Investigational Therapy for CDI has Positive Results

Somerville, MA-based Finch Therapeutics Group announced positive results for its investigational oral microbiome drug, CP101, from its PRISM3 trial. CP101 was developed for the prevention of recurrent C. difficile infection (CDI).

PRISM3, is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial. The trial used 206 randomized patients with recurrent CDI at 51 sites across the US and Canada.

The drug met the primary efficacy endpoint in PRISM3, with 74.5% of recurrent CDI patients who received a single administration of CP101 achieving a sustained clinical cure through week 8. This was a statistically significant improvement in comparison to 61.5% of patients in the control group who received standard-of-care antibiotic therapy alone (p < 0.05).

"These results are very encouraging and show that CP101 has the potential to fulfill the need for an oral drug that breaks the cycle of CDI recurrence, preventing the devastating effects of recurrent C. difficile infections on patients’ lives,” Jessica Allegretti, MD, MPH, principal investigator in the PRISM3 clinical trial said. “This validates the approach of microbiome restoration and is a critical milestone for the field, opening the potential to develop this class of therapy for many other conditions arising from disruption of the microbiome.”

After patients achieved a sustained clinical cure, they are being followed for 16 weeks for additional safety and efficacy endpoints.

The US Food and Drug Administration (FDA) granted CP101 a Breakthrough Therapy Designation in February of 2019. The Breakthrough Therapy Designation is intended to expedite the development and review of investigational therapeutics for areas of unmet need when preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies.

In addition, Finch announced its plans to evaluate CP101 for the chronic hepatitis B treatment. There is clinical evidence that demonstrates hepatitis B virus e-antigen clearance following microbiome restoration, even among patients that have failed to achieve clearance following long-term antiviral therapy.

The company intends to study if CP101 may restore the microbiome and support activation of an immune response in chronic hepatitis B patients.

“We plan to apply the same principles we used in CDI against the many other conditions linked to microbiome dysfunction,” Finch CEO Mark Smith said in an announcement. “As an important next step towards this vision, we are announcing today a new development program for CP101 in the treatment of chronic hepatitis B.”