Recurrent Infections and Other Challenges of C difficile Prevention

The 9th Annual International C diff Conference & Health Expo is currently underway online. The first day of the conference concluded this afternoon, but Contagion highlighted some of the presentations from throughout the day.

Bioluminescense of C Difficile spores

High school juniors Emma Brashear and Layla Ouldnouri have been researching C difficile infection (CDI) for over 2 years, and identified its invisible spores as one of the greatest challenges in preventing CDI.

Their solution was a wipe that makes C diff spores visible under ultraviolet light and thus easier to clean. Germinating C diff spores release the chemical compound dipicolinic acid, which illuminates under UV light when combined with terbium chloride.

The presenters highlighted the importance of their research, as C diff infections cost $8.2 billion a year and cause more deaths each year than drunk driving and HIV combined.

"Microbiome Therapeutics in 2021: Almost there for C difficile!"

Sahil Khanna, MD, Professor of Medicine in the Mayo Clinic Division of Gastroenterology and Hepatology gave this presentation. He described recurring C difficile infections (CDI) as one of the greatest problems in modern medicine.

Khanna called microbiota restoration the “holy grail” for managing recurrent, and cited it as being over 85% effective at treating recurrent CDI. Additionally, microbiota restoration is superior to oral vancomycin and has fewer recipient contraindications.

Fecal Microbial Transplant (FMT) is also safe and effective for recurrent CDI. FMT practices are heterogeneous, though donor FMT is superior to autologous FMT.

When treating CDI, Khanna also advocated for eliminating modifiable risk factors, such as PPIs, hospitalization, sick contacts, and antibiotics.

Khanna called standardized microbiota restoration “the future,” citing positive data from RBX2660 phase 3, SER-109 phase 3, CP101 phase 2, RBX7455 phase 2, and VE303 phase 2.

Introduction to Microbiota and Microbiota Restoration for Recurrent C Diff Infections

Presented by Ken Blount, Chief Scientific Officer of Rebiotix, this research also focused on recurrent CDI. Blount detailed the various ways each person’s complex and diverse community of microbes influence health.

Antibiotics disrupt a person’s normal bacterial microbiome, leading to CDI and recurrent CDI. The goal of investigational live biotherapeutics is to restore healthy microbiota and reduce recurrent CDI.

Blount cited RBX2660 and RBX7455, the same clinical trials as Khanna, as evidence of restoring microbiota and metabolite compositions to fight CDI.

CP101, an Investigational Orally Administered Microbiome Therapeutic Designed to Prevent Recurrent CDI

The final presentation of the first day of the conference was given by Shrish Bedree, MD, PhD, Medical Director and Head of Clinical Microbiome Science at Finch Therapeutics.

Bedree highlighted that recurrent CDI is an unmet medical need, and a significant burden on the healthcare system, noting that Finch is the only company with complete and targeted approaches for developing microbiome therapeutics.

CP101 is an orally administered investigational microbiome therapeutic that offers a complete microbial community. One administration of CP101 resulted in a rapid and sustained increase of microbiome diversity in Finch’s PRISM3 trial.

CP101 met its primary efficacy endpoint in PRISM3, and demonstrated statistically significant prevention of recurrent CDI. By week 8, CP101 achieved 33.8% relative risk reduction for CDI recurrence. There were no treatment-related serious adverse events reported for the CP101 arm.