GSK's Experimental Asthma Drug Reduces Severe Attacks, Phase 3 Trial Data Shows

Zinger Key Points
  • GSK says depemokimab has the potential to be the first approved ultra-long-acting biologic with six-month dosing schedule for severe asthma.
  • Depemokimab showed "significant and meaningful reductions" in asthma attacks for patients with eosinophilic asthma.

Tuesday, GSK plc GSK released headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterized by blood eosinophil count.

Earlier this year, GSK acquired Aiolos Bio Inc., a privately held asthma drug maker, for $1 billion.

Both SWIFT-1 and SWIFT-2 met their primary endpoints of a reduction in the annualized rate of clinically significant exacerbations (asthma attacks) over 52 weeks.

Across both trials, the overall incidence and severity of treatment-emergent adverse events were similar in patients treated with either depemokimab or placebo. The company said further analysis of data is ongoing.

Depemokimab is the first ultra-long-acting biologic to be evaluated in phase 3 trials with a binding affinity and high potency for interleukin-5 (IL-5), enabling six-month dosing intervals for patients with severe asthma. IL-5 is a key cytokine (protein) in type 2 inflammation.

This inflammation, typically identified by elevated blood eosinophil count, is the underlying pathology responsible for more than 80% of people with severe asthma and can lead to unpredictable exacerbations.

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said: “These results add to the established body of evidence that targeted inhibition of IL-5 plays a key role in reducing type 2 inflammation that drives severe asthma exacerbations.”

“Depemokimab could offer the possibility of sustained inhibition of this pathway with a dosing schedule of just two injections per year. This is important as research shows that 73% of physicians believe longer dosing intervals would be beneficial to patients who are often juggling multiple therapies.”

Price Action: GSK shares were down 0.74% at $44.26 during the premarket session at the last check on Tuesday.

Photo via Wikimedia Commons

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