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Overview

Technology

Summit has adopted a non-traditional approach to antibiotics: designing new mechanism antibiotics specifically for the pathogen or infection they address. This approach allows the unmet needs of patients and healthcare providers to be satisfied, with clear advantages over current broad-spectrum therapies.

The aim is to develop antibiotics for high-volume use, not to be held in reserve. This targeted approach supports antibiotic stewardship, improved outcomes for patients, and healthcare savings.

A current research target for Summit is CDI (C. difficile infection), an infection of the colon caused by the bacteria Clostridium difficile. It is characterized by severe diarrhea but can also result in serious disease complications, including bowel perforation, toxic megacolon, and sepsis. It can prove fatal in the most severe cases.

CDI is a serious issue in North America and Europe, with estimates of more than one million cases of CDI per year in these regions. The US Centers for Disease Control and Prevention (CDC) reports that CDI is responsible for 29,000 US deaths per year. The CDC has also designated CDI as one of three pathogens that pose an immediate public health threat and require urgent and aggressive action.

A healthy and diverse microbiome naturally protects against C. difficile colonization and infection. Patients who contract CDI typically have damaged microbiomes due to prior broad-spectrum antibiotic treatments for an unrelated infection. Initial treatment with the current standard of care antibiotic, vancomycin, fails to sustain cures in approximately one-third of cases due to further damage that vancomycin causes to patients’ microbiomes. The use of vancomycin leads to a high risk of recurrent disease. The risk of further recurrence rises to 65% after a patient suffers a second episode of CDI. Each recurrent episode of CDI is typically more severe than the prior episode and carries an increased risk of mortality. Reducing recurrent CDI is the key clinical issue.

Ridinilazole is a Phase 3, precision antibiotic in development by Summit for front-line CDI treatment to cure the initial infection and reduce disease recurrence. It is a new mechanism antibiotic, highly selective for C. difficile. It works to kill the bacteria by stopping cell division.

In Phase 2 clinical trial called CoDIFy, this selectivity allowed ridinilazole to outperform vancomycin by killing CDI while preserving patients’ microbiomes to reduce disease recurrence. Ridinilazole achieved statistical superiority over vancomycin in sustained clinical response (‘SCR’), which captures ridinilazole’s impact on both the initial treatment and disease recurrence.