GSK Announces Positive Phase III Pivotal Data for Its Respiratory Syncytial Virus (RSV) Vaccine Candidate for Older Adults | GSK

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Posted: June 10, 2022, London, UK – LSE announcement

  • First RSV vaccine candidate to show statistically significant and clinically meaningful efficacy in adults aged 60 and older
  • The magnitude of the observed effect was consistent between RSV A and B strains, the primary secondary endpoints, and in people aged 70 years and older.
  • Engagement with regulators to begin immediately with regulatory submissions expected in the second half of 2022

GSK plc (LSE/NYSE: GSK) today announced positive topline results from a pre-specified interim efficacy analysis of the Phase III AReSVi 006 trial. The interim analysis has been reviewed by an independent committee monitoring data and the primary endpoint was exceeded without any unexpected safety issues being observed. AReSVi 006 is a Phase III trial of GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 and over.

Dr. Hal Barron, Scientific Director and President, R&D, GSK, said, “These data suggest that our candidate RSV vaccine offers exceptional protection to the elderly against the severe consequences of RSV infection. RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to have a significant impact on the treatment of RSV and could reduce the 360,000 hospitalizations and more than 24,000 deaths worldwide each year. Given the importance of this data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”

The results of this phase III trial will be presented in a peer-reviewed publication and at an upcoming scientific meeting. The AReSVi 006 trial will continue to assess both an annual revaccination schedule and longer-term protection over multiple seasons after one dose of the RSV vaccine candidate for older adults (OA).

GSK’s RSV OA vaccine candidate contains a recombinant subunit prefusion RSV F-glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant. AS01 is used with several of GSK’s established adjuvanted vaccines. The antigen plus adjuvant combination may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting the elderly against RSV disease.

About AReSVi 006

The Phase III AReSVi 006 trial is a randomized, placebo-controlled, observer-blinded, multi-country trial to demonstrate the efficacy of a single dose of the investigational RSVPreF3 OA vaccine with GSK’s adjuvant in adults aged 60 and over. About 25,000 participants were registered in 17 countries.

AReSVi 006 is part of a comprehensive RSV proof generation program conducted by GSK. Recent internal results from a parallel phase III trial, AReSVi 004, studying the immunogenicity, safety, reactogenicity and persistence of the candidate vaccine in the elderly showed that in participants aged 60 and over , one dose of the experimental RSV OA vaccine induced strong humoral and cellular immune responses, which remain above pre-vaccination levels until at least six months after vaccination.

AReSVi 006 is subject to close safety monitoring, with safety data reviewed internally and by an independent external data monitoring board on an ongoing basis.

About respiratory syncytial virus (RSV)

RSV is a common contagious virus affecting the lungs and respiratory tract. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment. Older people are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to serious consequences, such as pneumonia, hospitalization and death. Each year, RSV causes more than 360,000 hospitalizations and 24,000 deaths worldwide among adults. Adults with underlying conditions are more likely to see a doctor and have higher hospitalization rates than adults without these conditions.

About GSK

GSK is a science-driven global healthcare company. For more information, visit www.gsk.com/about-us.

Caution 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. These factors include, but are not limited to, those described in GSK’s Annual Report on Form 20-F for 2021 and any impacts from the COVID-19 pandemic.

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