Company: AZN
Filing Date: 2025-09-17
Form Type: 6-K
Source: 0001654954-25-010847
Chunk: 3

Company: ASTRAZENECA PLC
Filing Date: 2025-09-17
Form: 6-K
Chunk 3
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 safety of a subcutaneous administration of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive SLE while receiving standard therapy. 5

Patients recruited were aged 18 to 70 years and must have been taking either one or any combination of the following: oral corticosteroids, antimalarial, and/or immunosuppressants. In the trial, 367 participants on standard therapy were randomised 1:1 to receive 120mg subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorised prefilled syringe. A planned interim analysis was conducted when the first 220 participants reached week 52. The trial also includes an open-label extension period of 52 weeks for participants who completed the 52-week treatment period. 5

#### Saphnelo
Saphnelo (anifrolumab) is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN. 2,22 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE. 24-29

Saphnelo continues to be evaluated in diseases where type I IFN plays a key role, including Phase III trials in cutaneous lupus erythematosus, myositis, systemic sclerosis and lupus nephritis. 30-33

#### AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

#### AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and