▎WuXiEdited by the Kant Content Team

GSK announced today that the U.S. FDA has accepted the New Drug Application (NDA) for its potential "first-in-class" oral antibiotic gepotidacin, for the treatment of adults or adolescents (≥12 years) with uncomplicated urinary tract infections (uUTI, also known as acute cystitis).FemalePatients must weigh ≥40 kilograms. The FDA has granted this application priority review status and is expected to complete the review by March 26, 2025.According to the press release, if approved, gepotidacin will become the first new oral antibiotic drug for the treatment of uUTI in more than 20 years.

More than half of women will suffer from uUTI in their lifetime, and about 30% of women will experience recurrence.Due to the increasing number of uUTI cases caused by drug-resistant bacteria, which may lead to higher treatment failure rates, there is an urgent need to develop new therapeutic approaches.

The new drug application is supported by positive results from the pivotal Phase 3 EAGLE-2 and EAGLE-3 trials. In these studies,Compared with nitrofurantoin, the current standard therapy for uUTI, gepotidacin demonstrated non-inferiority in treating confirmed uUTI in adult and adolescent female patients., these patients are known to respond to nitrofurantoin.

▲Gepotidacin Molecular Structure (Image Source: PubChem)

In the EAGLE-3 trial, gepotidacin demonstrated statistically significant superiority compared to the active control drug.58.5% (n=162/277) of patients in the gepotidacin group were successfully treated, compared to 43.6% in the active comparator group.(n=115/264, difference 14.6%, 95% CI: 6.4~22.8). In the EAGLE-2 trial,50.6% (n=162/320) of patients in the gepotidacin group showed treatment success, compared to 47.0% in the active comparator group.(n=135/287, difference 4.3%, 95% CI: -3.6~12.1).

The safety and tolerability results of Gepotidacin in the EAGLE-2 and EAGLE-3 trials were consistent with previous trials.

GepotidacinIt is an antibiotic with a novel mechanism of action, which can be taken orally and has a dual mechanism of action, selectively binding to and inhibiting simultaneously.DNAGyrase andDNATopoisomeraseIV, thereby inducing in the replication processDNASingle-strand breaks occur, thereby achieving the goal of killing pathogens.

References:

[1] Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents. Retrieved October 16, 2024 from https://www.gsk.com/en-gb/media/press-releases/gepotidacin-accepted-for-priority-review-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections-in-female-adults-and-adolescents/

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media circles, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.