GSK upbeat on meningitis vaccine candidate, asthma treatment

The FTSE 100 company said the vaccine, administered in two doses given six months apart, was tested in healthy individuals aged 10 to 25 years for safety, tolerability, and immunogenicity.

All primary endpoints were met, including the vaccine's non-inferiority for all five Neisseria meningitides serogroups - A, B, C, W, and Y - compared to licensed meningococcal vaccines Bexsero and Menveo.

The vaccine candidate was well tolerated, with a safety profile consistent with the existing meningococcal vaccines.

GSK noted that the current immunisation regime for IMD in the United States requires two separate vaccines and four injections to protect against all five serogroups.

That, coupled with low awareness of the disease, could lead to suboptimal immunisation coverage rates, particularly for MenB, with an estimated coverage of only approximately 31% of adolescents in the US.

GSK's MenABCWY combination vaccine candidate would offer a single vaccine solution for all five serogroups, the board explained, and could potentially improve immunisation coverage rates.

“These statistically significant phase three data are a very encouraging step toward reducing the incidence of meningococcal disease,” said chief scientific officer Tony Wood.

“In the US, routine use of a five-in-one meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease's incidence peak, could drive significant public health impact.

“In addition, our five-in-one meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and commitment to innovation.”

In a separate announcement, GSK revealed that China's National Medical Products Administration had accepted a new drug application for Nucala, or mepolizumab, for review as an add-on maintenance treatment for severe eosinophilic asthma (SEA).

If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in China for adult and adolescent patients with this condition.

The company said the application was based on positive data from a phase three trial among Chinese patients and the global SEA development programme, which included three key clinical trials that established the efficacy and safety profile of mepolizumab for severe eosinophilic asthma patients.

Nucala was currently approved in China for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA), and was included on the National Reimbursement Drug List in January.

It was not, however, currently approved in China for the treatment of SEA.

“Nucala has been studied in over 4,000 patients in 41 clinical trials across several eosinophilic indications and was the first treatment approved in the US across four eosinophil-driven diseases - SEA, EGPA, hypereosinophilic syndrome and chronic rhinosinusitis with nasal polyps,” GSK said in its statement.

“Nucala has been approved in the US, the European Union and over 25 other markets as an add-on maintenance treatment for patients with SEA.”

At 0918 GMT, shares in GSK were up 0.39% at 1,382p.

Reporting by Josh White for Sharecast.com.