Patients on the biologic had rapid and significantly improved asthma control and lung function.
Patients taking rademikibart had better asthma control and lung function compared with those taking placebo, according to a phase 2 trial.
“Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy,” the authors wrote in the American Journal of Respiratory and Critical Care Medicine.
More than 300 adults with moderate-to-severe, persistent, uncontrolled asthma were given the IL-4Rα-targeting antibody or placebo subcutaneously for 24 weeks.
The trial, which was funded by Connect Biopharma, randomly allocated patients to either 150mg or 300mg of the drug every other week, after a 600mg loading dose, or the placebo.
Patients in both intervention groups experienced lung function improvements, measured by prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1) at 12 weeks.
“Lung function improvements were larger than in trials of other biologic therapies and accompanied by rapid and significantly improved asthma control and potential for reduced incidence of exacerbations,” the authors wrote.
The researchers found lung function improved rapidly during the first week and were sustained until the end of the study. It was the most improved in patients with high baseline blood eosinophils.
“Airway obstruction was moderate at baseline in each treatment group, improving to be mild in both rademikibart groups from week 1 through week 24, whereas obstruction remained classified as moderate in the placebo group,” they wrote.
Patients in the intervention groups had statistically significant improvements in asthma control compared with placebo by the second week of treatment, and this difference continued until the end of the six-month trial. These improvements were clinically meaningful for most patients in the rademikibart groups, according to the authors.
Exacerbations were also reduced in the treatment groups.
“Through week 24, proportions of patients with ≥1 exacerbation were 7.5% (150mg) and 9.3% (300mg) vs 16.7% (placebo),” they found.
Nevertheless, one in 10 patients did not complete treatment.
“Treatment-emergent adverse events (TEAEs) were generally similar to placebo, and no eosinophilia was observed. Injection site reactions were mostly mild. The most common TEAEs (10-12% of patients) were cough, covid-19 and dyspnea,” the authors wrote.
“The results of the WW002 phase 2b indicate that a substantial number of patients, who are burdened with uncontrolled asthma and poor lung function, may benefit from treatment with rademikibart.”
