AZ’s lupus drug fails to curb lupus activity at Phase 3

pharmafile | August 31, 2018 | News story | Medical Communications, Research and Development AstraZeneca, Lupus, anifrolumab, pharma 

AstraZeneca and its biologics R&D arm MedImmune have released a statement admitting that their fully human monoclonal antibody anifrolumab failed to meet its primary endpoint in a Phase 3 trial investigating its efficacy in the treatment of moderate-to-severe systemic lupus erythematosus (SLE) in adult patients.

Specifically, the therapy failed to demonstrate a statistically significant reduction in disease activity after 12 months of treatment as measured by the SLE Responder Index 4 (SRI4).

An autoimmune disease, SLE affects around five million people around the world and causes the immune system to mistakenly attack healthy tissue in the body rather than true threats such as viruses. This leads to a range of symptoms including fatigue, pain, rashes and swelling of the joints. In the last six decades, only one new treatment has seen approval for the disease.

Commenting on the new data, Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “SLE is a debilitating autoimmune disease with significant unmet need among patients who struggle to achieve meaningful disease control. The result of this trial is disappointing for patients and the lupus community.”

The company confirmed that a full evaluation of these findings will be presented a future medical meeting.

Matt Fellows

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