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Summit receives US green light for phase II studies on C.diff drug

Last updated: 17:48 18 Mar 2014 AEDT, First published: 18:48 18 Mar 2014 AEDT

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Drug developer Summit (LON:SUMM) has been given the go ahead by American regulators to begin its phase-two, proof-of-concept study on a new-generation antibiotic for C. difficile infection (CDI).

The Food & Drug Administration clearance paves the way for trials to start later this half and triggers a £1.9mln milestone payment from the medical charity, the Wellcome Trust.

The cash forms part of what’s called a translational award that is being used to fund its drug candidate SMT19969.

Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with exceptionally high levels of antibacterial selectivity.

Chief executive Glyn Edwards added: "If this profile is replicated in future studies, SMT19969 could potentially offer a differentiated and more beneficial option to current CDI treatments, which continue to undermine the natural balance of the gut flora and lead to recurrent disease.

“We are excited about initiating a phase-two proof of concept clinical trial with the continued support of the Wellcome Trust."

The study, named CoDIFy, will be a double blind test, which means neither the patient nor the researchers will know who is receiving the drug until the results are collated.

A total of 100 patients with CDI will be recruited in the US and Canada.

Summit is also developing a potentially breakthrough treatment for the muscle wasting disease Duchenne Muscular Dystrophy.

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