AstraZeneca plc (LSE:AZN; NYSE:AZN) said it does not plan to submit regulatory applications for Fasenra benralizumab to treat chronic obstructive pulmonary disease after the drug missed the primary endpoint of reducing exacerbations in a second Phase III trial in the indication.
The 56-week TERRANOVA trial enrolled about 2,255 patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils. Patients received placebo or one of three doses of subcutaneous Fasenra as an add-on to dual or triple inhaled standard of care (SOC). AZ plans to submit the data for presentation at a medical meeting.
This month, AZ reported that Fasenra missed the same primary endpoint in the Phase III GALATHEA trial in the indication (see BioCentury Extra, May 11).
Fasenra, a humanized mAb against IL-5 receptor alpha (IL5RA; CD125), is approved in the U.S., EU, Japan, Canada and Australia as an add-on therapy to treat severe eosinophilic asthma. AZ and its MedImmune LLC unit have rights to the drug from the BioWa Inc. subsidiary of Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151).