UK-based pharmaceutical company GSK has announced positive results from the Phase III ANCHOR-1 and ANCHOR-2 clinical trials of depemokimab in adults with chronic rhinosinusitis with nasal polyps (CRSwNP).
The full analysis set included 143 patients in the depemokimab arm and 128 in the placebo arm in ANCHOR-1, as well as 129 patients treated with depemokimab and 128 given placebo in ANCHOR-2.
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The replicate trials aimed to assess the safety and efficacy of depemokimab compared with placebo.
They both successfully met their co-primary endpoints, indicating a significant improvement in patients treated with depemokimab versus placebo.
Both trials achieved a change from baseline in total endoscopic nasal polyp score at 52 weeks and a change from baseline in mean nasal obstruction score from weeks 49 to 52.
GSK said these results suggest that depemokimab could be a significant advancement in the treatment of CRSwNP.
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By GlobalDataSimilar treatment-emergent adverse events were reported for both treatment arms, with further analysis of the data currently under way.
Depemokimab is an ultra-long-acting biologic with a high affinity for interleukin-5 (IL-5), a key cytokine in type 2 inflammation commonly found in nasal polyp tissue.
Its extended half-life and high potency allow it to be administered once every six months, offering a potentially more convenient treatment regimen for patients with CRSwNP.
The data from the ANCHOR trials, along with results from the SWIFT-1 and SWIFT-2 Phase III trials in severe asthma, will support regulatory filings for the asset.
GSK Respiratory/Immunology R&D senior vice-president and global head Kaivan Khavandi said: “We are very encouraged by the results from the ANCHOR studies, which demonstrate the potential for depemokimab to offer targeted and sustained suppression of a key inflammatory pathway underlying nasal polyp growth and nasal obstruction.
“This data, along with recent Phase III data in severe asthma, will be used in regulatory filings around the world.“
