Recruitment is expected to take around two years, with the first results coming back in early 2022, give or take a few months.
Previous studies have shown that the precision antibiotic can target C. Diff bacteria without also damaging the natural gut flora. It has also been shown to be better than the current gold standard, vancomycin.
Getting ridinilazole into and through phase III trials will be Summit’s primary focus now after the disappointment of its Duchenne muscular dystrophy candidate, ezutromid, this summer.
Interim data for ezutromid published in January was encouraging, but the benefits seen then weren’t sustained for the remainder of the trial.
The data forced Summit to make the “difficult decision” to discontinue the development of the drug, with the company, instead, switching focus to its growing portfolio of antibiotics candidates.
“The world is in desperate need of new antibiotics, and we believe we can deliver with our new mechanism antibiotics covering the most urgent infectious disease threats and a platform that has the potential to continue to unveil novel targets and deliver optimised candidates for the clinic,” said chief executive Glyn Edwards.
With the DMD drug coming up short, Summit has reinvented itself to become an antibiotics specialist, with ridinilazole at the forefront.
The sector is commanding a lot of attention and investment at the moment, with the World Health Organization recently declaring that antibiotic resistance is “one of the biggest threats to global health”.
Adding weight to that is the government’s estimate that 5,000 people die every year in the UK because antibiotics no longer work for some infections.
Using its Discuva platform, Summit has identified a potential treatment for gonorrhoea – a sexually transmitted infection which affects an estimated 78mln people every year.
Because it is quite common, the bacteria are becoming more and resistant to traditional treatments, which is making it harder to treat.
Summit’s compound – SMT-571 – is set to enter a phase I clinical trial in the second half of 2019 and the study will be supported by the US$4.5mln it received from CARB-X, a US programme designed to accelerate the development of new antibiotics.
The Discuva platform has also yielded “multiple” potential ways to kill hospital-acquired superbugs such as MRSA.
Summit said it has been able to identify genes which are essential for such pathogens to survive, information which it is using to try to develop new drug candidates.
Summit recorded a profit of £26.6mln in the three months ended July 31, compared to a loss of £3.3mln a year earlier.
The swing to a profit was brought about by the recognition of all deferred revenue related to the Sarepta licence and collaboration agreement following the discontinuation of ezutromid.
At the end of July, Summit had just shy of £17.1mln in the bank, having raised £15mln from investors back in March.
With a raft of cost measures brought in in the wake of the ezutromid disappointment, the company reckons that should be enough to last it until the end of next September.
Summit shares rose 5.4% to 35.3p on Thursday afternoon.