Positive results with new oral microbiome drug for C. diff
Finch Therapeutics announced positive topline results from a randomized controlled trial of CP101 for the prevention of recurrent Clostridioides difficile infection, according to a press release.
In PRISM3, a multicenter, randomized, double-blind, placebo-controlled phase 2 trial, researchers assessed the investigational oral microbiome drug CP101 in 206 patients with recurrent C. difficle at 51 sites across the United States and Canada.
“It is really exciting and will change the microbiome field going forward,” Jessica Allegretti, MD, MPH, principal investigator in the PRISM3 clinical trial at Brigham and Women’s hospital in Boston, told Healio Gastroenterology. “CP101 did meet the primary efficacy endpoint of sustained clinical cure among 74.5% of the patients with recurrent C. difficile who received a single administration of CP101. Recurrent C. difficile can really devastate patient’s lives so to have an oral drug candidate like this represents a pivotal moment for the improvement in care of these patients.
By comparison, 61.5% of control patients who received standard-of-care antibiotic therapy alone met the primary efficacy endpoint (P < .05). According to the release, CP101 was well-tolerated with no serious adverse events related to the treatment. Investigators will follow the patients for another 16 weeks for additional safety and efficacy endpoints.
Finch Therapeutics also announced the initiation of a program that will assess the use of CP101 for the treatment of chronic hepatitis B to see if CP101 may restore the microbiome and support activation of an immune response.
“This is just the tip of the iceberg for the field,” Zain Kassam, MD, MPH, chief medical officer at Finch, told Healio Gastroenterology. “We are excited to apply CP101 to C. difficle and a number of other microbiome-mediated medical conditions. We are launching a program in chronic hepatitis B. There are exciting preliminary studies not just in gastrointestinal and infectious diseases, but in conditions beyond the GI tract including the liver, neurodevelopment and immune conditions. We are excited to work with the FDA to make this potentially new class of oral medicine accessible to patients as soon as we can.”