Top 5 Clinical Setbacks of 2014: AstraZeneca’s benralizumab.
The final piece in SCRIP and Datamonitor Healthcare’s top 5 clinical setbacks in 2014 so far, takes a look at the respiratory disease space.
2014 has been a trying year for AstraZeneca, and adding to its takeover fears, it experienced a setback to its much-hyped respiratory portfolio when its anti-IL-5 targeting monoclonal antibody, benralizumab, failed to meet its primary endpoint in a Phase IIa trial in chronic obstructive pulmonary disease (COPD).
Benralizumab did not reduce the acute exacerbation rate compared with placebo in the overall population in Phase II. In the trial, there was also a higher incidence of serious treatment-emergent adverse events (TEAEs) in the benralizumab group compared with placebo (14 vs 9). However, Phase III testing of the product, which had already been initiated, is to proceed.
The investigators and the company still see potential for the product however. “Benralizumab is the first biological agent to show marked reduction in eosinophilic inflammation and beneficial effects in COPD, indicating a potential new way to treat patients with severe COPD symptoms,” lead investigator Professor Christopher Brightling, University of Leicester, Glenfield Hospital, Department of Respiratory Medicine, said at the time. “The strength of these results reinforces the further development of this molecule for COPD.” AstraZeneca has penciled in a filing for 2016 in the US and EU even though the product has not fared well so far in 2014.
But analysts at BioMedTracker say its effects are far less clear cut than those in asthma and put its chances of approval in COPD at 3% below average at 65%.
Benralizumab was in-licensed from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin.
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