Ridinilazole is a new mechanism antibiotic. It is highly selective for C. difficile and works to kill the bacteria by stopping cell division.
In a Phase 2 clinical trial called CoDIFy, this selectivity allowed ridinilazole to outperform vancomycin by killing C. difficile 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.
Ridinilazole has been generally well tolerated in Phase 1 and 2 clinical trials.
With these positive results, we are advancing ridinilazole to Phase 3 clinical trials to support the right label for treating CDI and reducing recurrences. To do so, we have designed the Phase 3 trials to test for superiority over the standard of care, vancomycin, in SCR, which was achieved in CoDIFy. Further, we are gathering health economic outcomes data that we believe will be important to support the commercialisation of ridinilazole, if approved. The Phase 3 clinical trials are expected to begin in the first quarter of 2019.