REG - GSK PLC - FDA Fast Track for Gonorrhoea Vaccine Candidate

GSKAnnouncement

27/06/2023 07:15

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RNS Number : 9658D  GSK PLC  27 June 2023

 

Issued: 27 June, London UK

 

GSK receives US FDA Fast Track designation for investigational vaccine against
gonorrhoea

 

·   Fast Track designation accelerates the vaccine candidate's path to US
FDA submission for the prevention of Neisseria gonorrhoeae infection

·   Gonorrhoea is the second most prevalent bacterial sexually transmitted
infection worldwide with an estimated 82 million new cases globally each
year 1  (#_edn1) (, 2  (#_edn2) )

·   Currently there are no vaccines approved anywhere in the world for
gonorrhoea, and antimicrobial resistance to existing treatments is increasing2

 

GSK plc (LSE/NYSE: GSK) announced today the US Food and Drug Administration
(FDA) has granted a Fast Track designation for its Neisseria gonorrhoeae
investigational vaccine (NgG). The vaccine candidate is currently in an
ongoing Phase II trial and aims to demonstrate proof of concept by assessing
the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of age,
considered at risk of gonorrhoea. Fast Track designation is intended to
facilitate the development and expedite the review of potentially important
new drugs and vaccines to treat or prevent serious conditions with unmet
medical needs.

 

Gonorrhoea is the second most prevalent bacterial sexually transmitted
infection (STI) worldwide1, with an estimated 82 million new cases globally
each year.(2) In the US, rates of reported gonorrhoea have increased 118% from
2009 to 2021, resulting in 710,151 cases being reported to the US Centers for
Disease Control and Prevention (CDC) in 2021.(( 3  (#_edn3) ))

 

Phil Dormitzer, Global Head of Vaccines R&D, GSK, 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."

 

Antimicrobial resistance (AMR) to gonorrhoea has increased over the past 80
years, rendering many classes of  antibiotics used to treat the disease
ineffective.2 Vaccines can play a critical role in the fight against AMR by
helping prevent bacterial, viral and other infections. At this time, there are
no gonorrhoea vaccines approved anywhere in the world. 4  (#_edn4)

 

About the Phase I/II trial

The trial conducted by GSK is a Phase I/II first time in human study (FTiH)
evaluating the vaccine candidate's safety and efficacy in individuals aged
18-50 years old, regardless of previous gonorrhoea history. Phase I of the
study was a FTiH dose-escalation safety lead-in conducted in healthy adults
and is now complete. Phase II of the study is ongoing and aims to demonstrate
Proof of Concept by assessing the efficacy of the NgG vaccine in healthy
adults considered at risk of gonorrhoea. The trial started in November 2022,
and approximately 750 subjects will be enrolled from 8 countries (US, UK,
France, Germany, Spain, Brazil, Philippines, South Africa).

 

 

About Gonorrhoea

Gonorrhoea is a sexually transmitted infection (STI) caused by a bacterium
called Neisseria gonorrhoeae (Ng). It is recognised as an urgent unmet medical
need due to its growing global incidence and reduced efficacy of available
treatments as drug-resistant strains are increasing.2 Ng infection in women is
often asymptomatic and under-diagnosed. When left untreated, Ng infection can
lead to complications and long-term consequences such as pelvic inflammatory
disease, infertility, ectopic pregnancy, and adverse pregnancy outcomes.(4)
Painful symptoms in men make gonorrhoea more likely to be diagnosed, 5 
(#_edn5) but stigma surrounding the disease is still a barrier to seeking
diagnosis and treatment.  It has also been shown that Ng infections may also
increase the risks of acquiring or transmitting HIV.5(,) 6  (#_edn6)

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com/company.

 GSK Enquiries
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                      Jeff McLaughlin          +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco         +1 215 751 4855       (Philadelphia)

 

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described under
Item 3.D 'Risk factors" in the company's Annual Report on Form 20-F for 2022,
and Q1 Results for 2023 and any impacts of the COVID-19 pandemic.

 

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(#_ednref1) References

 1 . Rowley et al. Chlamydia, gonorrhoea, trichomoniasis and syphilis: global
prevalence and incidence estimates, 2016. Bull World Health Organ. 2019
1;97(8):548-562. doi: 10.2471/BLT.18.228486.

 2  (#_ednref2) . WHO. Multi-drug resistant gonorrhoea. Available at:
https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea2022.
Accessed June 2023.

 3  (#_ednref3) . CDC. Sexually Transmitted Disease Surveillance. Available
at: https://www.cdc.gov/std/statistics/2021/figures.htm. Accessed June 2023.

 4  (#_ednref4) . Gottlieb S et al. Gonococcal vaccines: Public health value
and preferred product characteristics; report of a WHO global stakeholder

 5  (#_ednref5) . Fleming DT et al. From epidemiological synergy to public
health policy and practice: the contribution of other sexually transmitted
diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999
75(1)3-17. doi: 10.1136/sti.75.1.3.

 6  (#_ednref6) . Bernstein K et al. Rectal gonorrhoea and chlamydia
reinfection is associated with increased risk of HIV seroconversion. J Acquir
Immune Defic Syndr. 2010 1;53(4):537-43. doi: 10.1097/QAI.0b013e3181c3ef29.

 

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