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Summit Corp’s (LON:SUMM) drug candidate for C. difficile infection has been accepted to a US initiative designed to speed up the development of new antibiotics.
The AIM-listed group’s SMT19969 has been designated by the Food & Drug Administration as a qualified infectious disease product under the Generating Antibiotics Incentives Now Act.
Practically, this means the treatment is eligible for priority review and fast track status.
And, if SMT19969 receives marketing approval from the FDA, it could receive a five-year extension of market exclusivity.
Chief executive Edwards told investors: "This status recognises the serious healthcare threat posed by pathogens such as C. difficile and it will confer a number of advantages that will accelerate the development of this promising and differentiated antibiotic with the potential to treat initial CDI and reduce the high rates of disease recurrence, the major clinical issue."
SMT 19969 is currently undergoing phase II clinical trials with results of the study due in the first half of next year.
C. difficile infection is established as a major healthcare threat, with around 900,000 cases per annum in Europe and North America.
Recurrent disease represents a key clinical issue with up to 30% of patients at risk of recurrent disease after the initial episode – and one it is hopes to tap into with 19969.
“This morning’s announcement is very positive particularly as QIDP status could extend the exclusivity period post launch of SMT19969,” said City broker N+1 Singer.
The group, which is valued at £56mln, is developing two key drugs – the antibiotic and another that it is hope will provide hope to the fatal muscle wasting disease, Duchenne Muscular Dystrophy.
At 1.40pm, the shares were changing hands for 137p each, down 2p.