Microbial therapies developer Finch Therapeutics has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational CP101 drug to treat recurrent Clostridium difficile (C. difficile) infection.

CP101 is an oral, full-spectrum microbiota product. It is designed to contain the full complement of functional microorganisms, delivering bacteria to the patient’s intestine to potentially restore healthy microbiome.

The drug is intended to prevent recurrent C. difficile bacterial infection.

Finch is currently evaluating the investigational drug in the Phase II PRISM3 clinical trial involving around 200 participants aged 18 years or above at clinical centres across the US.

The randomised, placebo-controlled trial is assessing the safety, efficacy and tolerability of CP101 as a single dose oral capsule in preventing recurrence of C. difficile.

Primary outcome measures of the study are the proportion of patients without recurrence of symptomatic, laboratory-confirmed C. difficile infection and those with adverse events.

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By GlobalData
“This designation will accelerate our efforts to provide an effective therapy for patients living with this devastating infection.”

The trial will also monitor secondary outcome measures such as sustained clinical cure of infection by C. difficile subtype and time to first recurrent infection episode.

Finch Therapeutics CEO Mark Smith said: “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. difficile.

“This designation will accelerate our efforts to provide an effective therapy for patients living with this devastating infection, and we look forward to working closely with the FDA to advance that mission.”

C. difficile infection is known to affect more than 500,000 patients and is responsible for approximately 29,000 deaths each year.

The Centers for Disease Control (CDC) classified recurrence of the infection as an urgent public health threat.

Finch added that a high percentage of patients are failing standard-of-care antibiotic therapy, indicating an urgent unmet medical need.