GSK’s IL-5 Antibody Nucala Achieves Phase 3 Primary Endpoints in Chronic Rhinosinusitis with Nasal Polyps

Recently, GlaxoSmithKline (GSK) announced that its anti-IL-5 monoclonal antibody Nucala (mepolizumab) met the primary and key secondary endpoints in the pivotal Phase 3 SYNAPSE trial evaluating patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The press release noted that this marks the first time an anti-IL-5 biologic has demonstrated positive Phase 3 clinical data in the treatment of CRSwNP, further supporting its efficacy in treating eosinophil-driven diseases. GSK expects to complete the regulatory submission for this indication later this year.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic type 2 allergic inflammatory condition that leads to the growth of nasal polyps, obstructing the sinuses and nasal cavity, and causing symptoms such as severe nasal congestion, rhinorrhea, facial pain, and impaired sense of smell and taste. Long-term suffering from CRSwNP significantly impacts patients’ health and daily life. To date, treatment options for patients remain very limited, typically requiring intranasal and oral corticosteroids, or even surgery; however, recurrence rates are extremely high. Therefore, there is an urgent need for a safe, novel therapy to help them restore their quality of life.

As an IL-5 inhibitor, Nucala is a “first-in-class” monoclonal antibody therapy. By inhibiting the IL-5 signaling pathway, it is expected to reduce eosinophil growth and alleviate various diseases caused by eosinophilia. In 2015, it received approval from the U.S. FDA for the treatment of severe asthma.

Image Source: GSK ProposalSupply

The pivotal SYNAPSE study primarily targeted patients who had previously undergone surgical treatment but continued to experience severe symptoms and required further surgery due to polyp growth. This 52-week, randomized, double-blind, Phase 3 clinical trial met its primary endpoint. Compared with the control group receiving standard therapy alone, the combination of Nucala and standard therapy resulted in statistically significant improvements in nasal polyp size at both Week 49 and Week 52. Furthermore, the study reduced the need for initial surgery during the 52-week treatment period by 57%, which was the key secondary endpoint of the trial.

“Nasal polyps are a relatively common condition that affects people’s sleep, breathing, and sense of smell and taste,” said Dr. Hal Barron, Chief Scientific Officer and President of Research and Development at GSK. “The results of this trial demonstrate that Nucala can alleviate symptoms in patients with nasal polyps and reduce the need for surgery. We look forward to submitting the regulatory application for Nucala.”

References:

[1] Nucala (mepolizumab) is the first anti-IL5 biologic to report positive phase 3 results in patients with nasal polyps, Retrieved Apr 3, 2020, from https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-is-the-first-anti-il5-biologic-to-report-positive-phase-3-results-in-patients-with-nasal-polyps/

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