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Ridinilazole

Ridinilazole (SMT19969) is a non-absorbable small molecule antibiotic for oral administration to treat Clostridium difficile infection (CDI).

its mechanism of action "remains to be fully determined".

In preclinical studies, ridinilazole showed a potent bactericidal effect against all strains of C. difficile tested.

In a Phase 2 proof of concept trial in CDI patients (‘CoDIFy’), ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. SCR rates were 66.7% for ridinilazole compared to 42.4% for vancomycin.

Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track status by the US FDA.