Summit Therapeutics plc (NASDAQ:SMMT) Q2 2019 Earnings Conference Call - Final Transcript
Oct 11, 2019 • 08:00 am ET
play a really major role in our health. Broad spectrum antibiotics another non-antibiotic medicines can upset the delicate and diverse mechanism of these microbiomes and this can have long lasting effects on human health, is therefore particularly advantageous to specifically target the bad bacteria and spare the microbiomes. The impact of the microbiome on health and disease is extremely evidence in C. difficile infection or CDI.
The onset of CDI is often linked to a perturbed gut microbiome and further disruption by the broad spectrum antibiotics used to as standard of care is tied to a high recurrence rate. Now, ridinilazole is designed to selectively kill C. difficile. The effect is shown in our phase 2 clinical trial, is that the natural gut microbiome can protect against CDI recurrence and in the phase 2 clinical trial, ridinilazole showed a 60% reduction in recurrences and superiority over the current standard of care in sustaining cures.
The last change in the antibiotic field that I'll discuss is the emergence of antibiotic resistance and the implementation of antibiotic stewardship programs in hospitals as a result. Stewardship calls for the use of the right drug for the right patient at the right time and in the right dose. The more targeted an antibiotic is for that bacteria is meant to kill, the less collateral damage it inflicts. Broad spectrum antibiotics may be specifically dose for a certain pathogen, but this could be sub-optimal for another pathogen and sub-optimal dosing is one of the factors that creates resistance.
Ridinilazole is aligned with good stewardship as it's an antibiotic specific for C. difficile with minimal impact on other bacteria. Ridinilazole is designed to improve patient outcomes in CDI and is currently being evaluated in a global phase 3 clinical trial, called Ri-CoDIFy. These landmark design trials have three features, a superiority endpoint, inclusion of health economic measures and deep, deep microbiome analysis as we seek to position ridinilazole as the frontline treatment for CDI.
We aim to achieve superiority in sustained clinical response in our phase 3 trials. To achieve this endpoint, a patient must be cured at the end of 10 days of treatment and remain cured so not having a recurrence in the following 30 days. It is a measure where vancomycin is failing in about a third of patients and where we have seen positive impact of ridinilazole in our phase 2 clinical trial. The trials were initiated in February 2019. They're also designed to show the economic value of treating patients with ridinilazole in CDI. And this is done through various health economic measures including length of hospital stay and readmission rates. CDI is expensive to treat and these patients are often isolated and have longer hospital stays on average, than those with other diseases.
And in addition, those with recurrent episodes of CDI are typically sicker with increased morbidity and mortality and if ridinilazole can get patients out of the hospital sooner and also prevent readmissions, we will have the economic