Company: AZN
Filing Date: 2025-10-20
Form Type: 6-K
Source: 0001654954-25-011943
Chunk: 3

Company: ASTRAZENECA PLC
Filing Date: 2025-10-20
Form: 6-K
Chunk 3
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-positive SLE while receiving standard therapy (oral corticosteroids, antimalarial, and/or immunosuppressants). 20

The reduction of disease activity was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. 20 The BICLA requires improvement in all organs with disease activity at baseline with no new flares. 20

Participants (367) were randomised 1:1 to receive 120mg subcutaneous dose of anifrolumab or placebo administered via a pre-filled, single-use syringe. 20 A planned interim analysis was conducted when the first 220 participants reached week 52. 20 The trial also includes an open-label extension period of 52 weeks for participants who completed the 52-week treatment period. 20

Saphnelo subcutaneous administration

Since 2021, Saphnelo has been available in an IV infusion administered by healthcare professionals in a hospital or clinic setting. The potential option for a subcutaneous administration with Saphnelo will enable patients and caregivers to administer the medicine at home or in clinic via a simple process.

#### 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. 5,21 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE. 22-27

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. 28-31

#### 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