Crestone's antibiotic outperforms vancomycin for C. diff in phase 2

Clostridioides difficile infections frequently emerge due to the bacterium exploiting a compromised microbiome after antibiotic treatment for other illnesses. The bacterium Clostridioides difficile is a prevalent infection in hospital settings, and once contracted, there is a significant chance of recurrence. Patients face a 1 in 6 likelihood of reinfection within a few months even after initial clearance. This bacterium is also known for its resistance to antibiotic treatments, which allows it to infect the colon and cause symptoms such as diarrhea, nausea, fever, and in severe cases, sepsis and death.

Crestone, a biotech company based in Boulder, Colorado, is targeting C. difficile with a novel antimicrobial drug named CRS3123. In a phase 2 clinical trial, Crestone reported that CRS3123 successfully cured 28 out of 29 patients within 12 days. This cure rate is comparable to the 13 out of 14 patients cured with the antibiotic vancomycin. However, CRS3123 distinguished itself by markedly reducing the recurrence of C. difficile infections. After 40 days, only 4% of patients treated with CRS3123 experienced a return of their infection, in contrast to 23% in the vancomycin group.

The primary endpoint of the trial was the cure rate at Day 12. The study evaluated two dosages of CRS3123, 200 mg and 400 mg, administered twice daily, against 125 mg of vancomycin given four times daily to patients with an initial or first recurrence of a C. difficile infection.

It is crucial for antibiotics to eradicate harmful bacteria while preserving the beneficial flora in the body. C. difficile infections frequently arise when the microbiome is weakened by antibiotics used to treat other diseases. According to Thomas Louie, M.D., a microbiologist at the University of Calgary and leader of the study, there is an urgent need for treatments that protect normal gut microbes, allowing the microbiome to reconstitute and prevent further recurrences. Dr. Louie stated that the study's findings support the continued development of CRS3123 as a potential treatment.

Following these promising top-line results, the National Institute of Allergy and Infectious Diseases has decided to exercise an option in an existing contract with Crestone. This will provide the Colorado-based company with $4.5 million in new funding. According to the press release, these funds will be used to support microbiome analyses, optimize manufacturing processes, and conduct other phase 2 support studies.

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