Drug manufacturer AstraZeneca reported that its drug for treating patients with chronic COPD, Fasenra (benralizumab), did not achieve statistical significance in the primary endpoint of the RESOLUTE phase 3 trial.
The company said in a news release that the primary endpoint was the annualized rate of moderate or severe exacerbations in patients with three or more exacerbations in the previous year. While there was some improvement, the overall reduction in moderate to severe exacerbations was not statistically significant.
Sharon Barr, executive vice president of biopharmaceuticals research and development at AstraZeneca, said the company will continue its research of the drug and other treatments for COPD. She added that Fasenra is still viable as a treatment for other illnesses including asthma.
“We continue to advance other promising approaches in our pipeline to address the unmet needs of patients,” Barr said. “With its well-established ability to target and eliminate eosinophils, Fasenra has helped transform treatment of severe asthma, and more recently [it] has demonstrated a significant effect in eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.”
The company said the safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine.
The RESOLUTE trial is a randomized, double-blind, placebo-controlled phase III trial aimed at evaluating the efficacy and safety of benralizumab in people with moderate to very severe COPD who have a history of frequent COPD exacerbations and an elevated blood eosinophil count.
In the trial, moderate COPD exacerbations were defined by symptomatic worsening of COPD requiring the use of systemic corticosteroids for at least three days and the use of antibiotics. Severe exacerbations were defined by hospitalization due to COPD.
