GSK announced Tuesday morning that its experimental antibody treatment reduced the yearly rate of asthma attacks across two key clinical trials for adolescents and adults with a form of severe asthma.
The treatment, depemokimab, is a long-acting antibody that targets interleukin-5 (IL-5), a regulator of the body’s immune response. It’s the same target as GSK’s approved asthma drug Nucala, which generated £1.66 billion ($2.1 billion) in sales in 2023. While Nucala is dosed monthly, depemokimab can be dosed at six-month intervals.
The company plans to file for regulatory approval in the US in the second half of 2024, and in the EU, China and Japan in 2025, GSK said in an email to Endpoints News.
The two depemokimab Phase 3 trials included participants with severe asthma with type 2 inflammation — which is typically characterized by elevated counts of a type of white blood cell that promotes inflammation. In both trials, SWIFT-1 and SWIFT-2, depemokimab reduced the yearly rate of asthma attacks, and the severity and amount of adverse events following treatment were similar to placebo.
GSK hopes that, if approved, depemokimab can reach peak year sales of £3 billion.
With Nucala, GSK currently competes with AstraZeneca’s treatment Fasenra, which generated $1.55 billion in revenue in 2023. GSK is also studying depemokimab in participants with severe asthma who switch from Nucala or Fasenra in a Phase 3 study called NIMBLE, which expects to recruit 1,700 participants, according to a federal clinical trials database.
Full results from the SWIFT studies will be presented at a future scientific meeting, the company said.