Second Most Prevalent Bacterial Sexually Transmitted Infection: GSK's Gonorrhea Vaccine Secures FDA Track

The FDA has granted Fast Track designation to GSK plc's (NYSE: GSK) investigational vaccine for Neisseria gonorrhea. The vaccine is currently in an ongoing Phase 2 trial.

The trial aims to demonstrate proof of concept by assessing the vaccine's efficacy in healthy adults aged 18 to 50, considered at risk of gonorrhea.

Gonorrhea is the second most prevalent bacterial sexually transmitted infection worldwide, with an estimated 82 million new cases yearly.

There are currently no approved vaccines for gonorrhea anywhere in the world.

Also Read: GSK's Meningitis Vaccine Candidate: Crushing Clinical Trials or Just Playing Catch-up with Bexsero and Menveo?

Antimicrobial resistance to existing treatments is increasing.

Gonorrhea has seen a 118% increase in reported cases in the US from 2009 to 2021.

Antimicrobial resistance (AMR) to gonorrhea has increased over the past 80 years, rendering many antibiotics ineffective against the disease.

GSK says its Phase 1/2 trial is the first study evaluating the vaccine candidate's safety and efficacy in individuals aged 18-50, regardless of previous gonorrhea history.

Phase 1 of the study was a safety lead-in conducted in healthy adults and is now complete. Phase 2 of the study is ongoing.

The trial started in November 2022, and approximately 750 subjects will be enrolled from 8 countries.

Price Action: GSK shares are down 1.13% at $35.87 during the premarket session on the last check Tuesday.