Express is expected to be the first in 20 years! Two pivotal Phase 3 trials of GSK reached the primary endpoint and recruitment was stopped early

GSK today announced the early suspension of recruitment
for two pivotal Phase 3 trials of its investigational drug Gepotidacin, on the recommendation of the Independent Data Monitoring Committee (IDMC).
This decision is based on positive data
from an interim analysis of the intended efficacy and safety of this drug in the treatment of more than 3,000 adult women or adolescents with uncomplicated urinary tract infections (uUTIs, also known as acute cystitis).
GSK expects to submit a New Drug Application (NDA)
to the US FDA in the first half of 2023.
If approved, this drug could become the first innovative oral antibiotic to treat uUTIs in more than 20 years!

Currently, millions of people around the world are infected by highly resistant superbugs, and about 700,000 people die each year from drug-resistant infections
.
The uUTI common in women is caused by Escherichia coli and Staphylococcus saprophytes (S.
saprophytes).
saprophyticus), it is estimated that one in three women has experienced at least one uUTI infection
before the age of 24.
Approximately 30-44% of uUTI cases will recur
.
uUTIs have a problem
with resistance to first-line drugs.
No new oral antibiotics have been developed for more than 20 years, so the development of new antibiotics to combat the widespread problem of drug-resistant infections has become an urgent need
to treat this disease.

Gepotidacin is an antibiotic with a new mechanism of action, which can be taken orally and has a dual mechanism of action, which can selectively bind and inhibit DNA gyrase and DNA topoisomerase IV at the same time, thereby inducing single-strand breaks in DNA during the replication process, thereby achieving the purpose of
killing pathogens.

Image source: 123RF

EAGLE-2 and EAGLE-3 are two similar phase 3 trials to compare the efficacy and safety of gepotidacin (1500 mg orally twice daily for 5 days) compared with an antibiotic active control group in the treatment of adult and adolescent female uUTI patients
。 According to the press release, both trials met the primary endpoint of achieving a clinical-microbial combination of remission in patients with eligible urinary tract pathogens in those with eligible urinary tract pathogens compared with an active control group
at the Test-of-Cure (TOC).
IDMC did not find any safety issues
in the trial.

Dr Chris Corsico, Senior Vice President, Development at GSK, said: "uUTIs are the most common infection among outpatients, with more than half of women developing the disease in their lifetime and more than a quarter suffering from recurrent uUTIs
.
No new antibiotic
has been developed for the disease for more than 20 years.
With the increase in uUTI cases caused by drug-resistant bacteria, the development of
new antibiotic therapies is necessary.
Due to the drug's demonstrated efficacy, the IDMC recommends an early cessation of enrollment in the EAGLE-2 and EAGLE-3 trials, providing an opportunity
to work with regulation to bring this new antibiotic to uUTI patients.
”

Resources:

[1] EAGLE-2 and EAGLE-3 phase III trials for gepotidacin stopped early for efficacy following pre-planned interim analysis by Independent Data Monitoring Committee.
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