Home Pharma GSK preps filing for novel antibiotic for urinary tract infections –

GSK preps filing for novel antibiotic for urinary tract infections –

by MarketNews
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In a promising development to combat antimicrobial resistance (AMR), GSK’s novel antibiotic gepotidacin has shown efficacy in two Phase 3 trials and is preparing for regulatory submission.

If approved, gepotidacin (GSK2140944), a new class of oral antibiotics for uncomplicated urinary tract infections (UTIs), could become the first drug in more than 20 years. First half of next year.

Importantly, gepotidacin has an entirely new mechanism of action, circumventing resistance to current antibiotics, inhibiting DNA replication via two distinct type II topoisomerase enzymes, and preventing pathogens from acquiring resistance. should make it more difficult.

A study by the Pew Charitable Trust published in 2020 found that triazaacenaphthylene is one of only three antibiotics to offer a new, well-defined mechanism of action in late-stage trials. I was.

Two Phase 3 trials – called EAGLE-2 and 3 – GSK’s drug was discontinued early by the Data Oversight Board after an interim review of data showed clear efficacy and safety.

The study involved more than 3,000 female adults and adolescents with uncompleted urinary tract infections, and a 5-day oral course of gepotidacin achieved combined clinical and microbiological responses to infection in 28 days. was shown to be as effective as the standard therapy, nitrofurantoin, in

Another study, called EAGLE-1, compared two oral doses of gepotidacin with an intramuscular injection-based regimen of ceftriaxone and oral azithromycin in the treatment of urogenital gonorrhea.

According to Chris Crisco, Head of Development at GSK, uncomplicated UTI is the most common foreign infection affecting more than half of all women during their lifetime, with more than a quarter of them recurring. I am suffering from a sexually transmitted disease. The number of UTIs caused by resistant pathogens is also increasing, he said.

“…recommending early termination of trials of EAGLE-2 and 3 to confirm efficacy provides GSK with an opportunity to work with regulatory authorities to bring this new class of antibiotics to patients. Got it.”

AMR is a growing problem, it’s already a problem 1.2 million lives per year That number is expected to rise to 10 million by 2050, unless new drugs or other means to control the infection become available.

There are serious concerns that we are entering a post-antibiotic era where even the slightest infection can kill a patient. GSK is one of the few big pharma companies to do research and development of new antibiotics after a massive spill out of this category over the past few decades.

The main problem is that investment in antibiotic development is unattractive. New drugs tend to be reserved for patients with multidrug-resistant infections and used sparingly, so developers cannot recoup their costs.

The pharmaceutical industry has taken other steps, such as pooling R&D spending to support biotech working in this field, for example through the AMR Action Fund, which backed projects by Adaptive Phage Therapeutics (APT) and Venatorx Pharmaceuticals earlier this year. measures are being taken.

Additionally, efforts are being made to change the commercial model for antibiotics to reduce the risk of antibiotic development.

The UK government is addressing this dynamic by launching ‘Netflix-style’ subscription payments for new antibiotics, allowing access regardless of how much is used to treat a patient, in exchange for a fixed annual fee. The first drugs were included in that plan earlier this year.

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