Summit Therapeutics plc announced that the European Patent Office (‘EPO') has granted a key patent covering the novel antibiotic, ridinilazole, and that the opposition period has expired with the patent having faced no challenge. The patent covers the use of ridinilazole for the treatment of infections caused by the bacterium Clostridium difficile. The patent (European patent number EP2373631) is entitled “Antibacterial Compounds” and will provide a period of exclusivity for the use of ridinilazole in the treatment of CDI through until December 1, 2029, with the possibility of patent term extension through to June 1, 2035 subject to the obtaining of Supplementary Protection Certificates and a paediatric investigation plan on marketing approval.

The patent has also been validated in all available contracting countries to the European Patent Convention, and so is now in force in over 30 European states including the United Kingdom, Germany, France, Spain, Italy, Switzerland and Norway. Patent protection has previously been granted for ridinilazole for the treatment of CDI in other countries including the United States, Australia, New Zealand, Japan, Russia and China, in addition to other territories. Ridinilazole is a novel class small molecule antibiotic that Summit is developing for the treatment of CDI.

Top-line results from a Phase 2 proof of concept trial reported in late 2015 showed that ridinilazole was statistically superior to vancomycin, the current standard of care, in the endpoint of sustained clinical response (‘SCR'). SCR was measured as cure at the end of treatment and no recurrence of CDI within 30 days of the end of treatment.