Crestone Pharmaceuticals recently shared topline results from a phase 2 trial of its investigational drug treatment for Clostridioides difficile infection.
Investigators evaluated the safety and efficacy of CRS3123, a small-molecule protein synthesis inhibitor. They looked at two different dosages of the drug, 200 milligrams and 400 milligrams, which were administered twice-daily; the team compared those results with 125 milligrams of the antibiotic vancomycin given four times a day in adults who had C. difficile for the first time, or who had their first recurrence of the infection.
A total of 43 people were involved in the analysis. By day 12, 28 of 29 who received one dose of the study drug were cured by day 12. Similarly, 13 of 14 people who were given vancomycin were cured by day 12.
However, recurrence rates were notably lower among those taking the study drug. Just 4% of people who took CRS3123 had a recurrence by day 40, compared with 23% in the vancomycin group. CRS3121 was largely well-tolerated, with no serious adverse events.
An advantage of CRS3123 compared with other treatments is its narrow spectrum, which targets C. difficile bacteria and stops toxin production while minimally affecting other microbes in the gut. Vancomycin is considereed as a broad-spectrum antibiotic, which means that it commonly disrupts the gut microbiome.
There are about 500,000 cases of C. difficile each year; about one in six people with the infection will see it come back within two to eight weeks of the initial infection.
“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 of CDI,” Thomas Louie, MD, a lead study author and researcher from the University of Calgary, said in a press release. “The findings of this study support CRS3123 as such a candidate for further development.”
“It is now abundantly clear that curbing C. difficile while preserving healthy intestinal flora is what we want in a C. difficile infection therapeutic. The outcome of this phase 2 study further reinforces that goal,” Mark Wilcox, a professor at Leeds Teaching Hospitals and University of Leeds and lead on CDI for UK Health Security Agency, also said in the same statement.
