The bacterium Clostridioides difficile is one of the most common infections picked up in hospitals, and, even once it’s cleared from the body, patients have a 1 in 6 chance of catching it again within a couple of months. It also often resists antibiotic treatment, leaving it free to infect the colon and cause diarrhea, nausea, fever and, in severe cases, sepsis and death.
Boulder, Colorado-based biotech Crestone is going after C. diff with a new antimicrobial, CRS3123. In a phase 2 study, the company reports that its drug cured 28 of 29 patients within 12 days, similar to the 13 of 14 cured patients who received the antibiotic vancomycin.
But CRS3123 stood out by stopping C. diff’s notorious comebacks: After 40 days, just 4% of patients who received Crestone’s drug had their infections return, compared to 23% in the vancomycin group.
The cure rate at Day 12 was the trial’s primary endpoint. The study compared two twice-daily dosages of CRS3123, 200 mg and 400 mg, to 125 mg of vancomycin given four times a day in patients with an initial or first recurrence of C. diff infection.
It's critical for antibiotics to kill dangerous bacteria while leaving the healthy flora in our bodies alone. In fact, C. diff infections often spring up because the bacteria take advantage of a weakened microbiome following treatment with antibiotics for other diseases.
“Treatment of C. difficile infection remains in urgent need of agents that spare normal gut microbes, so they can reconstitute the microbiome and prevent further recurrences,” Thomas Louie, M.D., a microbiologist at the University of Calgary in Canada and leader of the study, said in the release. “The findings of this study support CRS3123 as such a candidate for further development.”
Following these top-line results, the National Institute of Allergy and Infectious Diseases is exercising an option in an existing contract with Crestone to grant the Coloradan company $4.5 million in new funding, according to the press release. This money will support microbiome analyses, optimization of manufacturing processes and other phase 2 support studies, the release said.