RECURRENT CLOSTRIDIUM DIFFICILE INFECTION

Full-Spectrum Microbiota™ platform has demonstrated promising results for preventing recurrent Clostridium difficile infection (CDI). CDI is a common bacterial infection causing patients to suffer from diarrhea, fever nausea, and abdominal pain. The Centers for Disease Control (CDC) has named CDI an urgent public health threat and the leading hospital-acquired infection in the U.S. Besides its enormous human toll, CDI drives significant costs due to extensive hospitalizations. Historically, standard-of-care antibiotic treatment presents a risk of recurrence in approximately 60% of patients who have experienced multiple recurrences, highlighting a clear unmet medical need. Patients who have already failed multiple rounds of antibiotics are especially susceptible to a recurrence of CDI as many of their beneficial bacteria have been eliminated. For more information on CDI, please visit the CDC website.

>700,000 patients infected per year

>29,000 deaths per year

$4.8B in excess health care costs

A 2014 proof-of-concept study led by Drs. Alexander Khoruts and Michael Sadowsky at the University of Minnesota developed a leading early-stage formulation of a Full-Spectrum Microbiota™ preparation.  The study demonstrated success in 43 of 49 patients with recurrent CDI (88% success rate), defined as no recurrence of CDI over two months.  Furthermore, patients’ microbial communities achieved near normalization within one month following treatment.

Khoruts et al. 2017

Finch’s lead, proprietary FSM™ candidate, CP101, is a capsule taken orally to deliver a healthy microbiota into a patient’s gastrointestinal tract to treat disease. CP101 is currently in a clinical trial, PRISM 3, for patients with recurrent CDI.

 

REFERENCES

Burden of Clostridium difficile infection in the United States. Lessa FC et al. N Engl J Med. 2015 Feb 26; 372(9): 825-34.

Clostridium difficile Infection. Leffler DA et al. N Engl J Med 2015; 372: 1539-1548.

Duodenal infusion of donor feces for recurrent Clostridium difficile. van Nood E et al. N Engl J Med. 2013 Jan 31; 368(5): 407-15.

Fecal microbiota transplant for recurrent Clostridium difficile infection: Mayo Clinic in Arizona experience. Patel NC et al. Mayo Clinic Proc 2013 Aug; 88(8): 799-805.

Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Drekonja D et al. Ann Intern Med 2015 May 5; 162(9): 630-8.

Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Kassam Z et al. Am J Gastroenterol. 2013 Apr; 108(4): 500-8.

The Long-term Efficacy and Safety of Fecal Microbiota Transplant for Recurrent, Severe, and Complicated Clostridium difficile Infection in 146 Elderly Individuals. Agrawal M et al. J Clin Gastroenterol. 2016 May-Jun; 50(5): 403-7.