FDA Grants Breakthrough Therapy Designation for Investigational Drug for Recurrent C Diff Infection

The US Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation to investigational drug CP101 for the treatment of recurrent C diff infection, Finch Therapeutics announced today.

The drug is being developed to address an unmet need in C diff prevention. Recurrent C diff has been designated an urgent public health threat by the US Centers for Disease Control and Prevention due to the high percentage of patients failing standard-of-care treatment.

“CP101 is designed to break the cycles of infection by restoring the balance of the gut microbiome, an approach supported by numerous clinical studies and Finch’s extensive experience providing microbial treatments to patients suffering from [C diff,]” Mark Smith, chief executive officer of Finch said in making the announcement.

The company reports that participants are currently being enrolled into a randomized, placebo-controlled phase 2 clinical trial called PRISM3. The trial will assess the safety and efficacy of the drug, which will be administered in a single dose through an oral capsule.

“The investigational treatment, CP101, is a capsule containing a freeze-dried community of bacteria from a healthy human gut,” the company website explains. “It is designed to deliver this new microbiome to the specific areas of the intestine that have been disrupted by C diff and antibiotics.”

Participants who enroll in the study will be assigned at random to receive the investigational drug or a placebo. Over a 6-month period the participants will meet with clinical staff 7 times to have their health and progress evaluated. Participants will also submit stool samples throughout the study using at-home collection kits.

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.