Clinical trial to prevent recurrent C. difficile infection underway
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Patients have begun enrolling into Crestovo’s PRISM 3 clinical trial to evaluate their orally administered microbiome therapy CP101 for the prevention of recurrent Clostridium difficile infection, according to a press release.
PRISM 3 will build on the success of a clinical trial that involved Alexander Khoruts, MD, professor of medicine in the division of gastroenterology, hepatology and nutrition at University of Minnesota, who helped developed a leading early-stage oral formulation of a microbiota-based product in 2014. Khoruts and colleagues administered their product to about 50 patients with recurrent CDI, and found that 88% of patients had no recurrence of CDI over two months.
This randomized, placebo-controlled trial to assess the efficacy and safety of CP101 in patients with recurrent CDI, aims to prevent the recurrence of CDI through 8 weeks following administration of CP101, vs. placebo. CP101, generated from Crestovo’s Full-Spectrum Microbiota platform, contains the full complement of functional microorganisms that may help fix microbial imbalance. Crestovo expects to report top-line data in 2018.
“There is a critical, unmet medical need for new treatments for recurrent CDI in the U.S., with antibiotics often further exacerbating the problem of dysbiosis in such patients,” Thomas Borody, MD, a scientific founder of Crestovo, said in the release. “Unlike other therapies in development across the industry, CP101 combines the ease of oral administration with the potential clinical benefits of a full-spectrum microbiota composition.”
Disclosure: Borody is a founder of Crestovo.