GSK shares were up 2.2% to 1,748.3p in early morning trading on Friday, after the pharmaceutical company announced positive results for its respiratory syncytial virus (RSV) vaccine candidate for older adults.
GSK’s AReSVi 006 phase three trial vaccine candidate was reportedly the first of its sort to display clinically meaningful efficacy in adults aged 60 or over, with the magnitude of effect displaying consistency across RSV A and B strains, key secondary endpoints and in participants aged 70 or above.
The RSV vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen combined with the firm’s proprietary AS01 adjuvant, which has been utilised in several of GSK’s established adjuvanted vaccines.
GSK said it aimed for the antigen and adjuvant combination to help overcome natural age-related decline in immunity that contributes to the challenge of shielding older adults from RSV disease.
The interim analysis was reviewed by an Independent Data Monitoring Committee, and the group commented that the primary endpoint was exceeded with no unforeseen safety concerns noted.
GSK confirmed it would kick off engagement with regulators immediately, with regulatory submissions anticipated in HY2 2022.
The findings from the trial are scheduled for presentation in a peer-reviewed publication and at a scientific meeting later this year.
The trial is set to continued evaluation of an annual revaccination schedule and longer-term protection across several seasons with a single dose of the RSV older adult vaccine candidate.
“These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection,” said GSK chief scientific officer and research and development president Dr Hal Barron.
“RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalisations and more than 24,000 deaths worldwide each year.”
“Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”
