GSK (LSE: GSK) has announced positive results from its Phase III clinical trials evaluating the efficacy and safety of daprodustat in patients with nasal polyps. The trials met their primary endpoints, demonstrating a statistically significant improvement in nasal congestion and polyp size compared to placebo.
The Phase III trials, designed as randomized, double-blind, placebo-controlled studies, enrolled patients with symptomatic nasal polyps despite standard-of-care treatment with intranasal corticosteroids. Patients were administered daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), over a period of 16 weeks. The primary endpoints assessed were the change from baseline in nasal congestion score and nasal polyp score, as evaluated by endoscopy.
According to GSK, the results showed that daprodustat led to a clinically meaningful and statistically significant reduction in both nasal congestion and polyp size. The safety profile of daprodustat in these trials was consistent with previous studies. Detailed results from the Phase III trials will be presented at upcoming medical conferences and submitted for publication in peer-reviewed journals.
Nasal polyps are noncancerous growths that develop in the nasal passages or sinuses, often leading to nasal congestion, facial pain, and reduced sense of smell. Current treatment options include intranasal corticosteroids and, in severe cases, surgery. However, many patients continue to experience symptoms despite these treatments, highlighting the need for new therapeutic options.
Daprodustat, originally developed for anemia associated with chronic kidney disease, has shown potential in modulating inflammatory pathways relevant to nasal polyp pathogenesis. By targeting HIF-PHI, daprodustat may help reduce inflammation and promote polyp regression, offering a novel approach to managing this chronic condition. The successful Phase III results suggest that daprodustat could provide a valuable alternative or adjunct therapy for patients with nasal polyps, potentially improving their quality of life and reducing the need for surgery.
