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Gut Microbe Drug Shown to Prevent Return Infections

C. difficile in petri dish

C. difficile bacteria in petri dish (CDC.gov)

19 June 2020. Early results from a clinical trial show an oral drug taken one time prevents more recurring infections from harmful gut bacteria than conventional treatments. The drug code-named CP101 by Finch Therapeutics Group Inc. in Somerville, Massachusetts, is being tested in patients with Clostridium difficile, or C. difficile, infections.

C. difficile infections are often contracted in health care facilities, such as clinics and hospitals, causing inflammation in the colon, and symptoms including watery diarrhea, abdominal pain, nausea, loss of appetite, and fever. People who have other illnesses or conditions requiring prolonged use of antibiotics, and the elderly, are at greater risk of this disease. According to Centers for Disease Control and Prevention, almost 224,000 C. difficile infections occurred in the U.S. in 2017, leading to 12,800 deaths.

Finch Therapeutics is a biotechnology company developing treatments for diseases linked to the gastrointestinal tract, particularly the natural community of bacteria and other microbes in the gut known as the microbiome. The company designs treatments for gut-related disorders from healthy human stool donations that it screens and produces as oral drugs. Finch also develops therapies from microbial strains grown in its lab to act on specific targets in the gut. The company’s pipeline includes diseases affecting the gut, such as C. difficile and ulcerative colitis, but also hepatitis B.

CP101 is Finch Therapeutics’ lead product, derived from donated stool bacteria and taken as an oral capsule to prevent recurring C. difficile infections. The drug, according to the company, acts by restoring the gut’s natural resistance to colonizing harmful pathogens, such as C. difficile. In February 2019, FDA designated CP101 as a breakthrough therapy, qualifying the drug for expedited review by the agency. The company is also developing CP101 as a treatment for hepatitis B, still in preclinical stages.

The clinical trial testing CP101 is a mid-stage study, enrolling 206 adults with recurring C. difficile infections at 51 sites. Participants are randomly assigned to receive one dose of either CP101 or a placebo with standard antibiotics, then evaluated after eight and 24 weeks. The study team, led by gastroenterologist Jessica Allegretti at Brigham and Women’s Hospital in Boston, is looking primarily for any recurrence of C. difficile infections, as well as adverse effects from the drug after eight weeks.

The company released overall results of the trial — not in a peer-reviewed publication — showing three in four (75%) of CP101 recipients report no further C. difficile infections, or CDIs, after eight weeks, compared to about six in 10 (62%) of placebo recipients, a large enough difference for statistical reliability. In addition, says Finch, CP101 is well-tolerated with no treatment-related serious adverse events.

In a company statement, Allegretti says the results, “show that CP101 has the potential to fulfill the need for an oral drug that breaks the cycle of CDI recurrence, preventing the devastating effects of recurrent C. difficile infections on patients’ lives.” She adds, “This validates the approach of microbiome restoration and is a critical milestone for the field, opening the potential to develop this class of therapy for many other conditions arising from disruption of the microbiome.”

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