GSK's SWIFT trial anthology shows long-acting treatment reduces asthma attacks
21 May 2024
Phase 3Clinical Result
Preview
Source: FierceBiotech
Center stage is depemokimab, a biologic GSK calls “ultra-long-acting” with a binding affinity and high potency for interleukin-5.
It’s not a double album release, but it’s a close runner-up: The pivotal SWIFT-1 and SWIFT-2 trials have shown that GSK's long-acting asthma treatment reduces attacks.
Center stage is depemokimab, a biologic GSK calls “ultra-long-acting” with a binding affinity and high potency for interleukin-5. IL-5 is a known key protein for asthma patients with type 2 inflammation, a condition that elevates levels of a white blood cell called eosinophils.
Both SWIFT trials were 52-week, placebo-controlled studies assessing depemokimab’s efficacy and safety among patients experiencing severe asthma with type 2 inflammation characterized by eosinophil count. Participants in each trial were randomized to receive depemokimab or placebo, plus their standard of care treatment with medium- to high-dose inhaled corticosteroids and at least one more controller.
The studies both demonstrated a drop in the annualized rate of clinically significant asthma attacks over 52 weeks for patients receiving depemokimab compared to placebo, meeting the trials’ primary endpoint. Though specific data weren’t shared, GSK said in a May 21 release that the findings are statistically significant.
The incidence and severity of treatment-emergent adverse events were similar in patients receiving depemokimab or placebo across both trials, according to the pharma.
Depemokimab is designed to allow for six-month dosing intervals and, if approved, would be the first ultra-long-acting biologic with that dosing schedule to hit the severe asthma market.
“Depemokimab could offer the possibility of sustained inhibition of this pathway, with a dosing schedule of just two injections per year,” Kaivan Khavandi, GSK senior vice president and global head of respiratory/immunology R&D, said in the news release. “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.”
Further analysis of the data is ongoing, with full SWIFT results slated for release at an upcoming scientific meeting. Those findings will be used to support global regulatory submissions, according to GSK.
The pharma hopes depemokimab’s alchemy can produce a winning streak across a range of other IL-5 mediated diseases, assessing the drug in phase 3 trials among patients with eosinophilic granulomatosis with polyangiitis, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Depemokimab is one of GSK’s 12 blockbuster launches expected over the next few years, CEO Emma Walmsley outlined in an earnings call in January. The pharma has previously said it anticipates the drug to generate peak yearly sales of 3 billion pounds sterling, if approved.
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