The US FDA granted Fast Track designation to NgG, since gonorrhoea is recognised as an urgent unmet medical need, based on its growing incidence worldwide, reduced efficacy of available treatments, with increasing drug-resistant strains
Pipette work at our R&D laboratory in Branford, US. (Credit: GSK plc.)
UK-based pharmaceutical company GSK has received the US Food and Drug Administration (FDA) Fast Track designation for its Neisseria gonorrhoea investigational vaccine (NgG).
NgG is currently being evaluated in an ongoing Phase 2 clinical trial to assess its efficacy in healthy adults, aged 18 to 50 years, considered at risk of gonorrhoea.
Gonorrhoea is the world’s second most prevalent bacterial sexually transmitted infection (STI), caused by a bacterium called Neisseria gonorrhoeae (Ng).
Ng infection in women is often asymptomatic and under-diagnosed and may lead to complications and long-term consequences, if left untreated.
It is recognised as an urgent unmet medical need due to its growing incidence worldwide, reduced efficacy of available treatments, with increasing drug-resistant strains.
The US FDA Fast Track designation is intended to expedite the review of new drugs and vaccines for serious conditions with unmet medical needs.
GSK Vaccines R&D global head Phil Dormitzer said: “We welcome the FDA’s decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection.
“With a high and growing incidence, gonorrhoea is a major concern for sexual and reproductive health around the globe.
“This designation recognises the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a ‘high priority’ pathogen by the World Health Organisation.”
According to GSK, Antimicrobial resistance (AMR) to gonorrhoea has increased over the past 80 years, and currently, there are no gonorrhoea vaccines approved anywhere in the world.
Vaccines play an important role in the fight against AMR by preventing bacterial, viral, and other infections.
GSK is conducting a Phase 1/2 first-time-in-human study (FTiH) trial of NgG, evaluating its safety and efficacy in individuals aged 18-50 years old, regardless of gonorrhoea history.
The company has already completed the Phase 1 study, an FTiH dose-escalation safety study.
The ongoing Phase 2 study was started in November last year, with plans to enrol around 750 subjects in the US, the UK, France, Germany, Spain, Brazil, the Philippines, and South Africa.
Recently, GSK has secured US FDA and European Commission (EC) approvals for Arexvyv, its adjuvanted respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD), in the older population.