Background: Antibiotics targeted against C. difficile bacteria are necessary, but insufficient, to achieve a durable clinical response because they have no effect on C. difficile spores that germinate within a disrupted microbiome. ECOSPOR-III evaluated SER-109, an investigational, biologically-derived microbiome therapeutic of purified Firmicute spores for treatment of recurrent CDI. Methods: Adults ≥18 years with recurrent [...]

Background: Microbiota-based treatments have shown promise to reduce recurrence for recurrent Clostridioides difficile infections (rCDI), but consistent and reliable safety data are needed to support regulatory approvals and broaden patient access. Here we provide cumulative safety data from 5 prospective clinical studies evaluating RBX2660—a standardized, microbiota-based investigational live biotherapeutic—for reducing rCDI. Methods: This analysis included [...]

Background: Recurrent Clostridioides difficile infection (rCDI) is an urgent public health threat. RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic that has been evaluated in 5 prospective clinical trials. Eligibility criteria in clinical trials are often narrowly defined, excluding broader patient populations. Herein, we report a retrospective analysis of safety and efficacy of RBX2660 [...]

Background: Antibiotics used to treat Clostridioides difficile infection (CDI) can predispose patients to recurrent CDI (rCDI). Gut microbiome restoration by fecal microbiota transplantation is recommended by multiple guidelines after ≥2 episodes of rCDI, with no guideline-recommended options to restore the microbiome earlier in the course of CDI. RBX2660 is a standardized, microbiota-based live biotherapeutic being [...]

Background: Clostridioides difficile is an opportunistic pathogen that causes an estimated 500,000 infections per year in the United States. RBX2660, a standardized, microbiota-based live biotherapeutic, is being investigated as a treatment option for recurrent C. difficile infection (rCDI). RBX2660 has demonstrated consistent tolerability and efficacy in reducing rCDI across 6 clinical studies. We present a [...]

Background: Clostridioides difficile infection (CDI) is a leading healthcare-associated infection causing debilitating diarrhea, life-threatening complications, 20,500 deaths and healthcare costs of up to $5.4 billion annually in the US. The main driver of CDI costs is hospitalizations, and patients with higher CDI recurrence rates have more hospitalizations and emergency department visits and longer hospital stays. [...]

Background: Antibiotics targeted against C. difficile bacteria are necessary, but insufficient, to achieve a durable clinical response because they have no effect on C. difficile spores that germinate within a disrupted microbiome. ECOSPOR-III evaluated SER-109, an investigational, biologically-derived microbiome therapeutic of purified Firmicute spores for treatment of recurrent CDI. Methods: Adults ≥18 years with recurrent [...]