After constructive negotiations with several regulators including the US Food and Drug Administration and European Medicines Agency, Summit said it will design a trial intended at assessing the superiority of ridinilazole over the current standard of care C. diff treatment.
The UK pharma stated that positive result from the phase 3 programme could pave way for the commercial launch of ridinilazole as a differentiated therapy for treating initial CDI and also in reduction of disease recurrence.
Summit CEO Glyn Edwards said: “The constructive end of Phase 2 meetings with the US and European regulators have enabled us to design a Phase 3 programme that focuses on evaluating ridinilazole’s superiority over standard of care.
“This is something we believe would help differentiate our novel class antibiotic from currently marketed CDI treatments and those in late-stage development. Superiority in the combined measure of treatment of initial infection and importantly, reduction in recurrence, could position ridinilazole for front-line treatment of CDI.”
The company intends to have two trials in the phase 3 programme with one assessing it against standard of care, and the other against vancomycin. Both the trials will enroll nearly 700 CDI patients while the primary endpoint defined to be superiority in sustained clinical response (‘SCR’).
Other endpoints planned for the two phase 3 trials will feature health economic outcome measures.
The launch of the phase 3 programs comes after Summit’s successful phase 2 trial dubbed CoDIFy which proved that ridinilazole reached statistical superiority compared to vancomycin in SCR.
Ridinilazole has been confirmed by the FDA for its eligibility for Priority Review based on its Qualified Infectious Disease Product (QDIP) designation.