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 program 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 Phase 3 clinical trials are expected to enroll 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 measures include health economic outcomes to support the commercial positioning of ridinilazole as a front-line treatment for CDI. These trials are partially supported by up to $72.5 million in funding from BARDA.
For more information, visit www.ricodifytrial.com.
Our Phase 3 program includes an additional study to determine the safety of ridinilazole as compared to vancomycin, the current standard of care for CDI, in adolescents 12 through 17 years of age. The trial is expected to enroll approximately 40 patients.
For more information, visit www.ricodifycdiff.com.