Ridinilazole, Summit’s lead candidate, is due to enter phase III trials in the first quarter of 2019.
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 DMD candidate, ezutromid.
It was only in January when the market was getting excited about the prospects for ezutromid following encouraging interim data from the PhaseOut study.
Back then, the firm said ezutromid had had a “statistically significant and meaningful” effect in reducing muscle damage in patients.
But the benefits seen at the half-way stage weren’t sustained for the remainder of the trial, forcing Summit to make the “difficult decision” to discontinue the development of the drug.
“While we believe utrophin modulation could still have a place in the treatment of DMD, it is clear that ezutromid is not providing a benefit for patients,” said chief executive Glyn Edwards.
“We therefore feel that our resources are better focussed on the development of our promising pipeline of new mechanism antibiotics.”
Summit has more to its game than just ezutromid and ridinilazole.
Using its Discuva drug discovery platform, the company has identified two possible compounds 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.
In early testing, Summit’s two antibiotic compounds have shown high potency against gonorrhoea bacteria with no development of resistance so far.
The company has high hopes for the series of compounds and reckons they have the potential to produce a new front-line therapy for gonorrhoea.
The aim is to select a candidate from the lead series of compounds for progression into IND-enabling (investigational new drug) studies in the second half of 2018. Assuming the IND application is cleared, the treatment will then make its way into the clinic.
Strong cash position
At the end of April, Summit had just shy of £28mln in the bank, having raised £15mln from investors back in March.
At the time, the company said that would last it until next spring. Given that it is bringing in cost reduction measures in the wake of the DMD disappointment, management said in a conference call that it could last even longer, although it is reluctant to put an exact date on it.