GlaxoSmithKline kick-starts first-of-its-kind late-stage antibiotic test

It won’t stuff your pockets with profits and it’s not sexy, but GlaxoSmithKline is pushing forward into a phase 3 study for its antibiotic work as governments continue to sound the alarm of an antibiotic-resistant future.

The London-based company is one of the last few pharmas still working on antibiotics, and it's now looking for a phase 3 trial for its first in a new chemical class of antibiotic with a mechanism of action “distinct from any currently approved antibiotic,” GSK said in a statement.

The drug, known as gepotidacin, part of a class known as triazaacenaphthylene bacterial topoisomerase inhibitors, is being tested in the late-stage program in patients with uncomplicated urinary tract infection (uUTI, also known as acute cystitis) and urogenital gonorrhea (GC).

Though it’s not here alone: Gepotidacin comes out of a public-private partnership between GSK, the U.S. government’s Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency. This collab was set up back in 2013, with GSK working on the drug since 2007.

Hal Barron, M.D., chief scientific officer and president of R&D at GSK, said: “Given the increasing rate of antibiotic drug resistance, and gepotidacin’s unique mechanism of action, we believe this drug has the potential to transform the treatment landscape for patients with uncomplicated urinary tract infection and urogenital gonorrhea who currently have limited therapeutic options.”

The first study (EAGLE-1) will compare gepotidacin to ceftriaxone plus azithromycin in around 600 patients with GC, while the second (EAGLE-2) will compare gepotidacin to nitrofurantoin, a licensed first-line antibiotic, in twice the number of patients with uUTI.

Expect the first tranche of data “at the end of 2021,” the company said.

There haven’t been many new antibiotics on the market over the past few decades, and antimicrobial resistance—whereby bacteria are evolving to not be killed by older antibiotics—could leave open the possibility that once easily treated infections again become a deadly scourge, should new antibiotics not be made.

The issue for pharma is that there is little to no ROI for antibiotic R&D, given that one of the key things you’d do with these drugs is not give them out readily.

Cancer and rare disease drug R&D, while costly, will always see a much greater return, so those have become the mainstay focus of most Big Pharmas, with only a handful involved in antibiotic work.

Governments are working on new ways to better incentivize pharmas and biotechs to produce new and next-gen antibiotics, though at the moment collabs and public-private deals seem to be the way forward.