GSK trials for chronic rhinosinusitis drug meet primary endpoints

1 November 2024
GSK has revealed promising results from its respiratory program involving the investigational drug depemokimab, focusing this time on patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The data comes from the Phase 3 ANCHOR-1 and ANCHOR-2 trials, both of which successfully met their co-primary endpoints. These endpoints included the total endoscopic nasal polyp score at 52 weeks and the mean nasal obstruction score from weeks 49 to 52. The trials indicated that treatment-emergent adverse events were comparable between patients receiving the drug and those on placebo. GSK emphasized that depemokimab, with its long-acting potential, could be administered once every six months.

Kaivan Khavandi, GSK’s Senior Vice President and global head of respiratory and immunology R&D, stated that the trial data would be utilized in regulatory filings worldwide. Khavandi highlighted the challenges faced by patients who often undergo surgery and have high exposure to corticosteroids, only to experience recurring nasal polyps. He noted that the trial results suggest depemokimab could provide targeted and long-lasting suppression of the inflammatory pathways responsible for the growth of nasal polyps and nasal obstruction.

CRSwNP is a chronic condition characterized by inflammation of the nasal lining, which can lead to the development of nasal polyps and symptoms such as loss of smell and facial pressure. It impacts up to 4% of the general population. If approved, depemokimab, which targets interleukin-5 (IL-5), is anticipated to generate peak annual sales of £3 billion ($3.9 billion).

This announcement follows another set of positive data released just a month earlier in September. In that instance, GSK reported that depemokimab reduced asthma attacks by 54% in two extensive Phase 3 trials. However, those studies did not achieve statistical significance on secondary endpoints related to quality-of-life and symptom-based measures.

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