AstraZeneca PLC's Asthma Drug Hits Phase III Goal, Predicted to Reach Market in 2017

Published: May 18, 2016

AstraZeneca's Asthma Drug Hits Phase III Goal, Predicted to Reach Market in 2017 May 17, 2016
By Mark Terry, BioSpace.com Breaking News Staff

London-based AstraZeneca reported today that its drug for asthma, benralizumab, showed positive results in two pivotal Phase III clinical trials, SIROCCO and CALIMA.

Benralizumab is an anti-eosinophil monoclonal antibody, which appears to deplete eosinophils in the bone marrow, blood and target tissue. Eosinophils are cells that cause inflammation and drive hyper-responsiveness in the airways in about 50 percent of asthma patients.

The drug was developed by AstraZeneca’s MedImmune unit. It was in-licensed from BioWa, a subsidiary of Kyowa Hakko Kirin. Kyowa Hakko Kirin/BioWa has exclusive development and commercialization rights to develop benralizumab in Japan and specific countries in Asia. AstraZeneca holds the rights to the drug in all other countries, including the U.S. and Europe.

“Severe asthma affects the health and quality of life of millions of people around the world, and exacerbations can be life threatening for these patients,” said Sean Bohen, AstraZeneca’s executive vice president, Global Medicines Development, and chief medical officer, in a statement. “We are pleased with the top-line results from these pivotal trials as they demonstrate the potential for benralizumab to improve the outcomes for patients with severe asthma. Benralizumab is AstraZeneca’s first respiratory biologic and its development underscores our commitment to transform the treatment of asthma and chronic respiratory diseases with our next generation of respiratory medicines.”

There is some debate as to the potential revenue for this drug. In previous statements, AstraZeneca has suggested it could eventually hit $2 billion in yearly sales. Analysts tend to be more skeptical because there are several other recently approved drugs on the market for asthma, including GlaxoSmithKline 's Nucala and Teva ’s Cinqair. According to Thomson Reuters, annual sales forecasts for the drug are at $450 million by 2021, well off AstraZeneca’s projections.

Richard Parkes, an analyst with Deutsche Bank , predicts the market for severe asthma drugs could hit more than $7 billion a year, but more needs to be known about benralizumab to really drill down on its commercial prospects.

Both clinical trials, SIROCCO and CLIMA, are part of a comprehensive WINDWARD program in asthma, which is made up of six Phase III clinical trials in 3,068 patients at 798 sites in 26 countries.

In both trials, patients were randomized and received 30 mg of benralizumab every four weeks, or every four weeks for the first three doses followed by 30 mg every eight weeks.

There is a third trial underway, VOYAGER, which is studying benralizumab in patients with severe chronic obstructive pulmonary disease (COPD).

Not much detail has been given about the results of the trials, other than to indicate they were positive. Results will be presented at an as-yet-unidentified meeting, and regulatory submissions for the U.S. and Europe are expected in the second half of this year.

“We are learning more about different sub-types of asthma, and these trials investigate a potential new treatment to address the underlying driver for some patients,” said Mark FitzGerald, director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute, as well as principal investigator in the CALIMA trial, in a statement. “Within the appropriate patient population, the anti-eosinophil effect of benralizumab has the potential to deliver uniquely-targeted treatment for patients whose asthma is driven by eosinophilic inflammation.”

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