The company noted that the drug has a ‘unique’ mechanism of action, differentiated from other therapeutics with similar indications, which could result in an alternative treatment option, given the increasing rates of antimicrobial resistance (AMR).
The Phase III clinical development project includes two studies, during which gepotidacin (GSK2140944) will be tested against infections caused by bacteria identified as antibiotic resistant threats by the US Centers for Disease Control and Prevention.
More specifically, during the first study, in which approximately 600 patients will participate, the candidate will be compared to therapy using ceftriaxone plus azithromycin. About 1,200 patients will take part in the second study, which will compare the candidate with nitrofurantoin, a licensed first-line antibiotic.
Hal Barron, GlaxoSmithKline’s CSO, commented that the candidate “has the potential to transform the treatment landscape” for patients with the diseases targeted by the product, with these being uncomplicated urinary tract infection and urogenital gonorrhea.
The company noted that the first results from the Phase III clinical trials are expected by the end of 2021.
A ‘new class’ of antibiotics
According to GSK, gepotidacin is the first drug to be developed among a ‘new class’ of antibiotics, which includes triazaacenaphthylene bacterial topoisomerase inhibitors.
Its mechanism of action is ‘distinct’ from any currently approved antibiotic, with the orally-administered candidate selectively interacting with two key bacterial enzymes, DNA gyrase and topoisomerase IV (type II topoisomerases), which are responsible for bacterial replication.
This confers activity against most target pathogens resistant to established antibiotics, the company stated.
A recent report by Clatham House highlighted the importance of combating AMR; however, the report noted that this effort is obstructed by the ‘lack of a firm commitment of monies’ from governments and pharmaceutical companies.