1st Feb 2017 12:15
LONDON (Alliance News) - Summit Therapeutics PLC on Wednesday detailed its phase III programme for its antibiotic ridinilazole after meetings with regulators in the US and Europe.
Shares in Summit were up 20% at 204.00 pence Wednesday, shortly after midday.
With input from the US Food & Drug Administration and the European Medicines Agency, Summit plans to design a phase III clinical programme to evaluate the antibiotic's superiority over standard of care in the treatment of Clostridium difficile infection.
A positive result from this programme would potentially support a commercial launch of ridinilazole, Summit said.
This programme is expected to include two trials, with designs consistent with its successful proof of concept phase II trial.
"As we continue to evaluate our options to maximise the value of ridinilazole, our stronger financial position following the DMD programme partnership with Sarepta Therapeutics, Inc means Summit has more time to fully explore all options. These include potentially entering into a collaboration with a third party or securing meaningful non-dilutive funding from government and charitable organisations. In parallel, activities to prepare ridinilazole for Phase 3 trials continue with these anticipated to start in the first half of 2018.," said Chief Executive Officer Glyn Edwards in a statement.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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