- GlaxoSmithKline has begun two late-stage studies of a potentially first-in-its-class antibiotic, a milestone that's become less common as larger drugmakers abandon research into new antibacterial treatments.
- Gepotidacin, as the experimental drug is known, was first developed by GSK in 2007, and has advanced with the support of a public-private partnership established in 2013 between GSK, the Biomedical Advanced Research and Development Authority (BARDA) and the Defense Threat Reduction Agency (DTRA).
- GSK is testing gepotidacin for use against uncomplicated urinary tract infections and urogenital gonorrhea, two common infections caused by bacteria recognized as antibiotic resistant. First results from the clinical program are expected by the end of 2021, the British pharma said in a statement Monday.
GSK is one of the few big pharmas still researching vaccines and antibiotics, both therapeutic markets that have taken a backseat to other drug development areas like oncology and rare disease.
Traditional drug payment models, based on volume sold, have largely failed to support development of novel antibiotics — use of which is often limited in efforts by health authorities and physicians to prevent antimicrobial resistance.
Such difficulties were on display this year with the bankruptcy of Achaogen, a biotech that won Food and Drug Administration approval for its antibiotic, Zemdri (plazomicin). Earlier this year, Zemdri was added to the World Health Organization's essential medicines lists, even as Achaogen failed to establish a meaningful commercial market for the treatment.
GSK has already taken steps to give gepotidacin a better shot at commercial success. The pharma has worked with the U.K. government to establish a subscription model that ties payment to access to the drug instead of the volume used.
"There is no greater threat to global health than drug-resistant infections, yet there have been no major new antibiotic drug classes discovered since the 1980s," Matt Hancock, the U.K.'s health and social care secretary, said in a July 9 statement about the new payment model.
In its 2018 annual report, GSK said it has submitted gepotidacin to that U.K reimbursement program.
The clinical program is also partially funded by the U.S. government through BARDA and DTRA.
The first study, called EAGLE-1, will test gepotidacin against ceftriaxone plus azithromycin in approximately 600 patients with gonorrhea. The second trial, EAGLE-2, will compare gepotidacin against nitrofurantoin in about 1,200 females with an uncomplicated UTI.