AstraZeneca (NYSE:AZN) today touted results from a Phase III extension trial evaluating the long-term safety and efficacy of benralizumab as an add-on maintenance therapy for patients with severe eosinophilic asthma.
Benralizumab, or Fasenra, is approved as an add-on maintenance treatment for severe eosinophilic asthma in an array of countries, including the U.S., the E.U., and Japan.
The Phase III extension Bora trial included people who had previously completed one of the two pivotal Sirocco or Calima Phase III trials.
In the 56-week Bora trial, investigators observed a safety and tolerability profile for Fasenra that was similar to the one observed in AstraZeneca’s pivotal trials. The participants’ improvements in efficacy measures were maintained over the year of additional treatment, researchers added.
The study participants who were treated with placebo in the pivotal trials and then transitioned to Fasenra in the Bora trial also experienced improvements in efficacy outcomes.
AstraZeneca noted that 74% of participants with a baseline blood eosinophil count of 300 cells per μL or greater who received Fasenra every eight weeks were exacerbation-free during the Bora trial and maintained improvements in lung function and asthma control.
The overall yearly asthma exacerbation rate for participants with baseline blood eosinophil counts of 300 cells per μL or greater was consistent throughout the Bora trial with the predecessor pivotal trials.
The most commonly-reported adverse events included upper respiratory tract infection, worsening asthma, headache, bronchitis and acute sinusitis, the company noted.
“The Bora data are important news for patients with severe eosinophilic asthma who need a treatment with sustained efficacy to help control their disease, and with a safety profile that supports long-term use,” Sean Bohen, EVP of global medicines development & CMO, said in prepared remarks.
“As a clinician, I am excited by the Bora trial results, which provide confidence to patients with severe eosinophilic asthma and physicians that the positive outcomes they are seeing with Fasenra can be maintained over a second year of treatment. In Fasenra, we have a biologic treatment that can improve outcomes for these patients long-term,” lead investigator Dr. William Busse added.