Confirmation of non-inferiority compared to existing treatments…To be discussed with global health authorities
[의약뉴스] GSK has proven the effectiveness of its oral antibiotic candidate gepotidacin in a phase 3 clinical trial for gonorrhea.
GSK announced positive headline results from EAGLE-1, a pivotal Phase 3 clinical trial evaluating gepotidacin, a first-in-class oral antibiotic with a novel mechanism of action, in adolescents and adults with uncomplicated genitourinary gonorrhea. It was announced on the 26th (local time).
▲ GSK succeeded in the phase 3 clinical trial of gepotidacin for simple urinary tract infection last year and also secured positive results in the phase 3 clinical trial for gonorrhea.
In the clinical trial, gepotidacin 3000mg administered twice met the primary efficacy evaluation index by demonstrating non-inferiority compared to intramuscular administration of ceftriaxone 500mg and oral azithromycin 1000mg administration, which are representative combination treatments for gonorrhea.
These results are based on the primary endpoint of microbiological response (success or failure) observed at the confirmation visit 3 to 7 days after treatment.
The safety and tolerability profile of gepotidacin in the EAGLE-1 Phase 3 clinical trial was consistent with results observed in previous Phase 1 and 2 clinical trials.
Detailed results will be presented at a future academic conference and will be shared with global health authorities.
Gonorrhea is a sexually transmitted infection caused by Neisseria gonorrhoeae, and it is estimated that 82 million new cases occur each year around the world.
It affects both men and women and, if untreated or inadequately treated, can cause infertility and other sexual and reproductive health complications and may increase the risk of HIV infection.
“Gonorrhea is a threat to public health globally, with increasing incidence and resistance to existing treatments,” said Chris Corsico, senior vice president of development at GSK. “It demonstrates the potential of gepotidacin to provide a treatment option and provide a new oral option for patients who cannot receive other treatments due to allergies or intolerances.”
Gepotidacin is the first bactericidal triazacenaphthylene antibiotic in its class discovered by GSK scientists. It inhibits bacterial DNA replication through a novel mechanism of action and binding site, and has two different types of type II topoisomerization against most pathogens. Inhibits enzymes (topoisomerase) in a balanced manner.
GSK is also developing gepotidacin as a treatment for uncomplicated urinary tract infections (uUTIs). Positive data derived from the phase 3 clinical trials EAGLE-2 and EAGLE-3 of gepotidacin for uncomplicated urinary tract infections were announced at the European Society for Clinical Microbiology and Infectious Diseases (ECCMID) in April last year and were published in the medical journal The Lancet. was published in
If gepotidacin is approved for simple urinary tract infections, it could become a new class of oral antibiotics for the first time in 20 years.
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2024-02-27 14:32:43
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