GSK Says Depemokimab For Chronic Rhinosinusitis Reduces Nasal Polyp Size, Nasal Obstruction Versus Placebo At One Year

Benzinga · 10/14 12:39

On Monday, GSK plc (NYSE:GSK) released headline results from the phase 3 trials ANCHOR-1 and ANCHOR-2, which assessed the efficacy and safety of depemokimab versus placebo in adults with chronic rhinosinusitis with nasal polyps (CRSwNP).

Both trials met their co-primary endpoints of 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.

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The overall incidence and severity of treatment-emergent adverse events across both trials were similar in patients treated with either depemokimab or placebo.

Further analysis of these data is ongoing. The full results of ANCHOR-1 and ANCHOR-2 will be presented at an upcoming scientific congress.

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK, said: “Globally millions of people suffer from uncontrolled CRSwNP, the majority of whom will exhibit markers of type 2 inflammation. These patients have high corticosteroid exposure and often experience recurrence of nasal polyps following surgery. We’re 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.”

CRSwNP is a chronic condition that affects up to 4% of the general population, of whom 40% have uncontrolled disease.

It is caused by inflammation of the nasal lining that can lead to soft tissue growth, known as nasal polyps.

People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance, infections, and nasal discharge.

Data from ANCHOR-1 and ANCHOR-2 and the Phase 3 trials, SWIFT-1 and SWIFT-2, of depemokimab in severe asthma will be used in regulatory filings.

Depemokimab is an ultra-long-acting biologic administered once every six months.

Price Action: GSK stock is up 0.80% at $39.14 during the premarket session at last check Monday.

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