27th Jun 2023 08:21
(Alliance News) - GSK PLC on Tuesday reported that the US Food & Drug Administration has granted its gonorrhoea investigational vaccine a "fast track" designation.
GSK, the Brentford, London-based pharmaceutical company, said that the "fast track" designation would facilitate the development and accelerate the review process of the drug.
The vaccine candidate for gonorrhoea is currently in its ongoing phase II trial, and aims to demonstrate proof of concept by assessing the vaccine's efficacy in healthy adults between the ages of 18 and 50 that are at risk of the virus.
Gonorrhoea is the second most sexually transmitted infection worldwide, caused by a bacterium called Neisseria gonorrhoeae, with an estimated 82 million new cases globally each year.
Antimicrobial resistance to gonorrhoea has increased over the past 80 years which has rendered many classes of antibiotics to treat the disease ineffective.
Global Head of Vaccines Research & Development Phil Dormitzer said: "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."
GSK's phase I trial was a 'first time in human' dose-escalation safety lead-in conducted in healthy adults that has now been completed.
Phase II trials started in November, enrolling 750 subjects from 8 countries.
Shares in GSK were up 0.6% at 1,428.20 in London on Tuesday morning.
By Will Neill, Alliance News reporter
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