After contracting three infections, over 50% of patients will have to battle the infection once again. Patients most likely to fall victim to rCDI are over the age of 65, have an underlying gastroenterological medical condition or are simultaneously being treated for two conditions with antibiotics.
Non-traditional treatments, such as fecal microbiota transplant or human antibody treatments, are available to combat rCDI under physician discretion. No treatments are commercially available that use a microbiome supplementation mechanism. Similar candidates are in preclinical studies, including mitochondrial therapeutics and bacterial consortiums, along with microbiota competitors that have reached Phase III clinical trials.
