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Patient-friendly new era standard of care for infectious disease

"It's well known that broad-spectrum antibiotics are coming to the end of their days. Summit is developing the next generation approach."

Bob Duggan

Chief Executive Officer

Overview

Anti-Microbial

Summit Therapeutics is a leader in antibiotic innovation, with a strategy to create a new standard of care for serious infectious diseases.

The last new mechanism antibiotic to be approved by the FDA was in 2003. No new classes have been approved since. Most existing antibiotics are broad-spectrum: they inhibit or kill a wide range of bacteria, whether they are dangerous or not, which leads to the development of resistant strains. Their overuse is creating an era of untreatable infections. Even infections that were once easily curable could become global health crises.

Summit has a highly promising pipeline of new candidates for narrow-spectrum antibiotics. They target specific unwanted bacteria, leaving healthy bacteria alone. The result is medicines that are far less prone to creating resistant strains of undesirable bacteria, and that place far less stress on the patient’s normal, healthy immune responses.

A vital tool in Summit’s development is its Discuva Platform that helps in the discovery of these new mechanism antibiotics. It uncovers novel bacterial targets and develops new mechanism antibiotics against them.

To date, the Discuva Platform has developed two new targets for gonorrhea, an ESKAPE (an acronym encompassing the names of six bacterial pathogens commonly associated with anti-microbial resistance) program, and undisclosed programs with Roche (a pharmaceutical company based in Switzerland).

In addition, ridinilazole, Summit’s new mechanism antibiotic for C. difficile infection, is being supported by an award worth up to $63.7 million from the US government’s Biomedical Advanced Research and Development Authority (BARDA). It is now progressing in Phase 3 trials.

Bob Duggan became the CEO of Summit Therapeutics in 2020 and is enthusiastic about its commitment to solutions.

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.

Key Dates

Summit appoints Robert W. Duggan as Chief Executive Officer

14 Apr 2020

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Summit Therapeutics gets US$50mln backing from biotech billionaire Bob Duggan

06 Dec 2019

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Narrow-spectrum antibiotic treatment of Clostridium difficile infection improves preservation of intestinal metabolic profile

07 Oct 2019

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Effect of broad vs. narrow-spectrum Clostridioides difficile treatment on human stool bile acid composition over time

07 Oct 2019

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Quality of Life Changes in Patients with Clostridium difficile Infection (CDI): A Randomized, Double-Blind Trial of Ridinilazole (RDZ) Compared to Vancomycin (VAN)

03 Oct 2019

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Combating resistance while maintaining innovation: the future of anti-microbial stewardship

18 Sep 2019

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Robert Duggan invests $25mn into Summit

17 Dec 2018

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Summit Therapeutics was founded

01 Jan 2003

Media

Summit Therapeutics announces £38M fundraising success

02 Jan 2020

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Summit Therapeutics’ Glyn Edwards talks US$50mln backing and ridinilazole progress

09 Dec 2019

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Billionaire’s big investment shows renewed faith in drugs company

07 Dec 2019

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Biotech Firms Fight Panic Over Spread of Superbugs

08 Nov 2019

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"Certainly a resident tendency to expect the best possible outcome fuels the energy always required to make a meaningful difference for the betterment of existing conditions.”

Bob Duggan

Chief Executive Officer

Key Dates

Summit appoints Robert W. Duggan as Chief Executive Officer

14 Apr 2020

Summit Therapeutics gets US$50mln backing from biotech billionaire Bob Duggan

06 Dec 2019

Narrow-spectrum antibiotic treatment of Clostridium difficile infection improves preservation of intestinal metabolic profile

07 Oct 2019

Effect of broad vs. narrow-spectrum Clostridioides difficile treatment on human stool bile acid composition over time

07 Oct 2019

Quality of Life Changes in Patients with Clostridium difficile Infection (CDI): A Randomized, Double-Blind Trial of Ridinilazole (RDZ) Compared to Vancomycin (VAN)

03 Oct 2019

Combating resistance while maintaining innovation: the future of anti-microbial stewardship

18 Sep 2019

Robert Duggan invests $25mn into Summit

17 Dec 2018

Summit Therapeutics was founded

01 Jan 2003

Media

Summit Therapeutics announces £38M fundraising success

02 Jan 2020

Summit Therapeutics’ Glyn Edwards talks US$50mln backing and ridinilazole progress

09 Dec 2019

Billionaire’s big investment shows renewed faith in drugs company

07 Dec 2019

Biotech Firms Fight Panic Over Spread of Superbugs

08 Nov 2019