GSK's Gepotidacin Oral Antibiotic Non-Inferior To Commonly Used Muscle-Injected Antibiotic Combo For Sexually Transmitted Infection

Monday, GSK plc GSK released headline results from the pivotal EAGLE-1 phase 3 trial for gepotidacin, an oral antibiotic for uncomplicated urogenital gonorrhea in adolescents and adults. 

The trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a leading combination treatment regimen for gonorrhea. 

The result is based on a primary endpoint of microbiological response (success or failure) at the Test-of-Cure (ToC) visit 3-7 days after treatment.

Also Read: GSK Upgrades Long-Term Outlook After Q4 Performance, Shingrix Vaccine And Newly Launched RSV Vaccine Shine.

Gonorrhea is a sexually transmitted infection caused by bacteria called Neisseria gonorrheae. It has been estimated that there are 82 million new cases globally each year. In the U.S., rates of reported gonorrhea have increased by 118% from 2009 to 2021, with 648,056 cases being reported to the US Centers for Disease Control and Prevention in 2022. It increases the risk of HIV infection.

The safety and tolerability profile of gepotidacin in the EAGLE-1 phase 3 trial was consistent with results seen in gepotidacin phase 1 and 2 trials.

“These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance,” said Chris Corsico, GSK’s senior vice president of development.

GSK is also developing gepotidacin for uncomplicated urinary tract infections (uUTI). Phase 3 data from the EAGLE-2 and EAGLE-3 trials were presented at the European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen in April 2023 and published in The Lancet.

If approved, gepotidacin could be the first in a new class of oral antibiotics in uUTI in over 20 years.

The development of gepotidacin has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, and federal funds awarded by the Defense Threat Reduction Agency.

Price Action: GSK shares are up 0.68% at $42.51 on the last check Monday.

Photo: Darko Stojanovic from Pixabay