GlaxoSmithKline has reported positive late-stage data showing the benefit of its biologic Nucala (mepolizumab) in patients with nasal polyps in patients requiring further surgeries for the condition.

The pivotal SYNAPSE study met both co-primary endpoints with the drug, when added to standard of care, demonstrating statistically significant improvements in both the size of nasal polyps and in nasal obstruction compared to placebo added to standard of care.
According to the data, the difference in median change from baseline for the total endoscopic nasal polyps score was -0.73, while the difference in median change from baseline for nasal obstruction visual analogue scale score was -3.14.
The results show that Nucala “represents a promising alternative for patients who are caught in a cycle of surgeries,” noted Claus Bachert, Professor and chief of Clinics ENT Department at Ghent University. “Each surgery carries risks and can disable the patient for several weeks”.
GSK says this is the first time an anti-IL5 biologic has reported positive Phase III data for nasal polyps, adding to the range of eosinophil-driven diseases in which Nucala has efficacy data.

Sanofi has unveiled more detailed late-stage data showing the benefit of biologic Dupixent (dupilumab) in a population of young patients with uncontrolled severe atopic dermatitis.

Phase III trial results show significantly improved disease signs, symptoms and health-related quality of life in children aged six-11 years with uncontrolled severe atopic dermatitis given the drug combined with standard-of-care topical corticosteroids (TCS). At 16 weeks, nearly three times as many children achieved clear or almost clear skin when treated with Dupixent and TCS, and more than two-thirds experienced at least a 75% overall improvement of their disease compared to TCS alone. Also, more than three times as many children experienced a significant reduction in itch with Dupixent compared to TCS alone. Improvements in itch and disease severity were observed with Dupixent as early as two weeks after the first dose and continued throughout active treatment. On the safety side, overall rates of adverse events were 65% for Dupixent every four weeks, 67% for Dupixent every two weeks and 73% for TCS alone.

Verona Pharma has reported positive efficacy and safety data for ensifentrine in chronic obstructive pulmonary disease (COPD) patients, showing that the drug demonstrated a meaningful increase in lung function.

A single dose of pressurised metered-dose inhaler formulation showed improvements in peak FEV (forced expiratory volume; a key measure of lung function), average FEV over four hours and average FEV over 12 hours. The ensifentrine pMDI formulation was also well tolerated at each dose with an adverse event profile similar to placebo, the firm noted. Verona says on the back of the positive data it will initiate a second, multiple dose, part of the study (Part B) at a later date, which will evaluate the pMDI formulation in this patient population over seven days of twice daily treatment.