A summary of our ongoing clinical trials can be found below
Clinical trials are a part of a carefully planned and legally required process to move from the identification of a potential new drug in the laboratory to market availability. Our ongoing clinical trials in infectious diseases are outlined below.
Ri-CoDIFy 1 and Ri-CoDIFy 2
Our global Phase 3 programme aims to differentiate ridinilazole from vancomycin, the current standard of care for CDI. These clinical trials are designed to help position ridinilazole for commercial success. The two planned Phase 3 clinical trials are expected to enrol approximately 680 patients each. The primary endpoint is testing for superiority in sustained clinical response (‘SCR’), which was achieved in our Phase 2 proof of concept trial, known as CoDIFy. Other endpoints include health economic outcome measures to support the commercial positioning of ridinilazole as a front-line treatment for CDI. These trials are partially supported by up to $62 million in funding from BARDA.