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(Sharecast News) - GSK announced promising results from phase three clinical trials evaluating the efficacy and safety of depemokimab in treating severe asthma with type 2 inflammation on Tuesday.
The FTSE 100 pharmaceuticals giant said the trials reached their primary endpoints, demonstrating statistically significant and clinically meaningful reductions in asthma exacerbations over 52 weeks compared to placebo.
It said depemokimab, an ultra-long-acting biologic targeting interleukin-5 (IL-5), could become the first approved treatment with a six-month dosing schedule for severe asthma, expected to simplify treatment for millions of patients.
The trials included 375 and 380 participants, respectively, who received either depemokimab or placebo alongside their standard asthma treatments.
GSK said the incidence and severity of adverse events were similar between the depemokimab and placebo groups.
Full results would be presented at an upcoming scientific congress and would support global regulatory submissions.
Further research was ongoing, including the AGILE open-label extension study and the NIMBLE trial, assessing the transition from other biologics to depemokimab.
Additionally, depemokimab was being investigated for other IL-5 mediated diseases such as eosinophilic granulomatosis with polyangiitis, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
"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," said Kaivan Khavandi, senior vice-president and global head of respiratory and immunology research and development.
"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."
Reporting by Josh White for Sharecast.com.
