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.